Quality Procedures
Manual
101 Windfall Rd.
Broussard, LA 70518
337-330-4430 (main)
337-839-8542 (fax)
www.aitmachine.com
Prepared and Maintained in accordance with:
A.P.I. Spec. Q1 and ISO 9001:2008
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
Distribution Page
Company
Person
Issue #
Preface 1
Revision/Date
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
Index of Operating Procedures
Preface 2
PROCEDURE
PROCEDURE TITLE
Preface 1
Preface 2
Preface 3
QP-4.1.3.0
QP-4.1.4.5
QP-4.2.3.0
QP-4.3.2.2
QP-4.3.2.3
QP-4.4.1.2
QP-4.4.3.4
QP-4.5.0.0
DISTRIBUTION PAGE
INDEX OF OPERATING PRODRUES
CONTROLLED COPY/APPROVAL FORM
QUALITY OBJECTIVES
PLANNING AND COMMUNICATION
MANAGEMENT REPRESENTATIVE
PERSONNEL COMPETENCE
TRAINING AND AWARENESS
DOCUMENTATION REQUIREMENTS
CONTROL OF DOCUMENTS
CONTROL OF RECORDS
CONTRACT REVIEW, PLANNING, RISK ASSESSMENT &
MANAGEMENT
DESIGN AND DEVELOPMENT (N/A – excluded)
CONTINGENCY PLANNING
SUPPLIER EVALUATION, APPROVAL AND REEVALUATION
PURCHASING
PRODUCTION PROVISION
SERVICING PROVISION (N/A at this time)
VALIDATION OF PROCESSES FOR PRODUCTION AND
SERVICING
IDENTIFICATION AND TRACEABILITY
PRODUCT INSPECTION AND TEST STATUS
PRESERVATION OF PRODUCT
INSPECTION
TESTING (N/A at this time)
PREVENTIVE MAINTENANCE
CONTROL OF TESTING, MEASURING AND MONITORING
EQUIPMENT
CONTROL OF NONCONFORMING PRODUCT
MANAGEMENT OF CHANGE (MOC)
CUSTOMER SATISFACTION
INTERNAL AUDIT
ANALYSIS OF DATA
IMPROVEMENT
MANAGEMENT REVIEW
USE OF API MONOGRAM (N/A at this time)
QP-5.1.2.3
QP-5.4.1.7
QP-5.5.1.2
QP-5.6.1.6
QP-5.6.2.3
QP-5.7.1.1
QP-5.7.1.2
QP-5.7.1.5
QP-5.7.3.0
QP-5.7.4.0
QP-5.7.6.0
QP-5.7.7.2
QP-5.7.7.3
QP-5.7.8.0
QP-5.8.0.0
QP-5.10.1.5
QP-5.11.0.0
QP-6.2.1.0
QP-6.2.3.3
QP-6.3.0.0
QP-6.4.0.0
QP-6.5.0.0
QP-A.4.5.6
DATE REV.
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Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROLLED COPY/
APPROVAL FORM
Manual Number
AITM-003 – Quality Procedures Manual
Revision
Rev. 3 – 5.03.2014
Issued To
Document Control
Company
XXXXXXXX, LLC.
Preface 3
In its original digital form, this manual is classified as "CONTROLLED" and shall be maintained and
regarded accordingly. This manual loses its “controlled” designation once it is printed. The holder is a
registered recipient of this manual and may request revised versions as they become effective. This
manual is a proprietary document and will at all times remain the property of XXXXXXXX and may be
recalled at any time. If you would like information concerning the procedures and policies governing
this manual, please phone at xxxxxxxx.
APPROVALS
President:
Date: 5/03/2014
Quality Manager:
Date: 5/03/2014
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
QUALITY OBJECTIVES
1.
SECTION: QP-4.1.3.0
SHEET: 1 OF 1
PURPOSE
The purpose of this procedure is to establish Quality Management System (QMS) objectives and a
uniform procedure for measuring those objectives.
2.
SCOPE
This procedure shall be followed in any location where XXXXXXXX, LLC is licensed by the American
Petroleum Institute.
3.
PROCEDURE
The QHSE Manager or his designee is responsible for the development of quality objectives which
should include the following as a minimum:
a)
Key Performance Indicators (KPIs)
b)
Goals
c)
Conformance to Product Requirements
d)
Reduction of Non-Conformance
e)
Increase Customer Satisfaction
Summarize the information as required in the “Analysis of Data” section of these procedures.
Review the results of the QMS objectives and overall performance for the time period being audited
and present the data as required in the “Management Review” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PLANNING & COMMUNICATION
1.
SECTION: QP-4.1.4.5
SHEET: 1 OF 1
PURPOSE
To describe the methods of planning, establishing, implementing and maintaining the Quality
Management System (QMS) at XXXXXXXX, LLC and communicating the requirements throughout the
organization.
2.
SCOPE
This procedure is applicable for all XXXXXXXX, LLC locations.
3.
PROCEDURE
Management and the appointed Management Representative are responsible for planning and
communicating the control features of the QMS.
Determine, establish and manage the necessary document tiers of procedures, work instructions,
process control plans or quality plans to effectively address and implement each area of the QMS as
outlined in API Specification Q1.
a)
Include product specification requirements relative to those products that XXXXXXXX, LLC
manufactures for its customers.
b)
Include the necessary forms to create records that serve as evidence of conformance to the
procedures.
Sequence and interaction of processes and QMS documents at XXXXXXXX, LLC are described in the
“Documentation Requirements” section of these procedures.
The Quality Policy is contained in the Quality Manual (Sec. 3).
Review and communicate the areas of the QMS relevant to respective job descriptions throughout the
organization via QMS training as described in the “Training and Awareness” section of these
procedures.
Maintain awareness of the system and any significant changes through meetings, interim training,
process or product alert memorandums, postings and any other means of communicating the
importance of the QMS.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT REPRESENTATIVE
1.
SECTION: QP-4.2.3.0
SHEET: 1 OF 2
PURPOSE
To describe appointment, authority and responsibilities of the Management Representative to ensure
that the XXXXXXXX, LLC quality standards for products and services are adhered.
2.
SCOPE
The Quality Management Representative shall have the authority and responsibility to ensure
implementation of the control features described below which are applicable for all XXXXXXXX, LLC
locations.
3.
PROCEDURE
A member of XXXXXXXX, LLC management is appointed by the President/Owner as the
Management Representative and that job title is identified on the organization chart.
The Management Representative has the authority (or delegates the authority) and is responsible for
implementation of the Quality Management System (QMS) as described below.
Establish the necessary documents as required in the “Planning and Communication” section and
“Documentation Requirements” section of these procedures.
Arrange for the necessary training of personnel as required in the “Training and Awareness” section
of these procedures to ensure their familiarity with the procedures.
Implement methods for ensuring conformance with the procedures as required in the “Monitoring
and Measurement” section of these procedures.
Report the performance of the QMS to management as required in the “Management Review” section
of these procedures.
Periodically review the processes and procedures for continuous improvement towards customer
satisfaction.
Assess processes and products for potential problems and implement preventive action to avoid
nonconformities as required in the “Preventive Action” section of these procedures.
Maintain current customer specifications and requirements, review changes when revised and
emphasize or promote awareness of customer requirements with personnel whose work affects
finished products.
Arrange and ensure that internal quality audits are conducted according to schedules as required in
the “Internal Audit” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT REPRESENTATIVE
SECTION: QP-4.2.3.0
SHEET: 1 OF 2
Confirm that suppliers are evaluated as required in the “Supplier Evaluation, Approval and
Reevaluation” section of these procedures and only those approved are used for the purchases that
affect the quality of products or services provided to XXXXXXXX, LLC customers.
Act as liaison with outside agencies conducting audits of XXXXXXXX, LLC.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-4.3.2.2
SHEET: 1 OF 2
PERSONNEL COMPETENCE
1.
Purpose
The purpose of this procedure is to describe the methods for ensuring personnel competency of
various job titles at XXXXXXXX, LLC
2.
Scope
To assure that personnel assigned to job titles have responsibilities defined and are qualified, trained,
and competent to carry out their responsibilities at all XXXXXXXX, LLC facilities based on their
respective job title as defined by the job description manual (AITM-056).
3.
Procedure
Respective department management personnel are responsible for defining the degree of
competence necessary for each job title and final approval of the job description.
Qualifications may be based on statutory or regulatory requirements, industry standards or
manufacturer specifications, where applicable.
a)
Individual qualification requirements are defined by the activity being managed, performed
or verified as outlined in the job description.
b)
The need for qualification in specific disciplines is based on each individual’s area of expertise
and their job functions.
Qualification requirements are defined in each respective job description to include the following.
a)
Each job description shall contain pertinent information regarding the position.
b)
Summarize the job description of the job title and define the job title to whom that position
reports.
c)
Outline the job duties and responsibilities.
d)
Define the necessary knowledge, skills and abilities to perform the job.
e)
Define the credentials and minimum experience necessary for the position.
f)
Minimum education level.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PERSONNEL COMPETENCE
SECTION: QP-4.3.2.2
SHEET: 1 OF 2
Individuals who perform work that affects product or service quality are trained as required in the
“Training and Awareness” section of these procedures.
Qualification/certification records are maintained as required in the “Quality Records” section of
these procedures.
An organizational chart is attached which shows the job titles and hierarchy of the organization.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
TRAINING & AWARENESS
1.
SECTION: QP-4.3.2.3
SHEET: 1 OF 3
Purpose
To define the method and means by which training, indoctrination qualification of personnel shall be
accomplished and documented.
2.
Scope
To assure that personnel assigned to job titles are adequately trained to carry out their
responsibilities at all XXXXXXXX, LLC facilities based on their respective job title as defined in the job
description manual (AITM-056).
3.
Procedures
Personnel Training Needs
Respective department management personnel are responsible for defining the necessary training for
each job title and final approval of the job description.
The required training is mandatory and administered as defined in the job description for the job
title within three months of the hire date.
Interim training shall be scheduled by management as needed whenever significant revisions are
made to the policies and/or procedures affecting the content of the course or whenever an employee’s
job title or job function has been altered, as determined by management.
a)
Minor changes as determined by the QHSE manager may be discussed and reviewed during
meetings with affected personnel.
General training shall include courses involving policy and procedural awareness relative to the
Quality Management System, Health, Safety & Environmental and other disciplines.
Auditor training shall consist of taking part in a minimum of (2) XXXXXXXX internal audits and/or
attending and successfully confirming comprehension of a course developed and conducted by a
qualified instructor and the course shall include thorough lessons in areas described below. Potential
auditors are selected as stated in the “Quality Audits” section.
a)
All of the elements involved with API Specification Q1.
b)
Audit planning and scheduling.
c)
Development of an audit checklist.
d)
Collecting objective evidence.
e)
Writing non-conformances.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-4.3.2.3
SHEET: 2 OF 3
TRAINING & AWARENESS
f)
Effective corrective and preventive action.
g)
Follow-up, verification and closure.
Specific training is developed based on knowledge of subject matter experts, industry standards,
Original Equipment Manufacturers specifications or brochures and shall include competence
verification. Specific training includes (but not limited to) machine operators, programmers, product
designers, maintenance technicians and inspectors.
Responsibility for Conducting Training
The Human Resource Manager and QHSE Manager are jointly responsible to ensure the training is
administered.
The QHSE Manager is responsible for ensuring that instructors are qualified.
Instructors that train personnel shall meet the following minimum requirements:
a)
Auditor Instructors shall meet the following requirements.






b)
Possess a high school education or equivalent.
Received on job training (OJT) for a minimum period of three months with XXXXXXXX,
LLC
Have a minimum two years of experience as an auditor, inspector or supervisor in a
quality-related position.
Possess training by a hired consultant or previous certification as an auditor by an
accredited organization such as the International Standards Organization (ISO), Det
Norske Veritas (DNV), American Society of Quality (ASQ) or the American
Petroleum Institute (API).
Have extensive knowledge of quality-related industry standards.
Be capable of developing a training course for auditors containing corresponding
information relative to these procedures and confirm the comprehension.
Health, Safety & Environment (HSE) Instructors shall meet the following requirements.






Possess a high school education or equivalent.
Received on job training (OJT) for a minimum period of three months with XXXXXXXX.
Either possess training by a hired consultant or previous certification as a safety
instructor by an accredited organization.
Possess extensive knowledge of safety-related industry standards.
Meet XXXXXXXX, LLC requirements for instructors that are specific to certify personnel
to operate certain types of equipment (e.g., fork lift or overhead crane) or to certify
personnel in life saving techniques and/or medical first aid assistance (e.g., CPR/First
Aid or water survival) or environmental incident prevention/response.
Be capable of developing a training course as required, conduct the training, and
confirm the comprehension.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-4.3.2.3
SHEET: 3 OF 3
TRAINING & AWARENESS
c)
Quality Management System (QMS) Instructors shall meet the following requirements.





d)
Possess a high school education or equivalent.
Received on job training (OJT) for a minimum period of three months with XXXXXXXX,
LLC.
Possess general knowledge of manufacturing/machining oilfield products.
Satisfy the necessary quality auditor qualifications as described within this
procedure or
Attend training by a qualified QMS instructor and conduct a minimum of one
training session while monitored by the qualified instructor.
Specific Training Instructors shall meet the following requirements.






Possess a high school education or equivalent.
Received on job training (OJT) for a minimum period of six months with XXXXXXXX,
LLC.
Have a minimum of one year experience in manufacturing/machining oilfield products.
Possess adequate knowledge of XXXXXXXX, LLC products, machinery, software
knowledge and ability to operate within the XXXXXXXX, LLC network and programs.
Possess a working knowledge of XXXXXXXX, LLC HSE and QMS requirements and
procedures.
Be capable of developing a training course as required, conduct the training, and
confirm the comprehension.
Maintain training records as required in the “Quality Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
DOCUMENTATION REQUIREMENTS
1.
SECTION: QP-4.4.1.2
SHEET: 1 OF 2
PURPOSE
The purpose of this section is to describe the documents required as derived from the “Planning and
Communication” section of these procedures for the implementation, and maintenance of the
XXXXXXXX, LLC Quality Management System (QMS).
2.
SCOPE
This procedure is applicable for the QMS developed for the manufacturing activities of XXXXXXXX,
LLC. Design, Development, Testing, and Servicing are not applicable at this time due to the nature of
our license and registration.
3.
PROCEDURE
XXXXXXXX, LLC does not perform Design & Development, Testing, or Servicing at this time. All
product manufactured is to customer design and customer specifications, therefore XXXXXXXX, LLC
has no AIT designed product to test or service.
Procedures and Specifications shall be uniquely identified. The following is a list of established
procedures and their numbers to provide reference for those that control the QMS:
a)
1st Tier
XXXXXXXX, LLC Quality Systems Manual (AITM-002)
The Quality Manual contains the quality policy and addresses API Specification Q1 requirements as
applicable to the products and services that XXXXXXXX, LLC provides to customers.
b)
2nd Tier
XXXXXXXX, LLC Quality Procedures Manual (AITM-003)
Procedures are numbered “QP – X.X.X.X “
Customer Product & Material Specifications are numbered by the Customer
c)
3rd Tier
Work Instructions, General Forms, Records, & Reference Material
General forms, records, reference material, and work instructions may or may not carry a unique
document number. The typical format for general forms and records is: AITM-XXX, Rev. X –
month/day/year. Work instructions may be found on AITM-#’d documents and forms, and in many
cases are included as program notes in machining programs the operator sees as he sets up and
manufactures his part. The work instructions are typically built into whatever existing document,
form, or program that is being utilized to best ensure personnel always have the proper instruction.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
DOCUMENTATION REQUIREMENTS
d)
SECTION: QP-4.4.1.2
SHEET: 2 OF 2
Procedure Format
Quality System procedures shall be prepared with following general format:
PURPOSE: A statement of the aim, purpose, or goal of the procedure.
SCOPE: A brief and general description of the applicability of the procedure.
PROCEDURE: A description of the process or operation required to accomplish the procedure
objective. The depth of this procedure shall be as required for a qualified individual to
adequately accomplish the procedure objective. Responsibilities shall be defined. The
procedure shall include acceptance and rejection criteria where appropriate.
Quality objectives are defined in the “Quality Objectives” section of these procedures.
Processes that require validation are identified in the “Validation of Processes for Production and
Servicing” section of these procedures.
Required procedures are those derived from within API Q1 that state “the organization shall establish
procedures”.
Documents and records that serve as evidence of planning and process controls for compliance with
the QMS are contained in “Document Control” and the “Job Boss” integrated software.
Any other procedures, product specifications, or work instructions shall be written and included or
excluded from their respective manuals at the discretion of XXXXXXXX, LLC’s management.
XXXXXXXX, LLC considers its QMS to be a “living system” and will continually strive to improve the
QMS. The only constant shall be those procedures as required by API Q1.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF DOCUMENTS
SECTION: QP-4.4.3.4
SHEET: 1 OF 4
1. Purpose
This section describes the steps required for the control of documents referenced in the
“Documentation Requirements” section of these procedures and specifications to ensure their proper
identification, date, cataloging, preservation and dissemination.
2. Scope
This procedure is applicable for the Quality Management System (QMS) developed for the
manufacturing activities of XXXXXXXX, LLC.
3. Procedure
Procedures, specifications, work instructions and similar quality related documents that explain,
interpret or expand the QMS shall be reviewed and approved by the QHSE Manager prior to release.
Master quality documents are located on the XXXXXXXX, LLC network in the directory and folder
named AIT Shared Documents<Document Control.
All Supervisors/Managers have access to Document Control. Hard copies of all procedures are
maintained and kept in the Quality Department for all personnel to reference as needed.
The QHSE Manager manages electronic documents and informs employees of any updates to the
documents. The Quality Department shall maintain a Document Control File of all controlled
documents and ensure that all documents remain legible and readily identifiable.
Document control shall be exercised over all the documentation outlined in this procedure including
API Spec. Q1, International Standards and Customer drawings or specifications of external origin, and
any legal requirements needed to achieve product conformity.
For documents issued directly from another company, the originating company retains responsibility
for controlling the document and for maintaining revision records, master lists and distribution lists.
For drawings issued from other Companies, the Print Number and Revision will be reflected on the
Work Order/Job Traveler.
External documents are posted to the master list and/or (External) Controlled Document Issuance Log
(AITM-055) and will be issued, monitored or controlled by the Quality Team when applicable.
Out of date and old documents will be collected, destroyed and reissued when new revisions are
made. If retained for any purpose, these documents shall be marked OBSOLETE and filed in
Document Control.
When personnel use a document, it is their primary obligation to ensure that they are using the
correct and most current version. If in doubt they should check with their Supervisor or the QHSE
Manager.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF DOCUMENTS
SECTION: QP-4.4.3.4
SHEET: 2 OF 4
Records of all controlled documentation in the facility shall be entered on a Master List.
Records shall be kept in the Document Control Center. The QHSE Manager shall maintain and
monitor all controlled documents using issuance logs with issue number, person, date, revision and
title.
Identification
All internal documents are identified by their number, revision level, date of revision/issue, title, and
an authorized approval signature. In some instances, the number and revision level may not be
relevant; but as a minimum, all documents are dated and signed.
Documents of external origin will be identified by title, revision and date issued by the applicable
industry governing body.
Posted work instructions are also controlled documents. They are dated and authorized by the
Facility Manager and/or the QHSE Manager. When revised, the obsolete posted instructions are
removed and the new versions are affixed in their place.
Establishment of Initial Issues and Revisions
The initiative to establish a new, or revise an existing document, can be taken by anyone in the
organization. The person wishing a document or a revision submits a draft of the proposed document
to his or her supervisor, or the QHSE Manager. Regardless of who initiates a document, the
responsibility to review, approve and issue the document always rests with the Facility Manager and
the QHSE Manager.
Issue
Prior to issue and release of a document, it is reviewed for adequacy, correctness and conformance
with the quality policies by the QHSE Manager. A document is considered to be formally issued when
an authorized approval signature is placed on it.
Prior to the issue and release of a new procedure, it is reviewed for adequacy, correctness and
conformance with the quality policies by the QHSE Manager, feasibility by the Shop Foreman, and
scope by the General Manager. A Procedure Acceptance Form containing signatures of the General
Manager, Shop Foreman, and QHSE Manager provide authorization. When the Procedure
Acceptance Form is completed and digitally stored, the procedure is issued.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-4.4.3.4
SHEET: 3 OF 4
CONTROL OF DOCUMENTS
Placement of Initial Issues and Revisions
Only the original digital version of a document or procedure, stored in the Document Control Center,
are to be considered “Controlled”. Any time a controlled document is printed or emailed, it shall be
watermarked with “only the original digital version of this document is considered controlled”
The quality and operating procedure manuals, work instructions, Customer drawings, forms, OEM
Manuals and industry standards are posted to a master list in the Document Control Center.
Documents are placed with personnel and at locations where utilized. Supervisors also have a full set
of those documents relevant to their departments.
A newly created document will start with Revision 1. The first revision will be Revision 2 with the date
of revision in the header or footer of the revised document.
Revisions of documents are distributed to the same personnel and locations as the original issues. All
revised sections of the Quality Manual and Procedures will be shown in bolded italics to reflect the
most current revision status. All other documents will also have revised text bolded & italicized.
Document Control Center
The Document Control Center shall act as an archive in maintaining and storing all controlled and
reference documents with a master list showing the document number, most current revision status
and date, and title of all documents.
The Document Control Center shall archive all company Quality Records which are used within the
facility as referenced in the Records Summary Table in QP-4.5.0.0 Sheet 2 of 2. All records are
available upon request, with retrieval occurring within 72 hours.
Uncontrolled Copies
When issued to personnel and outside parties who are not affected by the document but need a copy
for information only, documents are stamped or watermarked as UNCONTROLLED. Such documents
are not followed up with revisions. Uncontrolled copies of documents may not be given to in-house
personnel or outside parties who manage, perform or verify work that is directly affected by the
document.
Machine Programs
The manufacturing manager or his designee is responsible for approval and storage of machining
programs.
a)
Assign machining programs a unique number.
b)
Retain the original program name and number for modified programs.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF DOCUMENTS
SECTION: QP-4.4.3.4
SHEET: 4 OF 4
c) Delete obsolete programs.
d)
Store programs in their appropriate location on the XXXXXXXX, LLC “local” server.
e)
Back up programs periodically as required.
XXXXXXXX’s Machine Programs often contain detailed work instructions on how to properly execute
the program (how to align the part, which tools to use, how to “teach” the mill or lathe) in the form
of program notes.
Customer, Legal, or Industry standards (documents of external origin) used in the design,
manufacturing and/or acceptance criteria of products are referenced in various sections of these
procedures and are accessible through a web based organization where only relevant version may be
accessed.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF RECORDS
SECTION: QP-4.5.0.0
SHEET: 1 OF 2
1. Purpose
This section describes the steps required for the control and responsibilities for records referenced in
various sections of these procedures and specifications to ensure their proper identification, collection,
storage, protection, retrieval, retention time, and disposition.
2. Scope
This procedure is applicable for the Quality Management System (QMS) developed for the
manufacturing activities of XXXXXXXX, LLC.
3. Procedure
The individual assigned in the Record Table shall be responsible for identification, collection, storage,
maintenance, protection, retrieval, retention and disposition of the referenced quality records.
Control and maintain records for a period not less than five years in any form that is retrievable
including vendor related records. Records will be disposed of in a manner that prevents further
reference – shredding.
Retain quality records in folders, Log form (binders), on the XXXXXXXX, LLC local server and/or
metal filing cabinets. Store vital records in a manner to prevent unauthorized alteration, protect
them from damage and have readily retrievable.
Verify that quality records are legible, traceable, clean, and authorized (where applicable) before
storing.
For purposes of this procedure quality records shall include, but not necessarily be limited to
a)
the results of all tests and inspections which are quality system documented,
b)
all records of corrective or preventive actions,
c)
the results of all internal audits of the quality system,
d)
all management reviews,
e)
all records which reflect the training/qualification of personnel (especially quality related
personnel),
f)
statistical techniques,
g)
equipment calibration documents,
h)
documents showing compliance with any special requirements
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-4.5.0.0
SHEET: 2 OF 2
CONTROL OF RECORDS
RECORD TABLE
Record
INSPECTION RECORDS
Inspection
Final Review
Job packet, Final Review
Test Charts
NONCONFORMANCES
Vendor Complaints
Customer Complaints
Out of Tolerance Reports
PROCEDURE MASTER FILE
Procedures
EMPLOYEE TRAINING FILES
Job Specific Requirements
Training Records
PROCESS CONTROL
Job Traveler
CONTRACT REVIEW
Customer PO
Quotes
AUDITS
Internal
Audit Summary
Check List
Supplier
Quality System Survey Report
MANAGEMENT REVIEW
Minutes
CALIBRATION RECORDS
Internal
Independent Lab
Corresponding
Procedure
Retention
Period
Responsible
Party
Indexed
By:
Storage
Method
5 Years
5 Years
5 Years
7 Years
QHSE Manager
QHSE Manager
QHSE Manager
QHSE Manager
WO#
WO#
WO#
WO#
File cabinet/server
File cabinet/server
File cabinet/server
File cabinet/server
5 Years
5 Years
5 Years
QHSE Manager
QHSE Manager
QHSE Manager
WO#
WO#
WO#
File cabinet/Server
File cabinet/Server
File cabinet/Server
5 Years
QHSE Manager
Procedure
No.
Server
Length of
Employmen
t
+ 5 Years
"
QHSE Manager
Employee
Name
Server
"
"
"
5 Years
QHSE Manager
WO#
File cabinet
5 Years
5 Years
Office Manager
Office Manager
SO #
Quote #
File cabinet
File cabinet
5 Years
5 Years
QHSE Manager
QHSE Manager
Date
Date
File cabinet
File cabinet
5 Years
QHSE Manager
Supplier
File cabinet/Server
5 years
QHSE Manager
Date
File cabinet/Server
5 Years
QHSE Manager
Gage No.
File cabinet/Server
5 Years
QHSE Manager
Gage No.
File cabinet/Server
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTRACT REVIEW, PLANNING,
& RISK ASSESSMENT/MANAGEMENT
1.
SECTION: QP-5.1.2.3
SHEET: 1 OF 4
Purpose
This section describes the processes for the review of customer contracts at XXXXXXXX, LLC as
required by this Quality Management System (QMS).
2.
Scope
To assure that contracts received for processing are reviewed in a timely fashion and to determine
that all requirements are adequately defined, documented, and/or agreed upon by both parties.
Also that any differences between orders and tenders are resolved and that XXXXXXXX, LLC has the
ability and capacity to meet the contract or order requirements.
3.
Procedure
Contract Review: Determination of Requirements
Marketing, inside sales, QA/QC and operations personnel are responsible for obtaining the necessary
information and requirements from customers.
Include the following minimum information on the quote and/or purchase order in no particular
order:
a)
Date
b)
Shipped via.
c)
Ordered by
d)
Customer number
e)
Quantity
f)
Part number
g)
Delivery date
h)
Purchase order
Evaluate and add applicable product specifications or legal requirements for the product(s) that the
customer may have failed to communicate.
Maintain records of the determination as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTRACT REVIEW, PLANNING,
& RISK ASSESSMENT/MANAGEMENT
SECTION: QP-5.1.2.3
SHEET: 2 OF 4
Contract Review: Review of Requirements
The Operations Manager or his designee is responsible for conducting contract reviews.
The Operations Manager or his designee shall:
Verify that customer requirements are clearly documented.
Ensure any differences between the contract or order requirements are resolved with the customer in
advance.
Verify XXXXXXXX, LLC has the capability to meet the contract/order requirements.
Ensure XXXXXXXX, LLC identifies how amendments to a contract/order is made and correctly
transferred to the functions concerned.
Maintain records of the review as required in the “Control of Records” section of these procedures.
The Customer shall furnish requirements to XXXXXXXX in the form of a request for quotation, via
phone, fax, email or purchase order
Order Entry
Customer job inquiries shall be logged in a quotation file with date and Customer name. A quote is
generated specifying costs, conditions, and delivery time of product. All quote information is filed in
a complete quote file.
The customer accepts the quotation (agreeing to the terms of our contract) and issues a purchase
order to XXXXXXXX. Once the customer issues their purchase order, the Operations Manager or his
designee will generate a work order. When a work order is created, it is indicating the review and
acceptance of the Customer order, closing out Contract Review.
A Work Order/Job Traveler or floor copy (router) is issued. The Job Traveler consists of a Shop/Work
Order, engineering prints, special instructions, a dimensional worksheet and purchase orders.
XXXXXXXX’s schedule is reviewed and/or revised to establish a delivery date. The Work Order/Router
is completed showing all process instructions, hold and check points and delivery dates.
If raw material is needed a Purchase Order is issued. When material is ordered, the Work Order is
held in the Waiting on Material Bin. All travelers- ordered material & customer supplied materialare held in the Waiting on Material Bins until material is delivered and approved.
The Receiving Agent reviews all receiving documentation for final approval. Applicable receiving
documents (such as MTR) are placed in the job packet and then issued to the appropriate work
station.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTRACT REVIEW, PLANNING,
& RISK ASSESSMENT/MANAGEMENT
SECTION: QP-5.1.2.3
SHEET: 3 OF 4
Changes and/or amendments to a contract/order shall be made by management. Customers will be
required to submit any change to a contract/order in writing, verbally, via fax, or mail with an
authorized signature before any changes can be made to an existing or planned order.
Signatures or initials and date by changes made to the contract/order, purchase order and/or work
order will serve as approval and verification by XXXXXXXX and customer representatives.
The QHSE Manager, Operations Manager, Sales Manager, or Shop Foreman will be responsible for
noting changes and date of changes on all applicable documents.
Planning
The Operations Manager shall plan product realization as referenced in the various sections of the
QMS:
a)
Provision of Resources
b)
Review of Customer, Legal, or Other Requirements
c)
Risk Assessment and Contingency Planning
d)
Inspection and Testing
e)
Management of Change
f)
Process Control Documents
Route the order information directly to the Programmer for the generation of work instructions and
Mill/Lathe programs.
Route the order information directly to the production department to schedule manufacturing of
items.
Route the order information
criteria/documentation.
to
QHSE
Manager
for
the
generation
of
inspection
Conflicting Requirements:
The Operations Manager and/or QHSE Manager shall handle conflicting requirements that arise
during manufacturing, whether strictly between the customer’s own requirements or between the
customer’s requirements and an applicable industry standard, as follows:
a)
All work on the product, regardless of the process, shall be placed on hold.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTRACT REVIEW, PLANNING,
& RISK ASSESSMENT/MANAGEMENT
SECTION: QP-5.1.2.3
SHEET: 4 OF 4
b)
Any changes resulting from the customer communication shall be received either by email or
fax and handled as required in “Review of Requirements” above.
c)
The Sales representative, Operations Manager, Programmer, or QHSE Manager shall contact
the customer and resolve the conflicting issue(s).
d)
After another contract review has taken place, work may resume on the product in question.
Maintain records for the planning as required in the “Control of Records” section of these procedures.
Risk Assessment and Management
The Risk Assessment Chart below should be used to determine the degree of risk involved with
product delivery and product quality.
Likelihood
Risk
Assessment
Chart
Improbabl
e
Unlikely
Moderate
Likely
Probable
Very low
Low
Impact Severity
Medium
High
Extreme
Minor
Concern
Concern
Acceptable
Acceptable
Minor concern Minor concern
Concern
Acceptable
Minor concern
Concern
Concern
Concern
Minor concern Minor concern
Concern
Concern
Major concern
Concern
Concern
Concern
Major concern Contingency
Acceptable
Acceptable
Acceptable
For product delivery, consider facility and equipment availability as well as the maintenance
thereof, supplier performance and material availability.
For product quality, consider delivery of nonconforming product and the availability of competent
personnel.
Assess each consideration for likelihood of occurrence and impact severity. No further action is
required for those risks determined as “acceptable” and/or “minor concern”. Contingency plans
and/or preventive action plans may be implemented for those determined a “concern”.
Schedule meetings with involved personnel to include an agenda of discussion items to entertain and
impose for risks determined to be a “major concern”. Record meeting minutes and action items
defining responsibilities.
Develop a formal written contingency plan as described in the “Contingency Planning” section of
these procedures and/or preventive action items defining responsibilities when risks determine that a
“contingency” is required.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
.
1.
DESIGN & DEVELOPMENT
(EXCLUDED)
SECTION: QP-5.4.1.7
SHEET: 1 OF 3
Purpose
This procedure describes the methods to plan and control the design of products at XXXXXXXX, LLC
2.
Scope
This procedure encompasses the methods for designs generated by XXXXXXXX, LLC as required by
the Quality Management System (QMS).
3.
Procedure
XXXXXXXX, LLC does not perform any Design or Development activities and is
excluded from Design & Development by nature of their license and registration with
API.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-5.5.1.2
SHEET: 1 OF 2
CONTINGENCY PLANNING
1.
PURPOSE
This section describes methods for the establishment of contingency plans at XXXXXXXX, LLC as
required by this Quality Management System (QMS).
2.
SCOPE
To assure that plans are developed for potential incidents that could affect the delivery or quality of
products or services provided to customers at all XXXXXXXX, LLC locations.
3.
PROCEDURE
The Operations Manager is responsible for ensuring that contingency plans are developed for risks
that are likely to occur and potentially result in having a severe impact or consequence regarding
customer satisfaction.
Authorize an individual from the respective department that would be responsible for the potential
incident to develop the plan(s) based on the risk assessment requirements in the “Contract Review”
section of these procedures.
Develop options or recommendations for preventing, avoiding, eliminating or mitigating the degree
of affect that the potential incident would have on delivery or quality of the product(s).
Plans should include some of the following options based on the potential incident(s):
a)
Preventive maintenance of equipment
b)
Purchase different types, new or additional equipment
c)
Upgrade existing equipment
d)
New computer hardware or software technology and/or programs
e)
Increase quantities of stock items
f)
Subcontract machining or fabrication services
g)
Audit or evaluate approved suppliers
h)
Solicit different suppliers based on quality, delivery or logistics
i)
Purchase different types of material
j)
Changes to facility space or arrangement
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTINGENCY PLANNING
SECTION: QP-5.5.1.2
SHEET: 2 OF 2
k)
Changes to processes or methods of manufacturing
l)
Train, add or replace personnel
m)
Assign project managers or teams for expediting or managing specific tasks
Submit the options and recommendations to the Operations Manager for review and approval.
Implement changes as required in the “Management of Change” section of these procedures.
Maintain records of contingency planning as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SUPPLIER EVALUATION, APPROVAL,
SECTION: QP-5.6.1.6
& REEVALUATION
SHEET: 1 OF 4
1.
Purpose
This procedure defines “non-critical” and “critical” materials or services and describes the methods for
selection, evaluation, approval and re-evaluation of suppliers and subcontractors.
2.
Scope
To provide a process for the evaluation, approval and periodic re-evaluation of suppliers providing
materials and services that directly affect the quality of products or services provided to XXXXXXXX,
LLC customers as required by this Quality Management System (QMS).
3.
Procedure
Critical products or services are those provided to the company that would likely have catastrophic
consequences to the company should the product or service result in failure. Examples include:
a)
Raw material and products that the company provides to customers such as steel alloys and
plastics
b)
Sub-contracted machining services, heat treatment, coating, and EDM services
c)
Processing equipment such as forklifts, overhead cranes and jib cranes
d)
Lifting equipment such as slings and shackles
Significant products or services are those provided to the company would likely have serious
consequences to the company should the product or service result in failure. Examples include:
a)
Logistics providers
b)
Facility maintenance contractors
c)
Calibration services for inspection, measuring and test equipment
d)
Equipment that the company utilizes for manufacturing products provided to customers
e)
Personal protective equipment for personnel
f)
High-risk tools such as grinders, saws and torque equipment
g)
Hazardous chemical, liquid and gas products including providers of the containers and waste
re-cycling contractor
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SUPPLIER EVALUATION, APPROVAL, &
REEVALUATION
SECTION: QP-5.6.1.6
SHEET: 2 OF 4
Minimal products or services are those provided to the company that would likely have no serious
consequences to the company should the product or service result in failure. Examples include:
a)
Lubricants, paints & non-hazardous chemicals
b)
Consumables such as fasteners, washers, tie-wraps, etc.
c)
Low-risk tools such as pressure washers, drills, brushes, etc.
d)
Facility storage and work shop products such as protectors, racking, work benches, etc.
e)
Office products
f)
Information technology (IT) products and services
g)
Packaging supplies and services
h)
Office cleaning services
Initial Supplier Evaluation
Managers of the respective department or area making the purchase are responsible for ensuring
that the selection and approval process is adhered.
Authorization to proceed while the assessment process is ongoing may be granted by the Operations
Manager and is dependent on the associated level of risk and designated control features.
QHSE personnel are responsible for maintaining the Approved Vendor/Supplier List (AITM-034) of
critical, significant and minimal suppliers, which shall include the products and/or services that each
may provide according to the supplier location.
Select suppliers based on logistics, economics, the ability to meet the requirements within this QMS
and delivery capabilities to obtain the best value at the time of purchase. “Best value” shall not be
construed as the “lowest price”. Other considerations include delivery time, support, material or
service quality, reliability and operating life expectancy.
Suppliers possessing an established QMS are preferred.
Suppliers that were approved prior to the implementation of this procedure are subject to the
supplier reevaluation section as described below in this procedure.
Any department can complete and submit an approved “Quality System Survey” form (AITM-030 –
Supplier Assessment Form – “SAF”) directly to the QHSE Manager for entry into the purchasing
system for new suppliers that will provide only products or services classified as minimal.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SUPPLIER EVALUATION, APPROVAL, &
SECTION: QP-5.6.1.6
REEVALUATION
SHEET: 3 OF 4
The QHSE department is responsible for the evaluation of all critical or significant suppliers and shall:
a)
Send a SAF to the supplier and review upon return.
b)
Classify the products or services that the supplier will provide as either critical or significant.
c)
One or more discretionary evaluations as described below shall be performed when the
completed Quality System Survey form is found acceptable for suppliers whose products or
services are classified as significant.






d)
Review the supplier’s QMS procedure documents for adequacy.
Review the supplier’s current certification from an accredited agency for a QMS.
Schedule and conduct a QHSE audit of the supplier.
Perform a first article inspection to verify conformance with stated requirements.
Conduct an on-site evaluation of the supplier.
Require a Certificate of Compliance for proprietary products or services.
Two or more additional discretionary evaluations described below shall be performed when
the completed Quality System Survey form is found acceptable for suppliers whose products or
services are classified as critical.






Review OEM licenses and approvals (required for second party suppliers and
subcontractors).
Review industry standard certifications or licenses (required for third party suppliers and
subcontractors).
Review QHSE performance records of the supplier.
Review domestic legislative licenses.
Randomly interview the potential supplier’s top customers for competence and
performance indicators.
Investigate whether any prosecutions exist with the potential supplier.
Complete the remainder of the SAF form for those found acceptable and forward the completed and
approved SAF form to the initiator and the office manager for entry into the purchasing system.
Notify the initiator of the SAF form and the supplier when assessment results are unacceptable and
provide a brief summary of reasons for decline of the request and the deficiencies necessary to resolve
in order to obtain approval.
Convey all special or supplemental “Supplier Requirements” that are applicable to the product or
service to the supplier. Require acknowledgement from the supplier supporting that the special or
supplemental requirements were received.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SUPPLIER EVALUATION, APPROVAL, &
SECTION: QP-5.6.1.6
REEVALUATION
SHEET: 4 OF 4
Supplier Reevaluation
Two or more discretionary evaluations listed in “e” above shall be performed for suppliers whose
products or services are classified as critical.
Reevaluate suppliers that provide products or services classified as significant by reviewing supplier
files for discrepancies.
Reevaluate suppliers continuously, as needed, and/or upon request for additional products or services
not listed on the Approved Supplier Register and review supplier files for discrepancies.
The QHSE Department creates audit plans as necessary for suppliers. Audits are scheduled
dependent on activity levels of the specific suppliers, the products or services they provide, and their
historical performance.
Statistical analysis of data shall also be a factor during the re-evaluation of vendors. Conduct data
analysis in accordance with the “Quality Objectives” section of these procedures to assess supplier
performance.
Document non-conformances as described in the “Corrective/Preventive Action” section of these
procedures and forward the report to the supplier for corrective/preventive action.
Revoke supplier approval when reevaluations are unacceptable or if performance becomes
unsatisfactory without successful corrective and preventive action.
Notify the supplier of their removal from the approved list, including a statement regarding the
possibility of re-approval, and the deficiencies necessary to resolve in order to obtain re-approval.
Only approved suppliers are made available for creating purchase orders.
Records
Maintain records serving as evidence of conformance with the supplier evaluation, approval and
reevaluation process as required in the “Control of Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-5.6.2.3
SHEET: 1 OF 6
PURCHASING
1.
Purpose
This procedure describes methods to assure that purchase requirements are controlled in accordance
with the XXXXXXXX, LLC Quality Management System (QMS) and applicable API requirements.
2.
Scope
To provide a purchasing process for procurement of materials or services that affect the quality of
products or services provided to XXXXXXXX, LLC customers.
3.
Procedure
Purchasing Information
The following terms used in this procedure are defined below.
a)
Equipment refers to supplies, tools and machinery to be used for processing products or other
necessary resources for employees to perform duties as outlined by this QMS.
b)
Product refers to finished parts that become items provided to customers.
c)
Material refers to raw material that XXXXXXXX, LLC provides to customers such as steel alloys.
d)
Service refers to out-sourced or subcontracted work such as machining, coating and heat
treatment.
It is the responsibility of the Purchasing Agent to perform or monitor purchasing according to these
procedures. The Purchasing Agent may appoint qualified personnel to perform these activities.
Purchasing documents are prepared by the Purchasing Agent and are reviewed and approved by
the Purchasing Authority (Operations Manager) prior to release. A copy of the Purchase Order will
be filed in the job packet.
Purchasing documents shall clearly and completely describe the ordered products, services including,
where applicable, a precise identification, including name, part number, revision level, type, class,
style, grade, serial number, etc. and specify the necessary requirements for material as required in
the “Planning of Product Realization” section of these procedures.
The Purchasing Agent shall fax or email the purchase order, with supporting documentation, to the
supplier, as applicable. In the event the purchases are to be verified at the supplier’s premises,
verification arrangements and the method of product release shall be stipulated in the purchasing
documents
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-5.6.2.3
SHEET: 2 OF 6
PURCHASING
Only approved suppliers as described in the “Supplier Evaluation, Approval and Reevaluation”
section of these procedures are made available for creating Purchase Orders (POs).
Obtain approval for the purchase of new types of equipment, products or material as required in the
“Management of Change” section of these procedures. Obtain a minimum of two quotes whenever
practical.
Provide shipping instructions or reference to standard shipping instructions of which the vendor has
been made aware.
Reference all necessary, standards, specifications (including acceptance criteria) and
customer/industry/legal requirements (including those for personnel). Furnish the specifications if the
supplier/vendor doesn’t already have them.
Obtain approval by authorized personnel to ensure adequacy of purchasing documents prior to their
communication to the supplier.
Order complete documentation packages for the purchase of products or materials and a Certificate
of Compliance (CoC) as a minimum for services.
Additional Requirements for Raw Material
PROCUREMENT OF MATERIAL MANUFACTURED IN CHINA IS PROHIBITED!!!
a)
Procure from only approved manufacturers and/or processors. Materials originating from an
approved manufacturer and/or processor but marketed by a distributor shall be considered as
having been purchased from the approved manufacturer and/or processor.
b)
All raw materials are required to meet or exceed applicable API, industry, and XXXXXXXX,
LLC specifications. This shall be verified by material quality audits or receiving inspections,
based upon the discretion of XXXXXXXX, LLC.
c)
Provide any special test or inspection requirements which must be met by the vendor prior to
material delivery.
d)
Review the Material Test Reports (MTRs) prior to issuance of the PO whenever practical.
Verification of Purchases
Procurement, QC, Receiving and Inventory personnel are responsible for the verification of purchases
when received. These control features verify that purchases conform to the requirements specified on
purchase orders.
Match the description and quantities with the PO and ensure that the associated documents are
traceable to the product, material or service. Check the PO against the material requirements listed on
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PURCHASING
SECTION: QP-5.6.2.3
SHEET: 3 OF 6
the Job Traveler and customer drawing when applicable and bring any discrepancies to the QHSE
Manager or Purchasing Agent.
Hold the PO of partial deliveries until the remainder of the order is complete. Handle the remaining
material accordingly upon receipt.
Identify material for traceability purposes as required in the “Identification and Traceability” section
of these procedures.
Perform the following upon receipt of each shipment of material.
Raw Stock
a)
Review the MTRs to verify the test report to material specifications.
b)
Perform a dimensional check of the length, outside diameter, and inside diameter to verify
accuracy. Measure trepanned material to confirm concentricity.
c)
Approve acceptable documents confirming that the material meets the specifications on the
PO.
d)
Forward the documents to the QHSE Manager and/or place the approved and stamped MTR in
Router.
e)
Release acceptable items into inventory.
f)
Receiving Agent completes the receiving log and the signs off on the traceability form.
g)
Attachment #1 is a flowchart indicating the proper reception of raw stock.
Forged or Casted Parts
a)
Match the incoming material description with the PO and ensure that the documents are
traceable to the material.
b)
Review the MTRs to verify the test report to material specifications.
c)
Examine for the following:

Under fill – Defect on the casting caused by mold not filling completely.

Pit – A surface depression formed during casting.

Crack – An inclusion on the surface, which may carry through the casting.

Function test cages with a canister and ball before released to inventory.
d)
Approve acceptable documents confirming that the material meets the specifications on the
PO.
e)
Release acceptable items into inventory.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PURCHASING
f)
SECTION: QP-5.6.2.3
SHEET: 4 OF 6
Receiving Agent completes the receiving log and the signs offon the traceability form.
g)
Forward the documents to the QHSE Manager and/or place the approved and stamped MTR in
Router.
Non-Machining Special Process such as Heat Treated or Coated Parts
a)
Visually inspect parts for defects (scratches, dings, etc.) and measure a random sample for
accuracy.
b)
Approve acceptable documents confirming that the material meets the specifications on the
PO.
c)
Release acceptable items into inventory.
d)
Receiving Agent completes the receiving log and the signs off on the traceability form.
e)
Forward the documents to the QHSE Manager and/or place the documents in Router.
Machining Services
a)
Forward the products to the QC area.
b)
Process the products as required in the “Inspection” and “Testing” sections of these procedures.
c)
Quality Inspector completes the receiving log and the signs off on the traceability form.
d)
Forward the documents to the QHSE Manager and/or place the inspection reports in Router.
Inspection Services
a)
Review reports for accuracy.
b)
Includes all documents in the Router.
Customer Supplied and/or Water-jet/Flame-cut Material
a)
Forward the products to the QC area.
b)
Process the products as required in the “Inspection” and “Testing” sections of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PURCHASING
SECTION: QP-5.6.2.3
SHEET: 5 OF 6
c)
Quality Inspector completes the receiving log and the signs off on the traceability form.
d)
Forward the documents to the QHSE Manager and/or place the inspection reports in Router.
Nonconformance
Return materials that do not meet the specifications to the vendor after documenting the
discrepancy traceable to that vendor.
Discrepant Customer Supplied product (notably prefabricated or water cut/flame cut/plasma cut
material) shall be processed in the same manner as discrepant purchases as required in the “Control
of Nonconforming Products” section of these procedures.
Repeated nonconforming shipments by a single vendor shall be cause to audit such vendor or remove
that vendor from the approved vendors list as required in the “Supplier Evaluation, Approval and
Reevaluation” section of these procedures.
Process discrepant purchases as required in the “Control of Nonconforming Products” section of these
procedures.
Handle and store acceptable products as required in the “Preservation of Products” section of these
procedures.
Retain records as required in the “Control of Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PURCHASING
SECTION: QP-5.6.2.3
SHEET: 6 OF 6
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRODUCTION PROVISION
1.
SECTION: QP-5.7.1.1
SHEET: 1 OF 5
Purpose
This procedure describes methods to assure that production requirements are controlled in
accordance with the XXXXXXXX, LLC Quality Management System (QMS) and applicable API
requirements.
2.
Scope
To provide a production process for XXXXXXXX, LLC at all manufacturing facilities.
3.
Procedure
The Manufacturing and QC departments are responsible to ensure adherence of these procedures.
Provide the necessary resources and information for producing the products as required in the “Work
Environment” section of the Quality Manual and the “Documentation Requirements” section in these
procedures.
Develop and implement quality plans for specific customers as required in the contract(s).
Communicate the plans to relevant personnel.
The following processes are provided as a general flow of tasks and should be adhered when
practical.
TABLE OF CONTENTS
PROCESS
JOB TRAVELER/ROUTER
MATERIAL SELECTION
MATERIAL SAWING
MATERIAL RE-MARKING
LATHE PROCESS
MILLING PROCESS
DEBURRING, POLISHING AND
CLEANING PROCESS
SECTION
1
2
3
4
5
6
7
1.
Job Traveler/Router Work Order Packets
a)
Generate machining work order packets which are verified as described below.



Uniqueness of work order number
Correctness of part number and part description
Material description and availability of material specified
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRODUCTION PROVISION




SECTION: QP-5.7.1.1
SHEET: 2 OF 5
Validity of outlined processing procedures
Proper authorization and review
General form completeness
That the part number and revision listed on the work order matches the part number listed
on the customer supplied drawing/print and customer purchase order
Work order verification shall be conducted by the Operations Manager or his designee and shall be
designated as verified by giving the Router/Job Traveler to the QHSE Manager for the generation of
QCR’s (dimension worksheet quality control inspection reports) and “bubbling” of dimensions on the
customer drawing.
Job Travelers will be placed in the appropriate “Waiting on Material” bin (AIT Purchase Orders,
Customer Supplied Material, or Special Process).
Receiving agent retrieves traveler when performing receiving inspection. Upon approval of all
product ordered, the destination of stock material is written on the Traceability form. The Work
Order is released to manufacturing by signing off on “Received By” section of traceability form and
placed in the Operations Manager’s office.
Expediting work orders before verification is completed shall be permitted only for each step
approved and initialed by the Operations Manager, Foreman or Quality Manager.
The work order may be altered if minor discrepancies are noted by using “white out” and written
over by the person reviewing the work orders. Drawing a single line through the error discrepancy
and writing the correction afterwards is also acceptable. That person can then duplicate his or her
alterations in whichever database corresponding to the incorrect information. Initial and Date next
to alterations.
The work order shall be returned to the originator if major discrepancies are noted with a
memorandum specifying the discrepancies and requesting clarification thereof.
The verification process shall start anew upon the reissuing of any returned work order.
2.
Material Selection
a)
Retrieve raw stock from the receiving/holding area.
b)
Correlate the XXXXXXXX, LLC unique Work Order Number, Heat number and/or Purchase
Order number (where applicable) that is written the raw stock with the unique Work Order
Number and Heat/PO/Customer ID numbers found in the router.
3.
Material Sawing (if applicable)
a)
Cut material to the length specified on the Job Traveler sawing process or on the Saw/Rough
Turn drawing.
PRODUCTION PROVISION
SECTION: QP-5.7.1.1
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SHEET: 3 OF 5
b) Maintain material identification on cut product AND “drop” as required in the “Identification
and Traceability” section of these procedures.
c)
Proceed with cutting lot, as per work order packet.
d)
Record drop size (if any) on traceability form, along with QTY and size of saw cut stock.
e)
Place processed parts in an appropriate routing container.

Include the work order packet.
f)
Route as per work order requirements.
4.
Material Re-marking
a)
Re-mark material whenever a process removes the required traceability.
b)
Place the number on each end of the material.
c)
Tag the material of container with required traceability if material size/configuration does not
permit number application.
d)
Place parts in an appropriate routing container if part configuration does not permit number
application.

Routing container or pallet must possess the material number for that approved work
order.
5.
Lathe Process (If Applicable)
a)
Load the machine program.
b)
Set and qualify


Appropriate tools.
Appropriate chuck jaw parameters.
c)
Run the machine program and record name, machine #, operation # and start date on
Traceability Form
d)
Re-mark material as required in the “Identification and Traceability” section of these
procedures.
e)
Perform first article inspection as required in the “Inspection” and “Testing” sections of these
procedures.
f)
De-bur all rough areas as result of machining process.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRODUCTION PROVISION
g)
SECTION: QP-5.7.1.1
SHEET: 4 OF 5
Place processed parts in appropriate routing container and write the run number on each
piece sequentially in the order the process was machined.

Lot inspection is performed and documented by the operator. Include work order packet.
h)
Record operation end date and destination on Traceability and route as per work order
requirements.
6.
Milling Process (If Applicable)
a)
Load machine program.
b)
Select and qualify

Appropriate tooling.

Appropriate fixture.
c)
Run machining process and record name, machine #, operation # and start date on
Traceability Form.
d)
Re-mark material as required in the “Identification and Traceability” section of these
procedures.
e)
Perform first article inspection as required in the “Inspection” and “Testing” sections of these
procedures.
f)
De-bur all rough areas as result of machining process.
g)
Place processed parts in appropriate routing container and write the run number on each
piece sequentially in the order the process was machined.

Lot inspection is performed and documented by the operator. Include work order packet.
h)
Record operation end date and destination on Traceability and route as per work order
requirements.
7.
De-burring, Polishing, and Cleaning Process (If Applicable)
a)
Review quality approved work order process sheet.
b)
Select appropriate tooling and fixtures.
c)
Perform the process.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRODUCTION PROVISION
SECTION: QP-5.7.1.1
SHEET: 5 OF 5
d)
Re-mark material as required in the “Identification and Traceability” section of these
procedures.
e)
Place parts in appropriate routing container or on a pallet. Include work order packet.
f)
Route as per work order requirements.
Product Release
The Facility Manager, QHSE Manager or his designated personnel are responsible for final release of
product for delivery. Product that has passed the final inspection will be placed in the shipping area
with a delivery ticket and released for shipment (via the traceability form) to the Customer.
Review documents and records as required in the “Documentation Requirements” and “Control of
Records” sections of these procedures for adherence throughout the production process. Verify that
all procedures were completed as required in the planned arrangements as required in the “Planning
and Communication” and “Inspection” sections of these procedures. (The router/Job Traveler and Job
Boss software contains much of the information.)
Maintain records as required in the “Control of Records” section of these procedures that identify the
individual releasing the product(s).
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SERVICING PROVISION
1.
SECTION: QP-5.7.1.2
SHEET: 1 OF 1
PURPOSE
To prescribe the procedure to be followed by XXXXXXXX, LLC to assure that customer supplied
material is controlled and servicing and/or repairs of product are conducted in accordance with the
XXXXXXXX, LLC Quality Management System (QMS) and any applicable API requirements.
2.
APPLICATION
This procedure shall be followed in any location where XXXXXXXX, LLC performs services to products.
The procedure is applicable for any customer owned products or materials entering an XXXXXXXX,
LLC facility.
3.
PROCEDURE
XXXXXXXX, LLC. does not perform field servicing after product has shipped to
Customer. This element of the API Q1 Spec does not apply to XXXXXXXX, LLC at this
time.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
VALIDATION OF PROCESSES FOR
PRODUCTION & SERVICING
1.
SECTION: QP-5.7.1.5
SHEET: 1 OF 2
PURPOSE
To describe validation processes for subcontracted services which are incapable of being verified by
monitoring or measurement after the services are performed.
2.
SCOPE
This requirement is applicable for all XXXXXXXX, LLC subcontractors performing these special
processes or services. Special processes that may be used by XXXXXXXX, LLC are welding, NDE, Shot
Peen/bead blasting, Heat Treatment, EDM, UT Testing, and Coating.
3.
PROCEDURE
The QHSE Manager is responsible for identifying special processes used in operations and for
prescribing methods and procedures for performing, controlling, and if required, recording such
processes. All training and qualification records and procedures used for any special processes, when
required, shall be filed in Document Control center.
XXXXXXXX manufactures only Customer product—if any special process is required and the customer
does not provide a specification for that special process, the customer will be contacted to verify
whether or not they have a specification they prefer. If not, AIT will present an Industry Standard for
that special process to the Customer for review/approval before subcontracting occurs.
XXXXXXXX, LLC will ask the Customer if they have a vendor preference for special processes during
Contract Review.
Purchasing, Receiving and QC personnel are responsible to ensure these procedures are adhered.
If Customer has no preference, select suppliers for these services as required in the “Supplier
Evaluation, Approval, and Reevaluation” section of these procedures.
Purchase the services as required in the “Purchasing” section of these procedures.
Customer specifications shall be followed and sent to the subcontractor as per the “Purchasing”
section of these procedures.
Receiving Inspector shall forward the product and documentation to QC.
QC Inspector shall review all documentation (such as calibration records, chart recordings, test
reports, examination records, procedures followed) to ascertain that the requirements of the
customer (or industry) specification were listed and followed on the Vendor’s report.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
VALIDATION OF PROCESSES FOR
PRODUCTION & SERVICING
SECTION: QP-5.7.1.5
SHEET: 2 OF 2
Special process vendors are required to provide a signed and dated QC report (or fill out the
XXXXXXXX provided QCR) for those processes which complete dimensions on the print (i.e. – EDM)
with all relevant job information and part S/Ns corresponding to their measurement.
Review documents and records as required in the “Documentation Requirements” and “Control of
Records” sections of these procedures for adherence throughout the production process. Maintain
records as required in the “Control of Records” section of these procedures that identify the individual
releasing the product(s).
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IDENTIFICATION & TRACEABILITY
1.
SECTION: QP-5.7.3.0
SHEET: 1 OF 4
Purpose
To describe the procedure to assure that raw materials and records are properly identified for
traceability to the final product in accordance with the XXXXXXXX, LLC Quality Management System
and applicable API requirements.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC procures raw materials which
will become any part of the composition of finished product.
3.
Procedure
A unique work order number will be issued through Contract Review (QP-5.1.2.3) and shall be the
primary number used for identification and traceability of raw material and/or product used for
production of Customer products.
The work order number is traceable throughout the process on all finished products and
corresponding paperwork. The work order/Job Traveler contains the following:
•
Serial Number(s)
•
Description
•
P.O. Number from Client
•
Process Routing and Approval/Date
When required, raw material, bar stock, sheet stock, extrusions, castings, or forgings are identified to
the proper certification and are stored in an area apart from the normal flow of
in-process material.
•
Copies of all certifications are filed and are available for review at the Customer's request.
•
Only raw material accepted by the Receiving Agent is released for production use
•
Certified stock is issued from the raw material storage area.
•
All certifications will be identifiable to the applicable purchase order, date of receipt of the
material and the inspector. In most cases, this is accomplished by stamping, signing, and dating.
Quality records shall be stored and maintained as required in the “Control of Records”, “Inspection”,
& “Testing” sections of these procedures.
Responsibility
The QHSE Manager is responsible for all identification and traceability.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IDENTIFICATION & TRACEABILITY
SECTION: QP-5.7.3.0
SHEET: 2 OF 4
The Receiving Agent shall be responsible application of AIT WO# at a minimum, and if applicable
the AIT PO#, Heat #, and material reference numbers to raw material.
Machine operators are responsible for replacing markings or verifying that markings remain
following a process.
Incoming Raw Material and Application of AIT WO Number
Apply the unique AIT Work Order number to every piece of raw stock which preserves traceability to
any and all applicable Material Test Reports (MTR) regarding that particular material. Bar stock
longer than 24” will have traceability applied on each end.
Apply the Heat # traceable to applicable MTR’s, along with Purchase Order # the material was
ordered under. This information may already be written on the part by the vendor; it can be found
on the delivery ticket, MTR, and router. Some materials, such as plastics and certain grades of
aluminum may not have an MTR or Heat #.
When raw material purchased by XXXXXXXX is received without an MTR, the QHSE Manager shall be
notified to determine if such documentation and (Heat) traceability is required.
After the product has been received/accepted according to the “Purchasing” & “Inspection” sections of
these procedures, fill out the “Received By” section of the traceability form (AITM-023), recording
Heat#(s) if applicable. Forward all documentation & MTR’s to the QHSE Manager or place in the
router/job traveler. If raw material for a given AIT WO has multiple heat numbers, ensure the Job
Traveler and Traceability form are stamped with the “Multiple Heat Numbers” stamp.
Traceability of Customer Supplied Material or Products
Customer supplied material, after receiving approval as described in the “Inspection” section of these
procedures, shall be marked with the corresponding AIT WO# (at a minimum) and any customer
supplied identification numbers (i.e. – A# or B#) if applicable.
All accompanying documentation shall be forwarded to the QHSE Manager and/or placed in the
router/job traveler. Customer ID#’s or Customer traceability #’s and/or Heat #’s shall be written in
the “Received By” section of AIT’s traceability form.
If customer supplied material does not have the required traceability, the Sales Manager shall be
informed and obtain required customer traceability/ID information and communicate to the
Receiving agent for marking.
Sometimes, customers deliver material for future jobs BEFORE contract review and planning have
occurred. In these instances, the product will be segregated and labeled with the customer’s name
until proper traceability is determined and applied.
All Customer supplied stock or material shall be segregated by customer, apart from AIT purchased
stock, until product realization begins. The pallet or rack the stock is stored on will have an index
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IDENTIFICATION & TRACEABILITY
SECTION: QP-5.7.3.0
SHEET: 3 OF 4
card or placard with the customer’s name attached (in addition to the required traceability written
on the material or container).
In Process Material Marking Media
Apply traceability using markers of sufficient durability to prevent inadvertent removal. Consider
the elements to which the materials will be exposed, past experience of durability and the size or
configuration of the material when choosing the type of marker.
Paint markers and acid pens are typically adequate for marking materials that will be exposed to
outside environments for less than one year and paint pencils or permanent markers (Sharpie or
Magic Markers) are acceptable for materials not exposed to the elements.
Sawing and Remarking of Material
Re-apply the AIT work order number on each sawed piece or store the material in a container or on a
pallet (use pallet tags) that has been clearly marked with the AIT work order number. Marking each
individual piece is preferred.
If the material for any AIT Work Order has different Heat #’s, in addition to the WO#, apply the
Heat #’s to each individual sawed piece or store the material in a container or on a pallet (use pallet
tags) that has been clearly marked with the AIT WO and Heat #’s. Marking each individual piece is
preferred. If room/configuration does not allow, try to distinguish by putting H1 or H2 when two
Heat #’s are used or segregate in separate lableled containers, and make note on the router which
Heat # is designated as H1 and H2.
Mark individual pieces when more than one AIT work order is stored in the same container or on the
same pallet.
Drops and Fixtures
Mark all received product and drops that will be used for fixtures as “drops” or “fixture”. All “drops”
shall have either the WO# and/or the PO# and HT# (if applicable) maintained. Tracing the drop
back to its purchase order and MTR/Heat# is the ultimate goal, so PO# & HT# are preferable due to
the fact material is often ordered on the same PO for multiple WO’s – one bar might supply material
for 3 separate WO’s using the same material to make similar parts for a customer’s order.
In Process Traceability During Product Realization (Lathe & Mill work)
All identifying marks shall be reapplied after each process. Reapplication shall be done with a paint
marker or stenciling.
Temporary serial numbers shall be assigned to each item and/or document during process to allow
traceability to the associated job folder. All in process parts shall have at a minimum the AIT WO
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IDENTIFICATION & TRACEABILITY
SECTION: QP-5.7.3.0
SHEET: 4 OF 4
and Temporary S/N’s written on them – if parts are too small to allow for this, the container shall
have the WO # and count.
If an AIT WO consist of material with multiple heat numbers, each individual piece (or its container)
shall have the Heat # applied until the Machine Operator can “marry up” heat numbers to the
temporary s/n’s on the QCR (AITM-021). For example, it is acceptable to make a notation on both
the Traceability Form (AITM-023) and QCR “Parts 1 thru 90 are HT# xxxx, Parts 91 thru 133 are HT#
xxxy”. The other option is to take the amount of heat numbers (2 in the above example) and write
H1 or H2 on the part and QCR, while making a note on both the Traceability Form and QCR that H1 =
heat # XXXX, and H2 = XXXY.
Maintain inspection and test status as required in the “Inspection” and “Testing” sections of these
procedures.
Traceability/Engraving on Realized Product
Manufacturing shall apply name plate or identification markings on products after all work is
complete, unless the customer requires no identification. In that case, released product is cleaned of
all traceability while packaging for shipping purposes.
The finished product can be engraved, stamped, marked, or labeled as per Customer specifications
allowing traceability to the associated job folder.
If the customer provided unique numbers to be engraved that will change from part to part, Machine
Operators SHALL “marry” the finished product up with the temporary S/N’s used for the purposes of
the QCR (AITM-021). A dimension block is given so that operators can write which permanent #’s
were engraved under the dimensions for what they are temporarily calling part #1 during in-process
inspection and documentation of measurements. For example, a WO of 10 parts, temporarily called
parts 1 thru 10 may have print calling out engraving information. When the print is dimensioned in
the engraving dimension is called dimension 24 in this example. If sequential S/N’s 239 thru 248 are
required to be engraved, whichever S/N is engraved for what we temporarily called part #1 will be
written in block 24 under part #1 column. From that point forward, anyone can look at our
documentation and know the measurements recorded for what we called part #1 are the
measurements for part 243.
Nonconformance
Identify and segregate nonconforming material or products as required in the “Control of
Nonconforming Products” section of these procedures.
Maintain records traceable to products as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRODUCT INSPECTION & TEST
STATUS
1.
SECTION: QP-5.7.4.0
SHEET: 1 OF 1
PURPOSE
To describe the procedure to assure that the status of in-process products are maintained in
accordance with the XXXXXXXX, LLC Quality Management System (QMS) and applicable API
requirements.
2.
SCOPE
This procedure shall be followed in any location where XXXXXXXX, LLC manufactures products.
3.
PROCEDURE
The Production, Inventory, Manufacturing, QC and Shipping and Receiving departments are
responsible for ensuring these procedures are adhered.
Process products as required in the applicable “Production Provision” section of these procedures.
Examine and verify products as required in the “Inspection” section of these procedures.
Methods for determining the status of products include:
a)
Review travelers, routers and the Job Boss software.
b)
Visually examine products to confirm whether a process is complete.
c)
Assess the product location to determine whether a process has been completed.
d)
Verify that no nonconforming markings are present that may indicate products are
unacceptable or incomplete.
Authorized personnel route only products that are acceptable and complete as required with
planned arrangements to the process that follows.
Identify and segregate nonconforming products as required in the “Control of Nonconforming
Products” section of these procedures.
Release nonconforming products only under concession by the customer.
Maintain records as evidence that processes were complete and products are acceptable or released
under concession as required in the “Control of Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRESERVATION OF PRODUCT
1.
SECTION: QP-5.7.6.0
SHEET: 1 OF 3
PURPOSE
To describe the methods of preserving products throughout the realization process and delivery to the
final destination to ensure conformance in accordance with the XXXXXXXX, LLC Quality
Management System (QMS) and applicable API requirements.
2.
SCOPE
This procedure shall be followed in any location where XXXXXXXX, LLC controls manufacturing,
storage and delivery of products.
3. PROCEDURE
Responsibility
The QHSE Manager, Shop Supervisor and Shipping/Receiving personnel are responsible for ensuring
that products are handled properly and in accordance with this procedure in order to prevent
damage and deterioration. They are responsible for:
•
•
•
•
Product handling activities
Storage
Packaging
Preservation and delivery of products to Customer requirements
Containers
Plastic bins, wood/cardboard boxes, and pallets are provided for holding products. Damaged or
dirty containers are repaired and/or cleaned, or scrapped if beyond repair.
Equipment
Equipment used for internal transport of products are overhead cranes, trucks and forklifts, slings,
hoists and other devices so as to eliminate possibilities of dropping products and/or causing personal
injury. Immediately notify superiors when products have been subjected to any type of situation
that may have caused damage to the product. Only designated personnel may operate the
equipment. The operators are specially trained and their training records are maintained by the
Quality Department.
Protection of Products
When there is a possibility of a product being damaged from contact with abrasive or dirty surfaces,
the product is protected by banding or shrink wrapping to pallets, bubble wrap, thread protectors
and/or containers during its manufacture, storage and delivery. Some materials, by contract, may
require segregation to prevent contact with substances or other materials that can cause reaction.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRESERVATION OF PRODUCT
SECTION: QP-5.7.6.0
SHEET: 2 OF 3
Storage of Products:
Storage Areas
There are shelves and racks for inventory and a number of holding areas such as receiving,
inspection, shipping and nonconforming areas. The Manufacturing and Shipping Departments are
responsible for maintenance and control of the storage areas.
Storage areas are maintained in good condition to prevent damage or deterioration of stored
products. All products are identified and arranged in groups according to their type. Inventory of
stock and in-process product is monitored for proper marking and segregation.
Assessment of Stock
The storage areas are cleaned up on a regular basis. Stock is assessed annually for damage or
defects. The identification of products are checked, and items that do not belong are removed. A
NCR is issued when damaged, deteriorated, unidentified or displaced products are found. All nonconforming parts that are found, are to be marked red and segregated in a designated hold area.
Authorization to Receive and Issue
Only products that have passed receiving or final inspections are authorized to be stored in shipping
or holding areas. Products that have passed the receiving inspection are moved to inventory storage
areas or brought into a holding area awaiting a work process in manufacturing.
The Shop Foreman shall authorize the movement of all materials in the facility work areas which
includes dispatch of materials to and from storage areas but not including the parts room.
Packaging, Preservation & Delivery of Products:
The Shipping and Receiving Supervisor or his designee shall be responsible for meeting all of the
requirements listed in this procedure.
Packaging material and packaging are specified via the Customer contracts to comply with the
Safety Design and the Logistical Specifications. The specifications are communicated to the Shipping
Personnel in the form of work instructions. When customized packaging is required by a contract, it
is so indicated on the router and the appropriate instructions are enclosed. Use of alternative
packaging materials and methods must be authorized by the Customer.
Marking is determined by the Customer and specified on the shipping order when applicable. Pallets
and packages are clearly with their contents and quantity either with a cover page or marker.
After the final inspection, products are stored in the shipping area. When a shipping order is
received, products are retrieved from the shipping or holding areas and packaged following the final
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PRESERVATION OF PRODUCT
SECTION: QP-5.7.6.0
SHEET: 3 OF 3
inspection. Adequate storage conditions and specified packaging protects the products against
damage or deterioration at those stages. Shipping Personnel are instructed to watch for any
damaged products before packaging and take corrective action if necessary in accordance “Control
of Nonconforming Product” section of these procedures.
Whether delivery is specified by the contract or not, packaging materials and design must be suitable
for the intended means of delivery.
When delivery is required by contract, only shippers from the Approved Supplier List are used unless
specified by the Customer. Maintain records of shipping as required in the “Control of Documents”
section of these procedures.
Customer Supplied Property
Inspection and Storage
Customers are required to supply their products with data sufficient to provide the company's
inspectors with the acceptance criteria against which they will carry out the receiving inspection.
Customer supplied products are received and reviewed by the QHSE Manager or designee to insure
that the products comply with the order. Any changes are written on the purchase orders and signed
and dated.
Customer supplied products are received, inspected and tested in the same manner as other
purchased products, i.e. in accordance with “Inspection” “Control Of Non-Conforming Product”
“Testing” sections of this manual. Marking, storage, handling and maintenance of Customer supplied
products also follow the same procedures applicable to purchased products.
Special Requirements
When specified in the contract, special instructions for handling Customer supplied products are
followed. When so requested, the Customer's products shall be segregated and labeled to identify
them as the Customer's property.
Loss or Damage
Any occurrence of loss, damage, deterioration or unsuitability of Customer supplied products is
reported back to the Customer by the Facility Manager, Sales Representative, or QHSE Manager.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
INSPECTION
1.
SECTION: QP-5.7.7.2
SHEET: 1 OF 4
Purpose
To describe the methods of inspecting products to ensure conformance with requirements in
accordance with the XXXXXXXX, LLC Quality Management System (QMS) and applicable API
requirements.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC inspects products on the basis
of its Quality Procedures Manual.
3.
Procedure
The Operations Manager, Shop Foreman and QHSE Manager are responsible to ensure these
procedures are adhered. This procedure, along with all applicable prints, Customer Specifications
and API, Legal, or other regulatory specifications shall compose the criteria by which first article
inspections are conducted to determine that machine processes are correct as required.
A “QC inspector” is any competent individual as described in the “Personnel Competence” section of
these procedures that is independent of the work being performed. It is acceptable for an operator
to have his fellow operator or supervisor inspect his work in the event that quality inspectors are not
present or indisposed. The same procedures below will be applicable.
ONLY the quality department can perform final inspection and final release of product.
Use measuring devices as required in the “Control of Testing, Measuring, and Monitoring Equipment”
section of these procedures.
NOTE: For single step manufacturing processes, in-process and final inspection and testing can be
performed as one activity.
Close Tolerances
When performing inspections on close tolerance dimensions (+/-.002” or less), the dimension shall be
measured in multiple locations to ensure that the tolerance is held to uniformity, and measuring
equipment to be used shall immediately be checked for accuracy against a standard prior to use for
that dimension – even if the MTE was verified at the start of shift to ensure the MTE’s are within
acceptable tolerances. (i.e. - Calipers and O.D. Micrometer shall be checked with multiple “SPI
Individual Gage Blocks” and other standards calibrated by a 3rd party to a NIST traceable standard)
When performing inspections on close tolerance dimensions (+/- .002” or less), the Shop Foreman and
Quality Manager shall determine which MTE provides the most accurate measurement. I.E.—if a
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
INSPECTION
SECTION: QP-5.7.7.2
SHEET: 2 OF 4
critical tolerance measurement can be made with O.D. Dial Calipers or an O.D. Micrometer, an O.D.
Micrometer shall be used; if the O.D. Micrometer will not fit, a Blade Micrometer shall be used, if
neither will suffice, consult with the Foreman and QC Manager for further instruction.
Receiving Inspection
All materials, components and other supplies received that are to be incorporated into the company's
products are subject to a receiving inspection. First the received goods are counted, identified and
inspected visually; then they are moved to the Receiving Inspection Area and subjected to a more
technical and thorough inspection using measuring or test equipment when required or applicable.
Incoming material or products are not used or processed until they are inspected and verified as
conforming to specified requirements in accordance with the work order and documented
procedures.
The Receiving Agent performs the receiving inspections and assembles the delivery ticket, material
certifications, drawings, specifications, etc., for verifying material and documentation to the
purchase order.
Incoming products are 100% inspected in receiving before acceptance into production. Urgent release
of products does not apply to this facility.
As a minimum, the scope of receiving inspections comprises:

Review of delivery ticket, material certification, source inspection and test records, compliance
certificates and other such documentation delivered with the product in comparison to any
customer specification found on the Purchase Order, Job Traveler, and Print when applicable.

Visual inspection to detect any damage.

Taking measurements and testing as required by applicable work instructions or procedures.
If the material/product passes all the reviews, inspections and testing, they are identified and are
placed in the appropriate work location. The Traveler and applicable documents are prepared for
each job and will follow the products through each work process.
If the material/product does not conform or the enclosed documentation is incomplete, the QHSE
Manager initiates a nonconformance report in accordance with “Control of Nonconforming Product”
section of these procedures. A copy of the NCR is attached to the Router/Job Traveler and the
material/product is identified with a red or orange “Nonconforming” marking and/or orange tape
and moved to a designated Non-Conforming Area. The other copy of the NCR is forwarded to the
Quality Department.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
INSPECTION
SECTION: QP-5.7.7.2
SHEET: 3 OF 4
First Article Inspection
A QC inspector shall examine the first article as described below by reference to all applicable prints,
machining samples, NC programs, or other data, of each machining process which is to produce more
than three (3) identical parts.
a)
Examine all critical dimensions affecting product performance for length, distance, outside
diameter, inside diameter, threads, taper, angle, height, depth, width, surface finish, diameter
and radii.
b)
Fit and function test the machining processes using the test or sample parts when specified on
the drawings.
Perform a first article inspection on each consecutive part until a part has been produced which is
within the target range for all dimensions.
Initial or stamp the QC Dimensional record and/or traveler sheet with acceptance of the process when
a successful first article inspection is achieved for the particular work in progress.
In –process or Lot Inspection
All products will be inspected and tested as required by the work order and documented procedures.
The scope of the in-process/lot inspections is determined by the QHSE Manager, and is communicated
to each work area on the work order by Importance Level. As a minimum, the scope comprises:

Hold products until the required inspection has been completed and verified on the
Traceability Form.

Review of the work order to ascertain that all specified operations, processes and first part
inspections are signed off.

Verify that applicable documents are available and traceable to the product

Visual inspection of product to ascertain that all specified operations are complete and to
detect any visible quality problems.
Operators: By initialing or dating the “operation complete” section on the traceability form,
Operators are confirming they have inspected each dimension manufactured in that operation and
have recorded their measurements in the accompanying QCR dimensional worksheet.
Quality Inspectors: verify they have performed in-process inspections, in accordance with the
importance level by initialing the QCR next to the operator’s recordings and initials. By placing his
initials, the inspector is verifying that the dimension is in tolerance—not that he got the same exact
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
INSPECTION
SECTION: QP-5.7.7.2
SHEET: 4 OF 4
measurement.
Examine each article since the last acceptable article was recorded when
discrepancies are found. (i.e. – importance level of 3 = QC inspects every 10th part in-process)
Final Inspection
XXXXXXXX shall carry out all final inspection in accordance with the work order to complete the
evidence of conformance of the finished product to specified requirements.
Final Inspection portion of the work order verifies that all inspection and tests have been carried out
and results meet the specified requirements. The quality inspector releases product to shipping by
filling out the inspection portion of the Traceability form, putting the quantity he has released going
to the destination of “shipping”.
If a product passes all the reviews, inspections and testing, it is placed in the “Ready Area”. Product
serial numbers have been milled on to the part as per customer requirements. Parts that require no
official identification numbers have a number written with paint marker for traceability purposes
(i.e. – a work order asking for 55 parts with no s/n milled will have the numbers 1 thru 55 written on
each). If the customer requires the Q.C. report, the numbers will remain on the parts. If not, the
numbers will be cleaned off at this stage.
After final cleaning and deburring process, product is then moved to a “Shipping Holding” area for
expediting to the Customer with applicable documents.
Record
To establish a final inspection record, the Quality Manager or designee signs and dates the Work
Order/Job Traveler. The Job Traveler and Traceability Form together with other product quality
records, such as material certificates, QCR’s (dimensional worksheets) and documents established
during various inspections, are preserved and filed in Document Control by Work Order Number.
Their storage locations and retention periods are specified as required in the “Control of Records”
section of these procedures.
Nonconforming Products
If a nonconforming product is identified or quality documents are incomplete, the Quality Manager
identifies the product with a red FAILED marking or tag and prepares a NCR Report. A copy of the
report is attached to the router/traveler and the product is segregated. Further processing of the
NCR Report is explained in “Control of Nonconforming Product” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
TESTING
SECTION: QP-5.7.7.3
SHEET: 1 OF 1
(NOT APPLICABLE AT THIS TIME)
1.
Purpose
To describe the process for testing products to ensure conformance with requirements in accordance
with the XXXXXXXX, LLC Quality Management System (QMS) and applicable API requirements.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC tests products on the basis of
its Quality Procedures Manual.
3.
Procedure
Testing is currently not performed by XXXXXXXX, LLC. This
section is not applicable at this time.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
PREVENTATIVE MAINTENANCE
1.
SECTION: QP-5.7.8.0
SHEET: 1 OF 2
PURPOSE
To describe a process for maintaining equipment used in the product realization process for
compliance with the XXXXXXXX, LLC Quality Management System (QMS).
2.
SCOPE
This procedure shall be followed in any location where XXXXXXXX, LLC manufactures products on the
basis of its Quality Procedures Manual.
3.
PROCEDURE
Department managers are responsible for ensuring that preventive maintenance of equipment is
conducted in the time periods required for the specific equipment.
Perform maintenance and complete maintenance checklists for equipment that directly effects the
processing of products or services provided to customers to ensure continuing process capabilities.
Machine Maintenance (saws, lathes and mills used for machining products)
The foreman is responsible for ensuring that machine maintenance is performed and documented.
Follow Original Equipment Manufacturer (OEM) recommendations for maintenance routines and
schedules.
The foreman delegates responsibility to machine operators for the following tasks:

The frequency and amount of oil to be added to machines.

The frequency and amount of machining coolant to be added to machines.

The cleaning and general upkeep of machines.
Forklifts, Overhead Cranes, Jib Cranes
The Facility Manager is responsible for ensuring that maintenance is performed on this equipment and
documented.
Follow Original Equipment Manufacturer (OEM) recommendations for maintenance routines and
schedules.
The foreman delegates responsibility to equipment operators for cleaning, lubricating, general
upkeep of the equipment.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
Preventative Maintenance
SECTION: QP-5.7.8.0
SHEET: 2 OF 2
Company Trucks
The Operations Manager is responsible for ensuring that maintenance is performed on all company
vehicles used for delivery of product.
Follow the Manufacturer’s recommendations for maintenance routines and schedules.
The foreman delegates the responsibility to shop hands and shipping agents for the cleaning,
lubricating, and general upkeep of the trucks.
Maintain history of equipment maintenance and repair records for all pertinent equipment as
required in the “Control of Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING, SECTION: QP-5.8.0.0
SHEET: 1 OF 7
& MONITORING EQUIPMENT
1.
Purpose
To define the equipment used for testing, measuring, and monitoring to verify that products meet
the requirements of the Quality Management System (QMS) during product realization, that require
a degree of accuracy necessary to control and maintain and to provide the control features for the
equipment.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC manufactures products.
3.
Procedure
Responsibility
The QHSE Manager or his designee is responsible for implementing and maintaining control features
for testing, measuring and monitoring equipment owned by XXXXXXXX, LLC or those used by
employees to verify that products meet specified requirements.
Calibrations/certifications shall be traceable to the National Institute of Standards and Technology
(NIST) and all calibrated/certified equipment used for quality control shall have a unique
identification number as well as some visual indicator for the user to confirm proof of accuracy.
The QHSE Manager or his designated representative(s) shall have the duty and responsibility for
surveying the calibration records at intervals that will assure timely calibration of all instruments
and detection of the necessity to shorten or lengthen calibration procedural due dates based on use
and continuing experience.
The QHSE Manager or his designee shall maintain a surveillance function that will appropriately and
in a timely manner disclose violations of the calibration control and recall procedures.
Proof of Accuracy
Select suppliers for new equipment and outsourced agencies for proof of accuracy services as required
in the “Supplier Evaluation, Approval & Reevaluation” section of these procedures.
Purchase new equipment and proof of accuracy services as required in the “Purchasing” section of
these procedures.
Verify or standardize measuring devices when necessary before first use, periodically during use,
whenever suspect measurements are encountered, whenever dropped, struck or subjected to any
situation that may compromise the accuracy of the device and again after use.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING,
& MONITORING EQUIPMENT
SECTION: QP-5.8.0.0
SHEET: 2 OF 7
Verification is the process of confirming that a device is accurate against a certified standard (when
necessary) for the intended use and/or a visual examination to ensure the device is fit for purpose.
a)
Visually examine all measuring devices before use. Confirm that steel rule and tape measure
corners are not rounded, and are not bent, broken, or otherwise damaged and the
graduations are legible.
b)
Use only devices that are capable of being verified for the application
c)
Devices require standardization, calibration or certification when verification indicates the
device is inaccurate or unfit for purpose.
Standardization is the process of setting adjustable parameters of a device against a certified
standard (when necessary) so that it measures or detects within the necessary range(s) for the
intended use.
a)
Use only devices that are capable of being standardized for the application.
b)
Devices require calibration or certification whenever standardization indicates the device is
inaccurate.
Calibration is the process of setting adjustable parameters of a device (when necessary) so that
verification or standardization is achievable within acceptable limits in accordance with industry
standards and/or manufacturer specifications using known references that are traceable to National
Institute of Standards and Technology (NIST).
a)
Calibration is necessary at designated intervals and whenever verification or standardization
cannot be achieved.
b)
Use only calibrated and subsequently verified or standardized devices.
c)
Devices require repair or disposal whenever calibration cannot be achieved.
Certification is the process of confirming that an article used for measurement or verification meets
applicable industry standards using known references that are traceable to NIST.
a)
Certification is necessary at designated intervals and whenever the equipment is dropped,
struck or subjected to any situation that may compromise the accuracy of the instrument or
when the equipment is suspected to produce inaccurate results.
b)
Use only certified equipment for the intended application.
c)
Devices require re-classification, repair or disposal whenever certification cannot be achieved.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING,
& MONITORING EQUIPMENT
SECTION: QP-5.8.0.0
SHEET: 3 OF 7
Equipment Requirements
Use only measuring and testing equipment to verify the quality of products as required in the
“Inspection” and “Testing” sections of these procedures that are assessed as appropriate, identified,
effective and secured.
a)
Select specific equipment that is appropriate for the task based on the ability to perform
sufficiently and accurate within a known degree.







Maintain the database software that contains items requiring proof of accuracy.
The database software system for tracking measuring devices lists the description of
each device, the serial number, calibration status (most recent calibration date and due
date).
Maintain, use and store equipment in suitable environments to preserve accuracy.
Avoid damage from being dropped, struck, or exposed to undue temperatures or
contaminants.
Prevent adjustments that would change the accuracy.
Store equipment in protective cases when not in use whenever possible.
Handle the equipment in a manner to avoid detriment of accuracy.
b)
The specified intervals for proof of accuracy are as required by industry standards or
manufacturer specifications and/or as defined below.
c)
The requirements for proof of accuracy may be from a manufacturer or supplier’s written
procedure.
d)
Calibration/certification all setting standards and ring and plug gauges shall be directly
traceable to the National Institute of Standards and Technology.
The following conditions are required in the calibration area.
a)
Place the equipment in the area for 24 hours before calibration/certification to allow the
temperature to equalize.
b)
Prevent deterioration by incorporating environmental controls.
c)
Clean and examine gauges before calibration/certification or storing.



Clean equipment using a solvent that is effective in removing grease, oil, dirt, and other
contaminants such as common lighter fluid.
Submerge all parts of the equipment that do not have internal working mechanisms in
the solvent and brush each free of contaminants.
Wipe other portions of the equipment with a clean cloth moistened with solvent.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
QP-5.8.0.0
CONTROL OF TESTING, MEASURING, SECTION:
SHEET: 4 OF 7
& MONITORING EQUIPMENT

Dry the equipment using a lint free cloth or allow evaporation after cleaning and apply
a light coat of mineral oil.
d)
Ensure adequate lighting in the area.
e)
Place equipment out of direct sun light to avoid unwanted heat and expansion.
f)
Store equipment in protective cases when not in use whenever possible.
g)
All damaged gages shall be turned in to the QHSE Manager who will determine whether the
gage should be repaired, calibrated/certified or scrapped.
Calibrate all MTE’s according to the MTE Calibration Schedule (AITM-054) unless the QHSE Manager
or his designated representative detect the necessity to shorten or lengthen the due dates based on
use and continuing experience. AITM-054 specifies calibration frequency and which MTE’s must be
calibrated externally only. Three categories and the frequencies as a minimum are as follows.
a)
Frequent use – every six months
b)
Moderate use – every twelve months
c)
Seldom use – every twenty-four months
Expired Calibrations/Certifications
Equipment that lacks current proof of accuracy shall not be used.
All personnel and departments using measuring and test equipment have the responsibility to insure
that equipment with an expired calibration is not used for measurement or testing.
Any instrument exhibiting an expired calibration date shall be returned to the QHSE department for
calibration prior to further use.
Identify and quarantine “out-of-service” devices using red tape, stickers, or tags indicating that the
equipment must be repaired, calibrated or certified before use.
Calibration Records
Maintain calibration/certification records as required in the “Control of Records” section of these
procedures.
Create flag reports for each measurement standard, device, and item of test equipment that requires
proof of accuracy that alert QHSE personnel of upcoming expirations.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING
& MONITORING EQUIPMENT
SECTION: QP-5.8.0.0
SHEET: 5 OF 7
The following information is stored in the database.
a)
A description of the equipment and the type.
b)
The unique serial number of the device.
c)
The location of the equipment and/or the responsible individual to which it is assigned.
d)
The proof of accuracy frequency intervals.
e)
The last proof of accuracy date.
f)
The proof of accuracy due date.
g)
The equipment type, manufacturer, model and serial number of the item.
h)
The date performed.
i)
The applicable procedure including the revision number.
j)
The actual readings acquired at specific intervals during the procedure, the acceptance criteria
and the deviation (when applicable).
k)
The standard(s) used to perform the procedure.
l)
Traceability to NIST.
m)
Maintain historical data of calibrations, documented MTE Verifications, and repairs for as long
as the device is in use and five years thereafter.
Identification
Use decals or stickers (visual indicator tags) to identify the calibration and repair status as follows.
a)
Include the last proof of accuracy date and date due.
b)
Color-codes may be used as a method of flagging certain devices for upcoming calibration
status.
c)
Include the serial number.
d)
Initial the sticker or tag.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING, SECTION: QP-5.8.0.0
SHEET: 6 OF 7
& MONITORING EQUIPMENT
Nonconformance
Verify, standardize, calibration of certify devices whenever an event occurs that places the accuracy
of the instrument in doubt, regardless of the normal calibration due date for that instrument.
Products inspected since the last valid calibration should be reevaluated when significant errors are
discovered with a device.
The Nonconforming (MTE) Equipment is then dispositioned by the QHSE Manager to assess and
document the validity of previous inspection and test results using data from the following quality
records:
 Certificates of Calibration
 MTE List
 MTE Verification Log
 Job Travelers
MTE found out of the required tolerance specification shall be reviewed by the QHSE Manager who
will notify the calibration supplier to recheck and recalibrate MTE. Description serial number and
frequency of calibration will be documented on the MTE list. Any out of tolerance conditions and
adjustments will be noted on the Certificates of Calibration.
If equipment is out of tolerance by less than 100% of the tolerance specification, the part will be
adjusted to design specifications and brought back into service as applicable. No review of
parts/materials qualified using this equipment is necessary.
If equipment is out of tolerance by 100% or more of the tolerance specification, the out of tolerance
condition is determined to be significant and may affect product integrity. An investigation will be
conducted by the Quality Team. Corrective action will be taken and the Customer notified if deemed
necessary after the investigation. Such reviews will be indicated on a CAR documenting any special
instructions or dispositions.
Equipment (MTE) Deviation
The Quality function has the authority to deviate from the calibration procedure with respect to
frequency and accuracy issues. Any deviation shall be approved by the QHSE Manager. The Request
for Deviation shall be used to document such deviations. Reason for deviation may be based on use
of equipment within a specific facility, design criteria, and/or lack of available resources or
equipment. It is not required that Manufacturing review such deviation unless required by the QHSE
Manager.
Records received from an outside source shall be signed, stamped, or attached to an accompanying
AIT Calibration Certificate by the Quality Control Representative to indicate that the certificate has
been reviewed and all applicable information is indicated on the certificate.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF TESTING, MEASURING
& MONITORING EQUIPMENT
SECTION: QP-5.8.0.0
SHEET: 7 OF 7
An example of MTE Deviation: it is acceptable to permanently mark O.D. Calipers as “for O.D. use
only” or “for I.D. use only” in the event either the O.D. ears or I.D. ears flare more than .002” apart
from each other. The non-conforming ears will be painted red, and a label shall be affixed to the
calipers and their container with the intended use.
Equipment Exempted From Calibration
Steel rulers and tape measures are not used for precise measurements and do not require calibration.
If they become illegible or damaged, they are replaced.
Angle blocks, and 1-2-3 blocks are not used for final inspection and do not require calibration. If they
are damaged, they are replaced.
Other equipment exempted from calibration such as radius gage sets and T-Mics have yellow “for
reference only” stickers attached to the gage or its container.
Maintenance of Records/Responsibilities
All measuring and test equipment calibration records are to be maintained by the Quality Control
Department and available for review by Customer Representatives.
Description of all findings and non-conformances are documented on the NCR in accordance with
“Control of Nonconforming Products” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF NONCONFORMING
PRODUCT
1.
SECTION: QP-5.10.1.5
SHEET: 1 OF 3
Purpose
To define the procedure to be followed regarding the disposition of parts and materials found to be
non-conforming.
2.
Scope
This procedure applies to all supplies, parts, and materials, which are to be used to manufacture
products that are found to be nonconforming.
3.
Procedure
Observance, Segregation and Notification of Nonconformities
All personnel are responsible for reporting a nonconforming condition.
Identify nonconforming items using tape, paint markings, or tags and segregate from the normal
flow of processes. The following colors shall be used for indentification:
a)
b)
c)
Use yellow as the preferred method to identify products that may be reworked.
Use orange as the preferred method to identify products that do not meet Manufacturing
Acceptance Criteria (MAC) and may be accepted as is.
Use red as the preferred method to identify products that may not meet the Design
Acceptance Criteria (DAC) and may be deviated, or product that will likely be scrapped.
Identify and segregate all parts made since the last acceptable inspection when the non-conformance
is discovered during in-process manufacturing.
Document non-conformance measurements on the QCR and Instances of Scrap form (if applicable).
Notify the QHSE Manager and foreman for disposition.
Disposition of Nonconforming Articles
The QHSE Manager and/or customer review the non-conformance and determine the proper
disposition. There are six possibilities for disposition of a nonconforming product. It may be:
•
Reworked
•
Scrapped
•
Accept As
•
Deviation
•
Return to supplier
•
Re-graded for alternative applications
When it is obvious that a product must be scrapped or re-graded, or when it can be repaired by a
simple process that shall have no effect on the product's quality, the QHSE Manager, together with
the Operations Manager and Customer is authorized to make a joint decision regarding the
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF NONCONFORMING
PRODUCT
SECTION: QP-5.10.1.5
SHEET: 2 OF 3
disposition of the nonconforming product. The decision is documented and authorized on the
Nonconformance Report, verified by an initial and date in the disposition section of the NCR.
Product tolerances that do not satisfy design acceptance criteria can only be changed by submitting
an Engineering Deviation Request and a NCR to Customer Engineering for evaluation and
disposition. The original design criteria can only be changed by Contract and/or Customer
Engineering as applicable.
MAC Manufacturing deviations to non API products can be accepted by verbal approval from
Customer representatives provided that these deviations do not affect the form, fit, function, or
intended use of the products. Identify the party who approves Accept AS Is disposition on the NCR
with the name and date of acceptance. Printed emails may be attached as evidence.
If a trend in non-conformances develops, the Quality Manager will generate a Corrective Action
Request to address the root cause and preventive actions taken.
Record disposition instructions shall be recorded on the report.
Notify personnel to further segregate products determined as “scrap” into the scrap area and identify
using the color red.
Provide detailed instructions for repairs of the nonconformance on the report when the disposition is
determined as “rework”.
a)
Parts awaiting rework must remain in the non-conforming or hold area and identified.
b)
Retain the nonconforming identification on the parts at all times (if possible) during rework.
c)
Schedule a reevaluation of the product following the rework.
d)
QC personnel may remove the identification once the required rework has been completed,
reevaluated and found acceptable.
Provide a disposition of “Use as is” for products that do not meet MAC but meet Design Acceptance
Criteria (DAC).
a)
QC personnel may then remove any tape or tag(s) and release the part(s).
Release of Nonconforming Product Under Concession
The QHSE Manager, Operations Manager, or his designee is responsible to obtain verbal or written
approval from the customer if there is a deviation from the purchase order.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CONTROL OF NONCONFORMING
PRODUCT
SECTION: QP-5.10.1.5
SHEET: 3 OF 3
Nonconforming Product Identified After Delivery
The Operations Manager and/or the QHSE Manager are responsible for reporting nonconforming
products discovered after delivery (field nonconformance) and create a plan of action to correct the
nonconformance.
Notify the Operations Manager and QHSE Manager immediately when a customer reports a field
nonconformance.
Investigate the risk involved due to the nonconformance as required in the “Contract Review” section
of these procedures, implement immediate corrective action as necessary, and Root Cause Analysis
(RCA) and action necessary to prevent the incident from recurrence.
Customer Notification
Notify the customer when warranted based on the results of the investigation for a field
nonconformance, when a delivered product does not conform to DAC or does not conform to the
contract.
Notify customers of a field nonconformance via email, fax, meetings, or phone conversations.
Request an acknowledgement of receipt from an authorized customer representative.
Communication with customers may also involve Sales or Quality personnel regarding a field
nonconformance.
Corrective Action
The Operations Manager and QHSE Manager are responsible for investigating non-conformances to
determine whether corrective and/or preventive action is necessary.
Implement corrective action and/or preventive action as required in the “Improvement” section of
these procedures.
Maintain records of nonconformities as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT OF CHANGE (MOC)
1.
SECTION: QP-5.11.0.0
SHEET: 1 OF 2
PURPOSE
To describe a process of managing planned and implemented changes affecting the XXXXXXXX, LLC
Quality Management System (QMS) by identifying and assessing the potential risks involving the
changes and obtaining necessary approvals for the change.
2.
SCOPE
This procedure is applicable to all XXXXXXXX, LLC facilities for changes to the QMS that could
negatively impact the quality of products.
3.
PROCEDURE
Any individual may recommend changes and initiate a MOC form. The QHSE Manager or his
designee is responsible for reviewing and routing the form to appropriate managers for
recommended changes.
Authorized managers are responsible for ensuring the MOC process is adhered. Responsibility for
authorizing the change is dependent on the change request and the department or area of the
proposed change.
Changes should be evaluated and managed to ensure that risks arising from changes remain at
acceptable levels.
Changes should also be evaluated for potential impact to Safety and Environmental Management
Systems (SEMS) covered operations to determine if the MOC process applies.
Implementation
Implement the MOC process whenever the following changes are in consideration.
a)
Substitutions of personnel (replacements), changes of essential personnel, personnel vacancies
(hiring) and additions or changes to the organizational structure.
b)
Changes of critical suppliers for potential impact on quality and delivery followed by
implementation of the “Supplier Evaluation, Approval and Reevaluation” section of these
procedures.
c)
Policy and/or Procedural changes such as changes to written documents within the QMS,
operating procedures, work instructions, quality plans and/or job descriptions.
d)
Engineering changes by the customer which are physical changes to a design or component.
e)
Recommended corrective or preventive actions resulting from the requirements in the
“Improvement” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT OF CHANGE (MOC)
SECTION: QP-5.11.0.0
SHEET: 2 OF 2
Assign a sequential number to each MOC form and maintain a log of those initialized for tracking
purposes.
a)
Review the form for detail content and obtain any additional information that may be
necessary to process the request from the initiator.
b)
Forward valid forms to the responsible manager and determine the level of approval
authority based on the type of change request and a requested target date for a response.

A “response” by the target date does not require completion of the entire process by the
date.
Review the MOC and assess risks associated with changes as required in the “Contract Review” section
of these procedures. Assess economics, feasibility, and overall justification for the change.
Submit acceptable MOC forms to the approval authority for final approval along with justification
details.
Implement the change after approval adhering to all necessary elements of the QMS and determine
the individuals that require notification.
Return copies of rejected or invalid forms and notify the initiator of reasons.
MOC Notification
Notify relevant individuals within the organization of the change along with details involving the
changes that could have impact on their interests.
Notify customers of changes that affect their products or services when required by the contract.
Retain records of the MOC process as required in the “Control of Records” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
CUSTOMER SATISFACTION
1.
SECTION: QP-6.2.1.0
SHEET: 1 OF 1
Purpose
This procedure provides a means of measuring customer satisfaction and to ensure that problems
being faced by our customers are addressed in a timely manner.
2.
Scope
This procedure applies to all feedback provided by our customers via phone, fax, or (e)mail.
3.
Procedure
Customer Complaints
The Operations Manager or his designee shall handle all customer complaints whether by phone, fax,
and/or (e)mail. Any department receiving a customer complaint shall forward the call to the
Operations Manager.
The QHSE Manager shall document the Customer Complaint upon notification of the problem by the
Operations Manager. The QHSE Manager will initiate our own internal NCR and/or CAR/PA and
attach it to the customers when the customer issues their own Non-Conformance Report (NCR).
Process field non-conformances as required in the “Control of Non-conforming Products” section of
these procedures.
Implement corrective and/or preventive actions as a result of customer complaints as required in the
“Improvement” section of these procedures.
Analyze data as required in the “Analysis of Data” for measuring customer satisfaction section of
these procedures.
Retain records of customer satisfaction as required in the “Control of Records” section of these
procedures.
The objective of improving of customer satisfaction for the time period being audited shall be
reviewed, counted and the results presented as required in the “Management Review” section of
these procedures.
Customer Surveys and other Positive Feedback
Customer Surveys shall be sent out annually or as needed by the Operations Manager or Sales
Manager. Transcribing phone conversations, text exchanges, or minutes of meetings with the
customer is also an acceptable method. Email correspondence may be printed. All transcribed
feedback notes from phone conversations, meetings, or texts with the customer will have the date,
customer representative’s name, and AIT Representatives signature.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-6.2.3.3
SHEET: 1 OF 2
INTERNAL AUDITS
1.
Purpose
This procedure defines the responsibilities, methods and means for conducting audits to verify that
the XXXXXXXX, LLC Quality Management System (QMS) is effectively implemented and maintained.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC manufactures or services
products.
3.
Procedure
The QHSE Manager or his designee is responsible to ensure that audits are performed as required in
this procedure.
Assign auditors that are competent as required in the “Personnel Competence” section of these
procedures and independent of the area being audited.
Create an audit schedule annually with an objective to verify compliance of each QMS element every
twelve months as a minimum.
a)
Schedule more frequent audits of critical processes and those with findings, concerns or a
nonconformance discovered from previous audits.
b)
Include outsourced activities by suppliers providing critical products as described in the
“Supplier Evaluation, Approval and Reevaluation” section of these procedures.
Audit Plan
Prepare an audit plan using the Internal Quality Assurance Audit Plan and Report as a guide and/or
check list.
Include the following in the Audit Plan:
a)
A unique number assigned to reference the particular plan and report.
b)
The name of the program or project to be audited.
c)
The planned audit date.
d)
Detailed description of the audit procedure to be followed.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-6.2.3.3
SHEET: 2 OF 2
INTERNAL AUDITS
e)
The signature or unique stamp of the person who has prepared the plan.
f)
Product specification requirements involving relevant processes.
Obtain approval of the Audit Plan from the Operations Manager.
Audit Report
Generate a report following the audit containing the following information as a minimum:
a)
The name of the person contacted for each area of the audit.
b)
The actual date of the audit.
c)
Detailed audit findings.
d)
Corrective Actions issued as a result.
e)
Objective evidence that the QMS is implemented and maintained.
Nonconformance
Address any nonconformance by the target dates as required in the “Improvement” section of these
procedures.
Records
Retain completed audit forms, reports, and any other records from the audit as required in the
“Control of Records” section of these procedures.
Review audit results as required in the “Management Review” section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
ANALYSIS OF DATA
1.
SECTION: QP-6.3.0.0
SHEET: 1 OF 2
Purpose
The purpose of this procedure is to establish analytical methods for measuring the suitability and
effectiveness of the Quality Management System (QMS).
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC is licensed by the American
Petroleum Institute.
3.
Procedure
The QHSE Manager or his designee is responsible for collecting, analyzing and summarizing the data
accumulated as required in the “Quality Objectives” section of these procedures.
Identify, analyze and summarize Key Performance Indicators (KPIs) and determined goals as desired
using the Data Analysis Job Log (AITM-047) and Job Boss software for reporting as required in the
“Management Review” section of these procedures.
Analyze data collected from the “Customer Satisfaction” section of these procedures.
a)
Customer communications in the form of email, fax, letter, hand/typewritten notes as well as
any other anecdotal evidence (to include positive feedback) will be used to determine
customer’s perception.
b)
Review Customer Complaints. Similarity of occurrence causing customer complaint and
frequency of occurrence causing customer complaint is collectively reviewed in order to locate
possible characteristics and trends in customer dissatisfaction.
c)
Further, the total number of Customer Complaints accumulated during the audited period will
be divided by the number of product sold during the audited time period, which will provide
the customer dissatisfaction ratio (customer complaints / total product sold = customer
dissatisfaction ratio).
d)
The reduction of Customer Complaints will result in a lower customer dissatisfaction ratio,
which would be evidence of improved customer service, and vice versa.
Analyze data for measuring reduction of non-conformance as follows:
a)
Review the Conformance Correction Reports. Similarities of occurrence causing nonconformance, frequency of occurrence causing non-conformance, similarity of occurrence
causing non-conformance regarding individual operators, and frequency of occurrence
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
ANALYSIS OF DATA
SECTION: QP-6.3.0.0
SHEET: 2 OF 2
causing non-conformance regarding individual operators will be collectively reviewed in order
to locate possible characteristics and trends of non-conformance in processes and products.
b)
Further, the total number of Conformance Correction Reports accumulated during the time
period being audited, once counted, shall be compared with the amount of Conformance
Correction Reports for the previous year. A reduction of Conformance Correction Reports from
the previous year being audited would be evidence of a reduction in overall non-conformance,
and vice versa.
c)
Address any identifiable characteristic and/or trend, or possible characteristic and/or trend, as
required in the “Improvement” section of these procedures.
Analyze supplier performance data as required in the “Evaluation, Approval, and Reevaluation”
section of these procedures.
Summarize and report the results from the analyzed data for the time period being audited and
present the outcome as required in the “Management Review” section of these procedures.
Summarize output as required from the “Management Review” section of these procedures for
continual improvement opportunities of QMS suitability and effectiveness.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
SECTION: QP-6.4.0.0
SHEET: 1 OF 3
IMPROVEMENT
1.
Purpose
This procedure provides methods of continually improving the effectiveness of the XXXXXXXX, LLC
Quality Management System (QMS) through the use of various elements of the QMS.
2.
Scope
This procedure shall be used to address existing problems associated with customer complaints,
vendor complaints, Returned Material Authorization (RMA), or recurring problems reported during
the management review process or operational processing and is applicable for all XXXXXXXX, LLC
facilities.
3.
Procedure
Corrective Action
Any individual may initiate a corrective action request. The QHSE Manager and the affected
department manager are responsible to evaluate the request and determine when corrective action is
required.
Using AITM-014 (Corrective Action Request), describe the unsatisfactory condition and explain how it
affects quality. Forward the request to QHSE Manager for review, content, validity and processing.
a)
Corrective action may be initiated due to:











Customer complaints
Vendor nonconformance
RMA
Audit findings (internal, 3rd party, and customer)
Trends
Process failures
Product nonconformance
Surveys
System failure
Management review output
Any other condition which does not comply with the QMS or API Spec Q1
Process corrective action requests that are customer complaints and/or a field nonconformance as
required in the “Control of Nonconforming Product” section and this section of these procedures.
Enter the necessary information into the corrective action report to include:
a)
Details of the nonconformance.
b)
Immediate action to correct the issue (if any).
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IMPROVEMENT
SECTION: QP-6.4.0.0
SHEET: 2 OF 3
c)
The responsible manager.
d)
Photographs, documents, reference to procedures or specifications.
e)
A target date for responding to the corrective action request.
f)
Determine the risk involved with implementing no corrective action using the risk analysis
process described in the “Contract Review” section of these procedures.

Review and implement contingency plans as described in the “Contingency Planning”
section of these procedures when warranted and implement preventive action as
described below.
g)
The results of the investigation, the direct cause, Root Cause Analysis (RCA).
h)
A list of individuals that should receive updates of the corrective action progress.
i)
The corrective action details to reduce the risk of recurrence based on the results of the
investigation and RCA.


j)
The QHSE Manager may require a written action plan to address detected
nonconformities.
Implement preventive actions as described below when necessary.
A target date for implementation of the corrective action.

Assign a competent individual that is independent of the department responsible for
implementing the corrective action to perform a follow-up review after the target date
that verifies the corrective action was implemented and effective.
Preventive Action
Any individual may initiate a preventive action request. The QHSE Manager and the affected
department manager are responsible to evaluate the request and determine when preventive action
is required.
Using AITM-008 (Preventative Action Form), describe the potential cause for non-conformity or
undesired conditions and explain how it affects quality or safety. Forward the request to the QHSE
Manager for review, content, validity and processing.
a)
Preventive action may be initiated due to:


Management review output
Risk analysis and subsequent contingency planning
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
IMPROVEMENT










SECTION: QP-6.4.0.0
SHEET: 3 OF 3
Internal audit findings
A potential cause for product or process nonconformance
The result of corrective actions as described above
Industry standard changes
Trends
An immediate need to deviate from a procedure
To increase efficiency
Surveys
Employee, customer or supplier suggestions
Safety hazards or “near misses”
Enter the necessary information into the preventive action report to include:
a)
Details of the potential cause(s) of a potential nonconformance.
b)
Reference corrective action as described above (if any), the RCA and immediate corrective
actions.
c)
The responsible manager.
d)
Photographs, documents, reference to procedures or specifications.
e)
A target date for responding to the preventive action request.
f)
Results of the risk analysis process described in the “Contract Review” section of these
procedures and the contingency plans as described in the “Contingency Planning” section of
these procedures.
g)
A list of individuals that should receive updates of the preventive action progress.
h)
A target date for implementation of the preventive action.

i)
Assign a competent individual that is independent of the department responsible for
implementing the preventive action to perform a follow-up review after the target date
that verifies the preventive action was implemented and effective.
Develop plans for revising or eliminating the specific preventive action (or parts of it)
whenever the risk no longer justifies the need and/or whenever it is determined that the action
is not effective.
Manage changes as required in the “Management of Change” section of these procedures.
Retain records of improvement processes as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT REVIEW
1.
SECTION: QP-6.5.0.0
SHEET: 1 OF 3
Purpose
This procedure defines the responsibilities and requirements for reviewing the XXXXXXXX, LLC
Quality Management System (QMS) to evaluate suitability, adequacy and effectiveness.
2.
Scope
This procedure shall be followed in any location where XXXXXXXX, LLC manufactures or services
products.
3.
Procedure
The appointed Management Representative is responsible for ensuring that the QMS is reviewed by
Management every twelve months as a minimum as described in this procedure.
Input
Schedule a meeting to include attendance of management personnel as determined by the
Operations Manager.
Establish an agenda consisting of discussion items addressing progress on the following topics since
the previous review.
a)
Follow-up actions from previous management reviews

b)
Results of audits

c)
Provide a report on the status of the audit schedule as described in the “Internal Audits”
section of these procedures and include a summary of the resulting findings from each
element of the QMS.
Changes that could affect the quality management system

d)
Provide a summary of each action item from the previous management review and
report the results on the effectiveness (both positive and negative).
Present highlights of changes to customer and/or industry standards that may require
changes to products, processes or services that we deliver.
Customer satisfaction

Provide a summary of customer complaints as described in the “Customer Satisfaction”
section of these procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT REVIEW


e)



Provide highlights of corrective and preventive action requests and the effectiveness (or
lack of) from the action.
Quality policy

k)
Summarize supplier performance based on information from the “Supplier Evaluation,
Approval and Reevaluation” section of these procedures.
Also report significant discrepancies discovered during the verification of purchases as
required in the “Purchasing” section of these procedures.
Recommendations for improvement

j)
Report the quantity of corrective/preventive action requests assigned to each
department, the quantity pending implementation of action and the quantity closed.
Analysis of supplier performance

i)
Present a summary of risk assessments performed as described in the “Contract Review”
section of these procedures.
Also provide a generalization of any ensuing results from the risk assessment as
described in the “Contingency Planning” section of these procedures.
Status of corrective and preventive actions

h)
Present the results obtained from the “Analysis of Data” section of these procedures for
measuring the reduction of nonconformance.
Also highlight any significant nonconformance with details of corrective and preventive
action.
Results of risk assessments

g)
Provide a summary of measurement of customer satisfaction as described in the
“Analysis of Data” section of these procedures.
Also present summaries of any field nonconformance as described in the “Control of
Nonconforming Products” section of these procedures.
Process performance and product conformity

f)
SECTION: QP-6.5.0.0
SHEET: 2 OF 3
Request that all attendees review the quality policy and submit recommend changes or
suggestions for discussion during the meeting.
Quality objectives

Request that all attendees review the quality objectives and submit recommend
changes or suggestions for discussion during the meeting.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
MANAGEMENT REVIEW
SECTION: QP-6.5.0.0
SHEET: 3 OF 3
Output
Create a briefing from the meeting minutes that generalizes management perception regarding the
effectiveness of the QMS.
a)
Include details of other discussion items as follows.





Recommended changes to the QMS with details of anticipated ensuing improvements.
Decisions on outstanding issue items.
Action items and defined responsibilities for implementation.
Additional resource needs or changes to existing resources.
Improvement of products relative to customer requirements.
Obtain approval of the output briefing from top management.
Retain records of each management review as required in the “Control of Records” section of these
procedures.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014
USE OF API MONOGRAM
(NOT APPLICABLE AT THIS TIME)
1.
SECTION: QP-A.4.5.6
SHEET: 1 OF 1
Purpose
This procedure provides requirements for the serializing and marking of all API monogrammed
product XXXXXXXX, LLC is licensed to manufacture and for the removal of said monogram when
necessary.
2.
Scope
The procedure is applicable for all locations where XXXXXXXX, LLC is licensed to apply the API
monogram to API product in accordance with the corresponding API Specification (i.e. – Rotary
Shoulder Connections, API Spec. 7-1.)
3.
Procedure
XXXXXXXX, LLC does not manufacture API Specified product, nor
perform API Monogram. This element of the API Q1 Spec does not
apply to XXXXXXXX, LLC at this time.
Approved by:
Controlled Document
AITM-003, Rev. 3 – 5/03/2014