Quality Systems Manual
Page 1 of 15
TABLE OF CONTENTS
1.0
INTRODUCTION .............................................................................................................................................4
2.0
QUALITY POLICY ...........................................................................................................................................4
2.1
QUALITY OBJECTIVES: ............................................................................................................................5
3.0
ORGANIZATIONAL CHART...........................................................................................................................6
4.0
QUALITY MANAGEMENT SYSTEM ..............................................................................................................7
4.1
Quality System ...........................................................................................................................................7
4.2
Documentation ...........................................................................................................................................7
5.0
MANAGEMENT RESPONSIBILITY ...............................................................................................................9
5.1
Management Commitment ........................................................................................................................9
5.2
Customer Focus .........................................................................................................................................9
5.3
Quality Policy..............................................................................................................................................9
5.4
Planning ......................................................................................................................................................9
5.5
Responsibility, Authority, and Communication ......................................................................................9
5.5.1
Responsibility and Authority .................................................................................................................9
5.5.2
Management Representative ............................................................................................................. 10
5.5.3
Internal Communication ..................................................................................................................... 10
5.6
6.0
Management Review ............................................................................................................................... 10
RESOURCE MANAGEMENT ...................................................................................................................... 10
6.1
Provision of Resources .......................................................................................................................... 10
6.2
Human Resources ................................................................................................................................... 10
6.4
Work Environment .................................................................................................................................. 11
7.0
7.1
PRODUCT REALIZATION ........................................................................................................................... 11
Planning of Product Realization ............................................................................................................ 11
7.2
Customer Related Processes ................................................................................................................ 11
7.2.1
Determination of Requirements Related to the Product .................................................................... 11
7.2.2
Review of Requirements Related to the Product ............................................................................... 11
7.2.3
Customer Communication ................................................................................................................. 11
7.3
Design and Development ....................................................................................................................... 11
7.4
Purchasing ............................................................................................................................................... 11
7.5
Production and Service Provision ........................................................................................................ 12
7.5.1
Control of production and service provision....................................................................................... 12
7.5.2
Validation of processes for production and service provision ............................................................ 12
7.5.3
Identification and traceability ............................................................................................................. 12
7.5.4
Customer property ............................................................................................................................. 12
7.5.5
Preservation of product ...................................................................................................................... 12
7.6
8.0
8.1
Control of Monitoring and Measuring Devices .................................................................................... 12
MEASUREMENT, ANALYSIS AND IMPROVEMENT................................................................................. 13
General ..................................................................................................................................................... 13
8.2
Monitoring and Measurement ................................................................................................................ 13
8.2.1
Customer satisfaction ........................................................................................................................ 13
8.2.2
Internal audit ...................................................................................................................................... 13
8.2.3
Monitoring and measurement of processes ....................................................................................... 14
8.2.4
Monitoring and measurement of product ........................................................................................... 14
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8.4
Analysis of Data ...................................................................................................................................... 15
8.5
Improvement ............................................................................................................................................ 15
8.5.1
Continual Improvement ...................................................................................................................... 15
8.5.2
Corrective / Preventive Action ........................................................................................................... 15
8.5.3
Preventive Action ............................................................................................................................... 15
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1.0
INTRODUCTION
Company X has reliably provided high quality electronics manufacturing solutions to its customers since 1984.
Our objective at Company X is to continually improve our service to customers in every way that counts: Quality,
On-Time-Delivery and Cost. This is accomplished through excellence in: people, equipment, customer service
and job performance.
The quality management system at Company X encourages employee ownership and empowerment and is
supported by a strong top management commitment to quality excellence.
Quality initiatives focus on continuous improvement, process control, production support, employee training and
continuous monitoring of customer satisfaction. This quality manual provides the overall strategy and objectives
of our quality system.
Company X’s quality system is modeled after the ISO 9001:2000 quality standard and in many cases exceeds the
requirements set forth in the ISO 9001 standard.
Company X is pleased to provide the quality manual to our customers. Understandably, Company Xs processes
and procedures are considered proprietary and shall be considered confidential and used solely for the purposes
of evaluating Company X. Manuals provided to our customers are uncontrolled and will not be updated unless
specifically requested by the customer.
2.0
QUALITY POLICY
At Company X, it is our goal to:
Always:
Understand and Meet the Needs
of our Partners!
Basic Principles govern our actions:
1. Process Focus - Focus on the work process, issue or behavior, not the person
2. Mutual Respect - Maintain the self-confidence and self-esteem of others
3. Partnerships and Teamwork - Maintain strong partnerships with your internal and
external customers and suppliers
4. Personal Initiative - Take the initiative to improve work processes and partnerships
5. Leadership by Example - Lead by example
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2.1
QUALITY OBJECTIVES:
Company X has many objectives that it uses to gauge the health of the company and its Quality System. To drive
continuous improvement, the Executive Management committee will define goals against these objectives. The
following objectives have been established for the 2002 calendar year. The review frequency is noted where
periodic review is defined.
Business/Financial performance objectives
 Revenue Performance (daily, monthly)
 Fixed Cost Performance (monthly)
Manufacturing performance objectives
 First Pass Yield at QC inspection, In-circuit Test, and Functional Test (daily)
 On-time delivery percentage of products to our customers (monthly)
 Labor efficiency compared to quote standard (weekly)
 Revenue per employee (daily)
 RMA Value - Percentage of returned product value to total revenue (monthly)
Materials
 Cycle count accuracy
 Inventory turns
 On time delivery from Stockroom to Production floor (weekly)
Program Management
 Gross margin analysis (monthly)
 Customer Survey Results (yearly)
Engineering
 MRB processing time
Human Resources
 Accident lost time
Finance

Budget performance
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3.0
ORGANIZATIONAL CHART
COMPANY X
Executive Committee
CEO / Owner
Finance
Human
Resources
Information
Services
Sales / Program
Management
Operations
Manager
Materials
Engineering
Production
Doc Control
Customer Service
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4.0
QUALITY MANAGEMENT SYSTEM
4.1
Quality System
Company X has defined and manages the processes necessary to ensure that products conform to customer
requirements. The sequence and interaction of the processes is described in the figure below. As a means of
implementing and demonstrating the defined processes, Company X has established, documented, and
maintains a quality management system that is continually improved. Company X has prepared quality system
procedures that describe the processes and systems required to implement the quality management system. The
quality manual, along with several tiers of supporting procedures and documents, define the quality management
system. A matrix list of all quality system procedures is maintained and includes the procedure name and
number, and the current revision. Refer to the Process Map on the next page for a graphical representation of the
Company X Quality Management System.
4.2
Documentation
Company X has implemented and maintains a procedure for controlling all documents and records related to
process and service requirements, as well as to the quality system. This includes Company X documentation,
external documentation, and customer supplied documentation.
The quality manual is maintained and updated by the Operations organization and is available to all personnel as
well as customers. The manual is reviewed at least annually to ensure its compliance with the ISO 9001 standard
and Company Xs continual improvement initiatives.
The creation, approval, maintenance and storage of all documents related to processes and the quality system for
the purpose of delivering conforming product is carried out in accordance with documented procedures. This
system also controls all documents of external origin and supplied by customers, and ensures that current
applicable documents are readily available to personnel performing their jobs.
Quality records are maintained to show that the required quality levels are achieved and to verify the
effectiveness of the quality system. Quality records are stored and maintained in such a way that they are
protected and readily available.
Refer to procedure 212-002 Document and Record Control.
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Company X Enterprise Process Map
ISO
7
Product Realization
Main Production Turnkey Stream
Sales / Marketing
ISO
7.2.2
Program Management
Co X
N/A
ISO
7.2.2
Sales
Process
Co X
N/A
Materials / Production Control
Forecast
Production Manufacturing / Test
Request
For Quote
ISO
7.2.2
P.O.
Request
For
Service
Co X
261-002
ISO
7.2.2
RMA
Co X
261-008
Change
/ New
No
Plan
Schedule
Yes
Procure
Material
ECN
ISO
7.4
Customer
Requirements
Co X
221-002
Recieve /
Inspect
Material
ISO
7.4.3
Stock /
Pick
Material
Co X
242-001
ISO
7.5.5
Program
Management
Build /
Inspect
Order
Work
Order
Release
Co X
222-004
ISO
8.2.4
Customer
Review
Co X
242-004
ISO
8.2.1
ECN
ISO
7.5.1
Co X
212-001
ISO
7.5.5
Co X
222-003
Ship
Order
Co X
N/A
Customer
Satisfaction
Engineering / Doc Control
MRB
ISO
8.3
ISO
1
Co X
140-001
Scope
ISO
2
Normative Reference
ISO
3
Terms and Definitions
ISO
4
Co X
241-005
Co X
140-001
Quality Management
System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual (Co X 140-001)
4.2.3 Control of Documents (Co X 212-002)
4.2.4 Control of Records (Co X 212-002)
ISO
6
Co X
140-001
Resource Management
6.1 Provision of Resources
6.2.1 Human Resources
6.2.2 Competence, Awareness,
and Training (Co X 250-005)
6.3 Infrastructure
6.4 Work Environment
ISO
5
Co X
140-001
Management
Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communications
5.6 Management Review
5.6.2 Review Input
5.6.3 Review Output
ISO
8
Co X
140-001
Measurement, Analysis,
and Improvement
8.1 General
8.2.2 Internal Audit (Co X 241-006)
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product (Co X 241-005)
8.4 Analysis of Data
8.5.1 Continual Improvement
8.5.2 Corrective Action (Co X 241-008)
8.5.3 Preventive Action (Co X 241-008)
Process
Support
Group
Major Requirements of
ISO
ISO
#.#.#
ISO Elements
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5.0
MANAGEMENT RESPONSIBILITY
5.1
Management Commitment
Company Xs Executive Committee has the management responsibility at Company X. They are committed to
driving the development and improvement of the quality system, which includes:
 ensuring the availability of resources
 establishment and review of the quality policy and quality objectives
 implementing a plan of improvement to the quality management system.
The Executive Committee also has the responsibility to communicate the importance of meeting customer, safety
and regulatory requirements throughout the organization. This communication occurs in both the monthly allemployee meeting and the daily production status meeting.
5.2
Customer Focus
The business model and systems at Company X are designed with customer needs being the core focus. The
Executive Committee accurately identifies adjustments that must be made to ensure a strong alignment with
customer needs. To achieve this alignment they review new customer requirements, customer surveys, and
market analysis reports and perform a gap analysis to determine if the currently defined Company X process
meets or exceeds the customer needs and that Company X is able to effectively translate these needs into the
required formats for the product realization process. Based on this analysis the Executive Committee will decide
whether the systems and resources should be changed or upgraded to accommodate the new requirements or
whether the customer’s business is not a good fit for the company.
5.3
Quality Policy
The Executive Committee has published the quality policy and instills Company Xs commitment to the policy.
They also ensure that the policy is understood, implemented, and maintained by all personnel. The quality policy
shall be periodically reviewed by the Executive Committee to ensure it is appropriate and suitable for Company X,
that it includes a commitment to meeting all requirements, shows continual improvement, and provides a
framework for establishing and reviewing the quality objectives. See section 2.0 Quality Policy for details.
5.4 Planning
The quality management system and sustaining processes support the quality policy and objectives (refer to
section 2.0). An effective quality management system will assist Company X in meeting the needs of our
customers through the on time delivery of error free products. The Executive Committee maintains the strategic
plan to achieve the quality objectives and other requirements. They review this plan periodically to ensure its
integrity and synchronization with new requirements.
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
The Operations manager is responsible for ensuring that responsibilities and authorities are defined and
communicated within the organization. Job descriptions are maintained by the Human Resources department,
which outlines the responsibilities for all employees. These responsibilities are communicated during the
employee review process and outlined in work procedures.
All levels of personnel have the authority to halt nonconforming processes and recommend corrective or
preventive responses using the proper documented procedures.
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5.5.2 Management Representative
The Operations Manager owns the management of the quality system and objectives. As the Quality
Representative for the organization he is responsible for ensuring that the quality objectives are met and that
continual improvement projects are implemented with the goal of meeting each objective.
5.5.3 Internal Communication
The Executive Committee is responsible for identifying and establishing the key communication processes at
Company X. These processes are designed to review the status of key production and quality objectives and to
identify the corrections or resources needed to achieve the objectives. The two primary communication forums
used are the monthly employee meeting and the daily production meeting.
5.6 Management Review
To monitor the effectiveness of the quality system, Company X reviews its quality objectives at established
intervals, which are adjusted based on the business needs, risk assessment of the objective, and stability of the
metrics. The Executive Committee shall review the quality management system at least annually to ensure its
suitability, adequacy and effectiveness. The review shall assess opportunities for improvement and the need for
changes to the quality management system, and shall include inputs from audit results, customer feedback,
process performance, product conformity, preventive and corrective actions, and any recommendations and
changes that could affect the quality system. Records of reviews are maintained that include decisions and
actions related to improvement of the quality management system, improvement of processes, improvement of
product, and resource needs.
6.0
RESOURCE MANAGEMENT
6.1
Provision of Resources
Company X shall determine and provide, in a timely manner, all resources needed to implement and improve the
processes of the quality management system, and to address customer satisfaction. To achieve an adequate
resource model, the Operations Manager shall audit that the customer/QMS requirements can be achieved within
the economic constraints of the business. Evidence that adequate resources have been provided are
documented in the Resource Plan and Operations Budget maintained by the Operations Manager
6.2
Human Resources
All personnel who are assigned positions defined in the quality management system shall be competent on the
basis of applicable education, training, skills, and experience. Company X shall provide all necessary training to
satisfy the needs of the quality system. Personnel at each relevant function and level shall be made aware of:
 the requirements of the quality system
 the importance of conformance
 the impact of their work on quality
 the benefits of improved performance
 their roles and responsibilities in achieving conformance
 the potential consequences of departure from the specified procedures
Refer to procedure 250-005 Hiring, Training and Verification for additional information.
6.3
Infrastructure
Company X shall determine, provide and maintain the facilities required to achieve the product conformity,
including, but not limited to, workspace and associated facilities, equipment, and supporting services.
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6.4
Work Environment
Company X shall determine and manage the work environment required to achieve product conformity. As a
minimum, the facilities, including workstations and equipment, shall be maintained in a state of order, cleanliness,
and repair that is appropriate to the process.
7.0
PRODUCT REALIZATION
7.1
Planning of Product Realization
Company X begins to develop its plan for product realization during the Request For Quote (procedure 261-002
Quoting Process) process. It is at this time that the requirements of the new product are evaluated and it is
determined whether these requirements can be incorporated into the current business and manufacturing process
models. After the customer accepts the quote, the product requirements are integrated into the Company X
system using the Engineering Change Notification process (per procedure 212-001 ECN Process).
7.2
Customer Related Processes
7.2.1 Determination of Requirements Related to the Product
The Sales and Marketing department owns establishing communication with the customer and using a sales
process to identify the needs of the customer and how Company X can address these needs. If Sales determines
that the customer needs are a potential match for Company Xs capabilities, they will initiate the Request For
Quote process (per procedure 261-002 Quoting Process).
7.2.2 Review of Requirements Related to the Product
During the Request For Quote process, key contacts from Sales, Engineering, Program Management, Materials,
and Document Control review the documentation provided by the customer to ensure that all requirements can be
met by the currently defined production and quality processes. This review is documented in the 261-005
Turnkey Kickoff System procedure.
7.2.3 Customer Communication
Sales and marketing own determining and establishing customer communication with new customers and driving
the initial RFQ process. Once the initial RFQ is secured, Sales transfers the responsibility for customer
communication to the Program Management department. A single program manager is then assigned as the
primary customer contact and brokers all communication between other Company X departments. Program
Management uses the 261-008 Order Confirmation and 261-003 Customer Issue Management procedures
7.3
Design and Development
This section does not apply to Company Xs quality system. Company Xs customers are responsible for the
control and verification of the design of their product, and therefore this portion is excluded.
7.4
Purchasing
Company X maintains documentation to control all purchases that are required for achieving product that
conforms to customer requirements in accordance with procedure 221-002 Placing/Managing Purchase Orders.
Purchases are procured from approved suppliers in accordance with procedure 221-004 Supplier Management.
All purchases are verified and inspected in accordance with procedure 242-001 Incoming Quality Control.
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7.5
Production and Service Provision
7.5.1 Control of production and service provision
To clearly define and control the build process, Company X maintains detailed work instructions called
Manufacturing Process Instructions (MPI) (see procedure 212-003 Manufacturing Process Instructions), which
merges the customer requirements with industry specific manufacturing standards to define the specific process
that is used to accurately build, inspect, and test a given product. The Engineering department is responsible for
creating the MPI documentation, which is controlled using the Engineering Change Notification (ECN) process
(see procedure 212-001 ECN Process).
Once a product has been confirmed to meet the customer requirements and it falls within the shipment date
window agreed upon by the customer contract it can be delivered per procedure 222-003 Shipping.
7.5.2 Validation of processes for production and service provision
Company X validates its processes primarily during the introduction or First Article phase of a new product.
During this pilot period a close interaction is maintained with the customer to make sure that the documented
product requirements are complete and can be achieved by the defined process. An analysis of the First Article
phase is performed and used to generate updated process documentation for the production release of a product.
A Design for Manufacturability report can be generated to feed back critical improvement requirements and
suggestions that can be implemented by the customer to ensure a high quality product. Refer to procedure 211009 Design for Manufacturability.
7.5.3 Identification and traceability
Company X uses various identifiers to track material and products through the realization process. The status of
the products are also identified at applicable stages of realization. Components and assemblies have unique
identification requirements, which are specified by the customer and defined in the product work instructions.
Product that has been inspected and tested and exhibit no failures are stamped according to the product work
instruction, which is controlled using the procedure 241-015 Control of Quality Stamps.
7.5.4 Customer property
Customer documentation is collected and controlled at Company X using procedure 212-002 Document and Data
Control. Customer owned property is controlled in accordance with procedure 211-004 Customer Supplied
Product
7.5.5 Preservation of product
Company X has many processes for defining the preservation of materials and products. The primary
documentation for defining these requirements for a given product is the Manufacturing Process Instructions
(MPI) (see procedure 212-003 Manufacturing Process Instructions). The MPI defines any special identification,
handling, packaging, storage and protection required during assembly and once completed as a finished product.
Company X also maintains separate procedures (ESD, Moisture Sensitive Devices, Material Handling) which
define the special requirements for a specific device.
7.6
Control of Monitoring and Measuring Devices
Company X maintains documented procedures for controlling, calibrating, and maintaining all test and
measurement equipment that affect product quality. The accuracy of test and measurement equipment is
controlled to assure compliance with test, inspection, and process instructions. Refer to procedure 211-001
Calibration Procedure for additional information.
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8.0
MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1
General
Company X uses the product work instructions, referred as Manufacturing Process Instructions (MPI) (see
procedure 212-003 Manufacturing Process Instructions), to validate product conformity. The MPI specifies the
requirements needed to correctly manufacture a product and what validation mechanisms (Inspection, MDA/ICT,
Functional Test) are used to measure these requirements. Each of these validation mechanisms generates
pass/fail and defect information for the product. Defect information is aggregated daily into a Quality database as
a quality record and presented to production, engineering, and management where corrective action is
determined and tracked. The defect information is also summarized in defect pareto charts and yield trends and
key improvement projects are prioritized. Company X also utilizes the Internal Audit Process to measure and
monitor the conformity of the quality management system, as well as continually improving its effectiveness.
8.2
Monitoring and Measurement
8.2.1 Customer satisfaction
Company X uses the following key objectives to determine customer satisfaction. The organization monitors
these objectives and correlates them to customer perception. Refer to section 2.1 for specific objectives.




On-time delivery – Formal quality metric. Measures Company Xs ability to meet the scheduling
requirements of the customer.
RMA value – Formal quality metric. Measures the product that the customer returns to Company X for
rework because of workmanship and/or material defects. Analysis of these test or inspection escapes is
performed and corrective action is implemented to eliminate future returns.
Deloitte & Touche customer survey – 3rd party report generated annually. Company X views the
formalized customer survey as a key, unbiased indicator of customer satisfaction because each of the
customer interviews are performed anonymously without Company X involved to bias the feedback.
Experience has shown that giving the customer advanced notice of these surveys allows them to solicit
feedback from their entire organization which provides more comprehensive feedback.
Customer performance meetings – Face to face communication between key contacts. These meetings,
executed on an informal quarterly schedule, allow solid relationships to be developed and maintained
between the key customer and Company X stakeholders. No objective quality evidence is maintained for
these meetings.
Company X uses all these customer satisfaction objectives to define key elements in both budgeting and
continual improvement plans.
8.2.2 Internal audit
The Company X Internal Audit System is designed to cover the Manufacturing Process Audits and the Quality
System Audits as two different components that reflects how an opportunity for improvement is detected,
addressed and documented with clear evidences of solutions and no recurrences of non-conformances. All
internal audits are performed by a trained internal auditor that reports the findings, as defined in the Internal Audit
Program procedure 241-006.
The first component is the Manufacturing Process Audit System which is consistently implemented by process
cells. A checklist is maintained by the operator that is used to setup the operation. This checklist is audited by a
qualified internal auditor. Any condition out of the predefined factors on the checklist is treated as a nonconformance through a process discrepancy report that may trigger other corrective actions depending on the
severity of the non-conformance.
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The second component, the Quality System Audits, is based on auditing the general Quality System. The audits
are scheduled for the different areas, as defined by the Quality Engineer in charge of internal audit process.
8.2.3 Monitoring and measurement of processes
Company X uses it’s quality objectives, internal audits, and management review processes to measure the
effectiveness of the Quality Management System. When planned results are not achieved, remedial and
corrective action is taken per procedure 241-008 Preventive and Corrective Action.
8.2.4 Monitoring and measurement of product
Company X monitors and measures key characteristics of the product during the manufacturing process to verify
all customer requirements and manufacturing standards have been met. Written work instructions are used
throughout the manufacturing process to define specified monitoring and measurement criteria required for each
product.
In-Process Inspections
In process inspections are performed by production in accordance with the work instruction.
Additionally, Acceptable Quality Level (AQL) inspections are performed by the Quality Control department when
significant defects are detected in a given work cell. Refer to procedure 241-016 AQL Sampling and the specific
work cell procedures for more information on the AQL inspection process.
In-Process Testing
Manufactured product is tested per customer specified requirements and may include, but is not limited to, incircuit testing, hi-pot testing and functional product testing. All testing is performed in compliance with written test
procedures. Non-conforming product is identified and segregated for rework or disposition by the Material Review
Board (MRB).
Records of test status are maintained and provide an indication of acceptance or a description of the defects
found and corrective action taken. Reference work area procedures for additional information.
Final Inspection and Test
Final inspection includes a verification of completeness for all activities specified in the work instructions. The final
inspection confirms critical characteristics of the lot through audit and inspection using the applicable customer
specified requirements, industry specifications and/or Company X workmanship criteria. Only when conformance
to all requirements have been confirmed is the product released for shipment. Final test, if required by the
customer, is performed in accordance with the applicable test procedure. Reference procedure 242-004 “Final QC
Inspection” for additional information. The results of the final inspection and test are logged in the ATS Quality
Database for review and analysis.
Non-conforming products will be reworked to meet specified requirements or sent to the Material Review Board
for disposition.
Customers may waive final inspection, however, this waiver must be documented in writing and approved using a
TMI form as per procedure 212-004 Temporary Manufacturing Instruction.
8.3
Control of Non-Conforming Product
All non-conforming product is controlled to prevent its use in the process or shipment to the customer. The
responsibilities and authorities for dealing with nonconforming product are defined in procedure 241-005 Materials
Review Board. This procedure also outlines the controls and overall requirements, such as, identification,
segregation, disposition, corrective action, and quality records.
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8.4
Analysis of Data
Nonconformance data is analyzed at many intervals to determine the necessity of corrective action or continual
improvement projects. The Quality Engineering department reviews the non-conformances generated during the
inspection and test processes daily. Non-conformances that fall below the yield lower control limit are
documented and solutions are identified and tracked to validate the continual improvement of the
process/product.
Company X performs analysis of the quality objectives and key predictors (Ex: CAR and audit performance) of a
well functioning quality system to identify continual improvement projects that can be implemented to ensure that
established goals are met.
8.5
Improvement
8.5.1 Continual Improvement
Company X is constantly striving to improve the effectiveness of the quality management system. This trait is
demonstrated by the company consistently meeting its quality objectives by adhering to the quality policy and
leveraging strong quality processes like internal audits, analysis of data, corrective/preventive action, and
management reviews.
8.5.2 Corrective / Preventive Action
The corrective and preventive action program provides a systematic approach to problem (or potential problem)
identification, analysis, corrective action and reporting. This approach is predicated on documented procedures
and open communication for early detection of potential or actual quality problems and for correcting these issues
promptly. Thorough root cause analysis of a process or product issue followed by a verification of the corrective
actions ensures that the discrepancy was resolved. When applicable, permanent changes resulting from
corrective actions are documented in work instructions and/or process procedures. Significant issues and the
actions taken to resolve the issue are reviewed as part of management reviews. Reference procedure 241-008
“Preventive/Corrective Action System” for additional information.
8.5.3 Preventive Action
See section 8.5.2
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