Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
Page 1 of 16
Document ID: QM-001
Revision:
AE
1. PURPOSE
This document defines the requirements, processes, structure and documentation for the
Teledyne DGO Quality Management System.
2. SCOPE
The Teledyne DGO Quality Management System has been designed and implemented for
effective management, customer satisfaction, and continual improvement. It has been
implemented to meet the requirements of ISO 9001:2008. The QMS governs the design,
development and manufacture of electrical and optical connectors, cable assemblies,
penetrators, and servo control devices used in hostile environments for military and
commercial applications, including sales, testing and technical support functions.
3. REFERENCES
•
ISO 9001-2008 International Organization for Standardization
4. Table of Contents
Section
Topic
5
6
Definitions
Process Approach Quality Management
System
Document Control
Records Control
9
Management responsibility and commitment
Quality Policy
Management Review
7
8
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
ISO 9001:2008
4.1
4.2.1, 4.2.3
4.2.4
5.1, 5.2, 5.3, 5.4.1,
5.4.2, 5.5, 5.5.1,
5.5.2, 5.5.3, 5.6,
Teledyne DGO
Document
SOP-QMS-001
Legal 02-001,
Current
Teledyne
Technologies
Approved
Retention
Schedule
QP-001
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
10
11
12
13
14
Provision of Resources
Human Resources Training
Infrastructure
Planning of product realization
Design Control
16
17
Production and Process Controls
Process Validation
15
18
19
20
21
22
23
24
25
26
27
28
QUALITY MANUAL
Purchasing Process
Identification and Traceability
Customer Property
Preservation of Product
Inspection, Measuring and Test equipment
Customer Feedback
Internal Audit
Nonconforming Product
Analysis of data
Continual Improvement
Corrective and Preventative action
Revision History
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5.6.1, 5.6.1, 5.6.2,
5.6.3
6.1
6.2.1, 6.2.2,
6.3, 6.4
7.1, 7.2
7.3.2, 7.3.3, 7.3.4,
7.3.5, 7.3.6, 7.3.7,
7.4, 7.4.1, 7.4.2,
7.4.3,
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
8.1
8.2.1
8.2.2
8.3
8.4
8.5.1
8.5.2, 8.5.3
SOP-QMS-021
SOP-QMS-020
SOP-QMS-005
SOP-SCM-006
SOP-QMS-011
WI-SCM-0005
or
SOP-QMS-011
SOP-QMS-015
SOP-QMS-019
SOP-QMS-004
SOP-QMS-002
SOP-QMS-003
5. DEFINITIONS
Unless otherwise specified, all terms used in this document are defined in ISO 9001-2008
Term
Definition
TDGO
Teledyne D G O’Brien
TOG
Teledyne Oil & Gas
Concession
a special approval that is granted to release
a nonconforming product for use or delivery
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Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
PPM
QMS
SOP
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Revision:
AE
Policy and Procedure Manual
Quality Management System
Standard Operating Procedure
6. PROCESS APPROACH
Quality System Process Approach: TDGO applies a system of processes, their interactions
and their management to ensure the ongoing control over the linkage between the
individual processes and within the system of processes. This approach emphasizes the
importance of understanding and meeting requirements, considering processes in terms of
added value, obtaining results of process performance and effectiveness, and improving
processes based on objective measurement.
Figure I. Diagram of Process-based QMS:
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Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
7. DOCUMENT CONTROL
Document Control: TDGO shall determine which documents shall be controlled and which shall
be managed. The document control process shall ensure that only the correct revision of
controlled documents are available for use and that obsolete documents are not available for
use.
To align with industry standard documentation structure, TDGO has adopted QMS SOPs as
Level 2 documents and Work Instructions as Level 3 documents. During the transition from
PPM’s to SOP’s, and PPM’s to Work Instructions, all new released documents shall adopt the
new document labels. All other documents with PPM labels shall be renamed at their next
revision. An electronic link will be established for any PPM document that has been renamed or
superseded to facilitate document user’s in locating renamed or superseded documents.
Figure 2: TDGO QMS Document Structure:
L1
Manual
Policy
L2
SOP (Standard
Operating
Procedures)
L3
PPM & WI (Work instruction)
L4
Forms & Records
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
8. RECORDS CONTROL
Records Control: Records established to provide evidence of conformity to requirements and of
the effective operation of the QMS shall be controlled. Records shall remain legible, readily
identifiable and retrievable.
Where customer requirements for records retention conflict with the Teledyne Approved
Retention Schedule, the longer retention requirement shall take precedence.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
9. MANAGEMENT RESPONSIBILITY AND COMMITMENT
Customer Focus: Top Management shall ensure that customer requirements are determined
and are met with the aim of enhancing customer satisfaction.
Quality Policy: TDGO management shall establish a quality policy that shall be communicated
and implemented across the organization to describe management’s intentions with respect to
Quality. As a part of TOG, TDGO implements the TOG Quality Policy and reviews it for adequacy
at each Management Review.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
Quality Objectives: TDGO management shall establish Quality objectives that define the specific
quality goals that the organization is committed to achieving. The Quality Objectives shall be
measurable and consistent with the Quality Policy. TDGO is provided annual Quality Objectives
Management Representative: TDGO shall appoint a management representative who has the
responsibility and authority that includes
a) Ensuring that processes needed for the QMS are established and maintained
b) Reporting on the performance of the QMS and needs for improvement
c) Ensuring the promotion of awareness of customer requirements throughout the
organization.
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Teledyne D.G.O’Brien
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QUALITY MANUAL
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Internal Communication: TDGO management shall ensure that internal communication
processes are established and that communication takes place regarding the effectiveness of the
quality management system.
Management Review: TDGO management with executive responsibility shall review the
effectiveness of the quality management system at least annually.
ISO Management Representative shall;
o Schedule and conduct management reviews
o Reports on the performance of the quality management system and any need for
improvement, to top management.
Attendees:
o All members of the general manager’s staff (top management) participate and attend
management reviews. Where a member is unable to attend, advance written notice
must be provided to the ISO Management representative and a delegate named to
participate in the review.
o Assemble and forward all required and relevant data to the Management
Representative(s) prior to the scheduled meeting for inclusion into the summary to be
presented at the Management Review.
o Complete any assigned actions resulting from the Management Review.
Management Review Inputs:
o Results of Audits
o Customer Feedback
o Process performance and product conformity
o Status of preventative and corrective actions
o Follow-up actions from previous management reviews
o Changes that could affect the quality management system
o Recommendations for improvement
o Review of Quality Policy and Quality Objectives
Management Review Outputs:
o Attendance record
o Record of the content reviewed
o Action items and a summary of decisions pertaining to:
- Quality Management System improvements
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Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
-
QUALITY MANUAL
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Document ID: QM-001
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AE
Product improvements
Resource needs
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
10. PROVISION OF RESOURCES
Provision of Resources: TDGO shall determine and provide the resources needed to implement,
maintain and continually improve the QMS and maintain its effectiveness, and to meet
regulatory and customer requirements.
11. HUMAN RESOURCES
Personnel: TDGO shall ensure that all personnel are competent, adequately trained and
equipped to correctly perform their roles and that each employee is made aware of the
relevance and importance of their activities and how they contribute to the achievement of the
quality objectives. They shall also be made aware of how product defects may occur from
improper performance of their specific jobs. Appropriate records of education, training, skills
and experience shall be maintained.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
12. INFRASTRUCTURE
Infrastructure: TDGO shall ensure that infrastructure, including buildings, workspaces, utilities,
process equipment and supporting services are sufficient to ensure conformity to product
requirements is consistently achieved.
Equipment: TDGO shall ensure that all equipment used in the manufacturing process, including
inspection and test equipment, meets specified requirements and is appropriately designed,
constructed, placed and installed to facilitate maintenance, adjustment, cleaning and use. TDGO
shall ensure that equipment maintenance schedules are established and maintained, periodic
equipment inspections are conducted and documented, and that adjustments are made
correctly as needed.
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
13. PLANNING OF PRODUCT REALIZATION
Product Realization TDGO determines the following, as appropriate:
a) Quality objectives and requirements for the product;
b) The need to establish processes and documents, and to provide resources specific to the
product;
c) Required verification, validation, monitoring, measurement, inspection and test
activities specific to the product and the criteria for product acceptance
d) Records needed to provide evidence that the realization processes and resulting
product meet requirements
The output of this planning shall be in a form suitable for the methods of the organization.
Customer Related Processes: TDGO shall define product, customer, statutory and regulatory
requirements and shall establish processes to review and understand these requirements. This
review shall be conducted prior to the organizations commitment to supply a product to the
customer and shall ensure that
a) Product requirements are defined
b) Contract or order requirements differing from those previously expressed are resolved,
and
c) The organization has the ability to meet the defined requirements
Records of the results of the review and actions arising from the review shall be maintained.
Where product requirements are changed, the organization shall ensure that relevant document
is amended and that the relevant personnel are made aware of the changed requirements.
14. DESIGN CONTROL
Design Control: TDGO shall plan and control the design and development of product to include
design and development stages, the review, verification and validation that are appropriate to
each design and development stage, and the responsibilities and authorities for design and
development.
Design Inputs: The organization shall plan and control the design and development of the
product. These inputs shall include
a) Functional and performance requirements
b) Applicable statutory and regulatory requirements
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Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
c) Where applicable, information derived from previous similar designs and
d) Other requirements essential for design and development
Design Outputs: The outputs of design and development are provided in a form that enables
verification against the design and development input and shall be approved prior to release.
These outputs shall:
a)
b)
c)
d)
Meet the input requirements for design and development
Provide appropriate information for purchasing, production and for service provision
Contain or reference product acceptance criteria, and
Specify the characteristics of the product that are essential for its safe and proper use.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
Design Review: At suitable stages, systematic reviews of design and development shall be
performed in accordance with planned arrangements. Participants in such reviews shall
include representatives of functions concerned with the design and development stage (s) being
reviewed. Records of the results of the review shall be maintained.
Design and development verification: Verification shall be performed to ensure that the design
and development outputs have satisfied the input requirements. Records of the verification and
any necessary actions shall be maintained.
Design and development validation: Validation shall be performed in accordance with planned
arrangements to ensure that the resulting product is capable of fulfilling the requirements for
the specified or known intended use or application. When practical, validation shall be
completed prior to delivery of the product. Records of the results of the validation or any
necessary actions shall be maintained.
Control of design and development changes: Design and development changes shall be
identified and records maintained.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
15. PURCHASING PROCESS
Supplier Selection and Management: TDGO shall evaluate and select potential suppliers,
contractors and consultants on the basis of their ability to meet specified requirements,
including Quality requirements. TDGO shall establish and maintain records of acceptable
suppliers, contractors and consultants in an Approved Supplier List (ASL).
Purchasing Data: TDGO shall ensure that suppliers are provided with accurate and complete
requirements, including quality requirements and that changes to these requirements are
delivered to the supplier in writing, and records of these changes shall be retained in
accordance with Records Control requirements.
Verification of purchased product: The organization shall establish and implement the
inspection or other activities necessary for ensuring that purchased product meets specified
purchase requirements.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
16. PRODUCTION AND PROCESS CONTROLS
Process Controls: TDGO shall ensure that production and service provision are conducted
under controlled conditions. Production process controls shall be established where deviations
from specifications could occur as a result of the manufacturing process. Production and
process controls shall be defined in procedures and in product specific control plans as
appropriate.
Production and Process Changes: TDGO shall ensure that process changes are reviewed,
approved and verified or validated, as appropriate, prior to implementation.
17. PROCESS VALIDATION
Validation Documentation: Where the results of a process cannot be fully verified by
subsequent inspection and test, TDGO shall ensure that the process be validated with a high
degree of assurance. Process validations shall be conducted according to documented and
approved procedures, validation protocols and reports and performed by qualified individuals.
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Teledyne D.G.O’Brien
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QUALITY MANUAL
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AE
Process Control Data: TDGO shall ensure that validated processes are monitored and controlled
to ensure requirements are consistently met on an ongoing basis. The data collected as a result
of ongoing monitoring shall be documented.
Revalidation: TDGO shall ensure that when changes or process deviations occur that processes
are reviewed and evaluated and where appropriate, revalidation is performed and documented.
18. IDENTIFICATION AND TRACEABILITY
Identification: TDGO shall ensure that product is identified by suitable means throughout all
stages of receipt, production, distribution and installation to prevent mix-ups. Teledyne shall
also ensure that product status is maintained throughout all stages to ensure that all product
that has passed the required inspections and tests are accepted and released.
Traceability: TDGO, directly or through its suppliers, contractors and service providers, shall
establish, document, and maintain procedures for identifying each unit, lot, or batch of finished
products and components, where appropriate, with a unique control number. These controls
shall be used to facilitate corrective action when and if required.
19. CUSTOMER PROPERTY
Customer Property: TDGO shall exercise care with customer property, including intellectual
property, while it is under the control of the organization or being used by the organization. The
organization shall identify, verify, protect and safeguard customer property provided for use or
incorporation into the product. If any customer property is lost, damaged or otherwise found to
be unsuitable for use, the organization shall report this to the customer and maintain records.
20. PRESERVATION OF PRODUCT
TDGO shall preserve the product (and any components) during processing and delivery to the
intended destination in order to maintain conformity to requirements. As applicable,
preservation shall include:
o Identification
o Handling
o Packaging
o Storage
o Protection
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Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
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QUALITY MANUAL
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Document ID: QM-001
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AE
21. INSPECTION, MEASURING AND TEST EQUIPMENT
TDGO shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring equipment needed to provide evidence of conformity of product to determined
requirements.
Where necessary to ensure valid results, measuring equipment shall:
o
o
o
o
o
Be safeguarded from adjustments that would invalidate the measurement result.
Be adjusted or readjusted as necessary
Be identified to enable calibration status to be determined
Be protected from damage and deterioration during handling, maintenance and storage
Evaluated for impact to finished product quality where equipment is found to be out of
tolerance
Calibration records shall be maintained.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
22. CUSTOMER FEEDBACK AND COMPLAINTS
TDGO shall establish methods for communicating with customers in relation to:
a) Product information
b) Enquiries, contracts or order handling, including amendments and
c) Customer feedback, including customer complaints.
23. INTERNAL AUDIT
Internal Audit: TDGO shall conduct internal audits to determine whether the QMS:
a) Conforms to the requirements of ISO 9001 and to the established quality system and
external requirements,
b) Is effectively implemented and maintained.
The audit schedule shall be defined by the designated Quality Audit Leader. The schedule shall
be planned taking into consideration the status and importance of the processes and areas to be
audited, as well as the results of previous audits. The audit criteria, scope, frequency and
methods shall be defined. Audits shall be conducted by trained auditors who are independent of
the work being audited.
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Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
Audit Documentation: Audit reports are company confidential. Additional audit records that
provide objective evidence of audit execution shall be maintained and available for outside
review as needed.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
24. NONCONFORMING PRODUCT
Nonconforming product includes nonconforming product occurring in TDGO’s own facilities as
well as nonconforming product received or delivered by the organization.
TDGO shall ensure that product that is nonconforming or is suspected of being nonconforming
is identified, and controlled to prevent its unintended use or delivery.
TDGO shall ensure that procedures are established for review and disposition of
nonconforming product and that responsibility and authority for disposition is defined within
these procedures.
TDGO shall also ensure that actions are taken to identify, document and eliminate the root
cause of nonconforming product.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
25. MEASUREMENT AND ANALYSIS:
TDGO shall collect and analyze appropriate data to demonstrate the suitability and
effectiveness of the QMS, process and product quality to evaluate if improvements are needed.
This shall include data generated as a result of monitoring and measurement and from other
relevant sources. The analysis of data shall provide information relating to:
a) Customer satisfaction
b) Conformity to product requirements
c) Characteristics and trends of processes and products, including opportunities for
preventive action
d) Suppliers
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
26. CONTINUAL IMPROVEMENT
TDGO shall continually improve the effectiveness of the QMS through the use of:
a)
b)
c)
d)
e)
f)
g)
Quality Policy
Quality Objectives
Audit results
Analysis of data
Corrective and Preventive Actions
Management Review
Quest for Excellence Teams utilizing continuous improvement tools and techniques
27. CORRECTIVE AND PREVENTIVE ACTION
TDGO shall ensure that action is taken to identify, correct and ensure that nonconformities that
have already occurred do not recur, and to prevent potential nonconformities. CAPA
investigations shall focus on the cause of nonconformities (or potential nonconformities)
relating to product, processes or the QMS. A summary of CAPA activity shall be included in
Management Reviews.
These requirements and process are further defined in the document(s) listed for this section in the
Table of Contents.
28. REVISION HISTORY
Revision G Released 10/01/03 Per ECO 20250 Revised to meet the new requirements of ISO
9001 revision 2000.
Revision H Released 12/12/03 Per ECO 20372 Revised to change procedure numbers into PPM
numbers.
Revision J Released 03/11/05 Per ECO 21194 Revised to correct administrative errors.
Revision K Released 06/06/08 Per ECO 36950 to change logo to Teledyne logo; changed job
title; deleted reference to QATM.
Revision L Released 06/19/08 Per ECO 37010 Added servo control devices to scope.
Revision M Released 02/04/09 per ECO 37745 Changes per Management Review
Recommendation.
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
QUALITY MANUAL
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Document ID: QM-001
Revision:
AE
Revision N Released 09/21/09 Per ECO 38177 to reflect ISO 9001:2008.
Revision P Released 04/22/11 Per ECO 40901 to reflect current titles.
Revision R Released 01/08/14 Per E3476 to reflect current titles and removal of address.
Revision T Released 04/21/14 per E4019 Total Re-Write of Manual.
Revision V Released 05/12/14 Per E4053 to Include Customer – Specific Record Retention
guidance.
Revision W Released 05/30/14 per E4174 Legal Requirements for DGO.com
Revision Y Released 07/15/14 Per E4388 Multiple Changes
Revision AA Released 9/24/15 Per E4554 Clarification of Section 7
Revision AB Released 10/08/15 Per E6025 Updated references in section 4
Revision AC Released 12/15/15 Per E6801 Added Figure 1 to section 6, updated verbiage in
section 9
Revision AD Released 01/26/16 Per E6954 Added dates to revision history
Revision AE Released 03/07/16 Per E7179 Added “And Quality Objectives” to Management
Review inputs
©Teledyne Oil & Gas 2016
Teledyne proprietary. For reference only. All rights reserved.
QUALITY MANUAL
Teledyne D.G.O’Brien
162 Corporate Drive, Suite 100
Portsmouth, NH 03801-6815 US
Revision
Author
Y
K. Peek
AC
K. Peek
AA
AB
AD
AE
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AE
Sections Affected
Reason for Revision
K. Peek
K. Peek
References, Document
control and Definitions
Section 7
Section 4
K. Peek
Section 28
Updates to change to new
document system
Clarification of Section
Update documentation references
Added figure 1 to section 6, update
verbiage in section 9
Updated dates on revision table
K. Peek
Section 6 and 9
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Teledyne proprietary. For reference only. All rights reserved.
Section 9
“And Quality Objectives” to
Management Review inputs