2. Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
ISO 9000 AND QUALITY MANUAL OUTLINE
This out line of The ISO 9000 requirements for quality control is presented to those who are engaged
in the production of machined items. The Forms referred to in the text may be acquired by emailing
me at Abraham.bolden@gmail.com. Interactive SPC Charts are also available. ISO 9000 interactive
form templates are also available for a nominal fee.
Quality Program Documentation
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
3. Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
NAME OF COMPANY, Incorporated Quality Program is governed by comprehensive documentation as
referenced herein. Procedures, work instructions, forms, drawings, and similar documentation used by
organizations whose direct or supportive participation in processes affecting product Quality, are formally
documented and controlled. All such documents are contained in readily identifiable, easily accessible
controlled manuals or libraries placed at convenient locations throughout the company.
Manual Issuance
Date Issued:
Issued To:
Department:
Telephone:
Controlled Copy: Uncontrolled Copy:
Control No.
If you need additional copies or additional information, please contact the Quality Control Manager.
By Abraham W. Bolden, Sr.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
4. ISO 9000 QUALITY MANUAL REVISION HISTORY
REVISION APPROVAL
CHANGE
DATE
PAGE
NO.
CHANGE
DESCRIPTION
COMMENTS NAME
SIGNATURE
APPROVAL
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
5. This manual is hereby APPROVED as a complete documentation of those procedures and practices to be
used by the NAME OF COMPANY, INCORPORATED for the quality assurance of all manufactured
goods and contracted services. This manual should be considered as confidential and the contents of same
may not be revised, altered, copied or disseminated without the written permission of the President of
NAME OF COMPANY, INCORPORATED or the Quality Control Manager.
Signed By the Below Administrators
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 5
6. Table of Contents
Program Description
1.0 Introduction
1.1 Scope
1.2 Purpose
1.3 Authority
1.4 Issue of the Manual
1.5 Amendments
1.6 Review
1.7 ISO Program Representative
1.8 Cost of Quality
1.9 Definitions
2.0 Company Quality Policy
3.0 Organization Charts
4.0 Quality Policies and Responsibilities
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
4.7 Control of Customer - Supplied Product
4.8 Product Identification and Tractability
4.9 Process Control
4.10 Inspection and Testing
4.11 Control of Inspection, Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Non Conforming Product
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packing, Preservation and Delivery
4.16 Control of Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 6
7. 1.0 Introduction
This manual outlines the policy of the company relating to its Quality Management
System (QMS).
The Quality Program Manual (QPM), issued and controlled by NAME OF COMPANY,
Inc. defines the Quality Management System, which is effective across all disciplines and
at all, levels within the company.
1.1 Scope
This Quality Program Manual applies to all activities and personnel within NAME OF
COMPANY, Inc.
1.2 Purpose
The primary purpose of this Quality Program Manual is to describe and document the
Quality Program currently in practice at NAME OF COMPANY, Inc.
This Manual is the central source of general policies, procedures, and responsibilities that
in turn authorize and govern creation of subsidiary quality related documentation and
activities.
This Manual provides comprehensive evidence to all customers, supplies, and employees
that NAME OF COMPANY, Inc. is committed to establishing and maintaining
acceptable levels of measurable Quality in its products and services.
The requirements and procedures addressed in the Quality Manual are intended to meet
the requirements of ANSI/ASQC Standard Q9000 - 1994 (ISO 9002) and customer QA
specifications.
1.3 Authority
This manual is issued under the authority of the President of NAME OF COMPANY,
Inc.
1.4 Issue of the Manual
Controlled copies of the Manual will be numbered and registered. The Master copies of
the manual will be held by the Quality Control Manager and Management
Representative. The NAME OF COMPANY, Inc Management Representative is
responsible for the issuance of amendments to the Manual, withdrawal of obsolete
information and the maintenance of the master copies of the manual.
Uncontrolled copies may be distributed to organizations or persons at the discretion of
the Management Representative. These will be current at the date of issue only and will
not be subject to amendment action. These copies will be annotated "Uncontrolled
Copy."
1.5 Amendments
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 7
8. Controlled Manuals will be updated and revised as required. The issue of amendments
requires approval by the Management Representative.
1.6 Review
The Manual will be reviewed at a minimum annually and the Quality System audited
over this 12-month period to affirm that the current practices conform to the policies set
out in the manual.
The Quality Manual is to be treated as confidential and must not be copied, re-printed or
the contents divulged to a third party without the permission of the Quality Manager.
1.7 ISO 9000 Management Representative
The NAME OF COMPANY ISO 9000 Management Representative is responsible for all
matters concerning the Quality Manual and shall interface directly with the ISO 9000
Program Registrar on all matters in connection with the ISO 9000 program.
Representative: Quality Control Coordinator
1.8 Cost of Quality
The President, vice-President and Administrative Assistant periodically address the Cost
of Quality. Actual cost data is considered company confidential. This quality program is
designed to produce continuous improvements in all operations. Improvements in quality
are measured and evaluated using the cost of quality information.
1.9 Definitions
Acceptance Criteria
Defined limits placed on characteristics, materials, products or services.
Audit
A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Calibration
Comparison and adjustment to a standard of known accuracy.
Conformance
Compliance with specified requirements.
Concession
Written authority to use or release a quantity of material, components or stores already
produced, but which do not conform to the specified requirements.
Control
To exercise authority over and regulate.
Control Feature
A documented activity to ensure conformance with specific requirements of applicable
specifications.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 8
9. Corrective Action
Measures taken to rectify conditions adverse to quality and to minimize recurrence.
Defect
Not according to contractual specifications or fit for intended usage.
Documentation
Recorded information.
Equipment
Any simple completed unit that can be used for manufacture, processing or assembly.
Failure
Any condition which prevents the product or service from performing its specified
function.
Finding
Objective evidence that a control feature of the approved quality program was not
implemented.
Grade
An indicator of category or rank related to features or characteristics that cover different
sets of needs for products or services intended for the same functional use.
Inspection
Activities such as measuring, examining, testing, gauging one or more characteristics of a
product or service and comparing these with specified requirements to determine
conformity.
Job Work Instructions
A document that provides detail "how to" instructions to accomplish a task.
Quality System Review
A formal evaluation by top management of the status and adequacy of the quality system
in relation to quality policy and new objectives resulting from changing circumstances.
Non-conformity
The non-fulfillment of specified requirements.
Objective Evidence
Facts that are observed and documented.
Observation
Evidence that a survey able / auditable element exists which is not contrary to
documented requirements, but may warrant further qualification or improvement.
Part
Individual pieces used in the assembly of single equipment units.
Quality
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 9
10. Conformance to specified requirements.
Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a
product or service will satisfy given requirements for quality.
Quality Control
The operational techniques and activities that are used to fulfill requirements for quality.
Quality System
The organizational structure, responsibilities, procedures, processes and resources for
implementing Total Quality Management.
Servicing Supplier activities at the interface with a customer and the results of all supplier activities
to meet the customer needs.
Quality Procedure (QP)
A document that specifies or describes how an activity is to be performed. It may include
methods to be used, equipment to be used and sequence of operations.
Subcontractor
Any individual or organization that furnishes materials, products or services.
Specification
The document that prescribes the requirements with which the product or service has to
conform.
Tractability
The ability to trace the history, application or location of an item or activity, or similar
items or activities, by means of recorded identification.
Vendor
Any individual or organization that furnishes materials, products or services.
Verify
To determine conformance to specified requirements.
Wkpro
Work Procedure and instruction detailing actions to be performed at specific work
station.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 10
11. 2.0 Company Quality Policy
All products and services provided by NAME OF COMPANY, Inc. shall conform to the
requirements specified. All employees have the responsibility to carry out their work
assignments in accordance with this Quality Policy and other quality system
documentation.
We are committed to continually improving all products and services and to establish
NAME OF COMPANY, Inc. as a Quality leader in our field.
In order to meet our goals we will pursue the following objectives:
Provide our customers with only the highest quality products and services.
Provide those products on time.
Provide our customers with the best pricing and value for our products.
Provide totally open communications with our customers in order to meet the customer's
needs.
Provide a system for Continuous Quality Improvement in conformance with procedures
required by the International Standards Organization.
Provide for employee involvement, motivation and training.
Utilize Statistical Process Control where the absence of statistical data would be
detrimental to the quality of the product.
The quality program described in this Quality Program Manual has been specifically
designed to meet the requirements of International Standard ISO 9002 and to provide the
framework to allow accomplishment of the quality objectives and goals of the NAME OF
COMPANY, Inc.
The Management Representative has the responsibility for definition, implementation and
maintenance of this quality program. The Management Representative shall ensure that
this Quality Policy is understood, implemented, and maintained at all levels of the
organization.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 11
12. 3.0 Organizational Charts
3.1 Organizational Reporting
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 12
PRESIDENT
OFFICE
PERSONNEL
QUALITY CONTROL
MANAGER
PRODUCTION
MANAGERQUALITY CONTROL
COORDINATOR
LAYOUT AND
FINAL
INSPECTORS
FOREMAN
SECOND
OPERATIONS
FOREMA
N
SHIPPING
SCREW MACHINE
OPERATIONS AND
PERSONNEL
2ND
OPERATIONS
PERSONNEL
SHIPPING
PERSONNEL
FOREMAN
SHIPPING AND
RECEIVING
PRODUCTION
CONTROL
13. 4.0 Quality Policies and Responsibilities
4.1 Management Responsibility
4.1.1 Scope
This policy defines the corporate commitment to quality.
4.1.2 Reference
ISO 9002: 1994, Requirement 4.1.
4.1.3 Policy
The corporate quality policy of the NAME OF COMPANY, Inc. is stated in the
Company's Quality Policy that has been developed and agreed to by the Senior
Management of the Company. The company’s Quality Policy is stated in Section 2.0 of
this manual.
The Company is committed to achieve this policy through the implementation and
maintenance of an ISO 9000 Quality Management System.
This commitment seeks continual improvement of the system to achieve the company
mission. Senior management will review the Quality Management System on an annual
basis to ensure its continued effectiveness.
The company is committed to ensuring that all staff is responsible for the quality of their
work, and so the personnel who perform the operations carry out verification.
4.1.4 Responsibilities
It is the responsibility of the President of NAME OF COMPANY, Inc. to provide the
resources necessary to implement and maintain the Quality Management System.
The Screw Machine Company, Inc. ISO 9000 Management Representative is responsible
for all matters concerning the Quality Manual and shall interface directly with the ISO
9000 Registrar on all matters in connection with the ISO 9000 Program. The
Management Representative shall ensure that the quality system is established,
implemented and maintained in accordance with ISO 9002:94.
The Management Representative is responsible for the coordination of the management
review activity.
The Management Representative is responsible for issuing a copy of the Company
Quality Policy to new employees, and all Managers are responsible for ensuring that their
subordinates are conversant with the company's Quality Policy and its Quality
Management System.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 13
14. 4.1.5 Teamwork
Teamwork is the strategy for the company to promote continuous improvement by way
of employee involvement. Employee involvement is established and tracked in
accordance with the Management Review process.
4.1.6 Management Review
The President and Functional Department Heads shall review the Quality System
annually in conjunction with the Management Representative to ensure its continued
effectiveness.
The review shall address as a minimum the following:
• Confirmation that the Statement of Policy and Authority is still valid
and requires no change
• A review of the Quality Program Manual and Standard Procedures to
confirm that they meet the requirements of ISO 9002
• The identification of weaknesses and deficiencies in the Quality
System, including those identified as a result of internal and external
quality audits and consideration of possible improvements
• Wastage, loss and client complaints incurred throughout the year to
identify possible savings and reconsideration of existing working
practices
• Verification that corrective action procedures are effective
The management review shall be conducted in accordance with the Standard Procedure
referenced in 4.1.7.
The result of this review shall be documented and agreed non-compliances shall be
processed in accordance with the Company's corrective action system (refer to Section
4.14 of this Manual).
4.1.7 Internal Quality Audit
The Management Representative shall be responsible for the planning and
implementation of scheduled and unscheduled quality audits to verify compliance with
the requirements of the Quality Management System.
Quality audits shall be conducted by suitably qualified personnel, as nominated by the
Management Representative in conjunction with the Quality Manager, in accordance
with the Standard.
Each element of the Quality Management System shall be audited at least once per
annum; however, the frequency of audit of each criterion may be altered on the basis of
previous results, at the discretion of the Quality Manager.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 14
15. The Management Representative shall report to the President and Functional Department
Heads the results of the audit and recommend corrective action as appropriate, to ensure
adequate implementation.
Agreed corrective action shall be implemented in accordance with the requirements of
Section 4.14 of this Manual.
4.1.7 Documents Implementing This Policy
QP 117 Internal Quality Audits
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 15
16. 4.2 Quality System
4.2.1 Scope
This policy defines the quality system operated by NAME OF COMPANY, Inc. to
ensure that all products and services conform to customer requirements.
4.2.2 Reference
ISO 9002: 1994, Requirement 4.2
4.2.3 Policy
The Company will operate a Quality Management System based on policies and
procedures that are documented to meet ISO 9000 standards.
The Quality Management System is structured in three levels. Level One is documented
in the form of a Quality Program Manual and contains the corporate policies and
responsibilities. Level Two contains the operating standard procedures of the Company
that are referenced to the Quality Management System requirements of the Quality
Program Manual.
Level Three is the function specific support documentation and forms.
4.2.4 Responsibilities
The Quality Manager in conjunction with the Management Representative bears the
prime responsibility for establishing and maintaining an effective and economic Quality
Management System.
They will resolve any conflicts or difficulties involved in the implementation of the
Quality Management System and will ensure that corrective action necessary to prevent
recurrences of system shortcomings or non-conformance is implemented.
All Functional Department Heads and employees are responsible for the maintenance of
the Company Operating Procedures in their area required for the implementation of the
Quality Management System.
It is the responsibility of all members of Management to familiarize themselves with the
Quality Management System requirements and to ensure that these are observed
accordingly.
4.2.5 Documents Implementing This Policy
QP 107
Quality Policy, dated
Organization Chart
Wkpro-5 -Work Instructions, Quality Control
4.3 Contract Review
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 16
17. 4.3.1 Scope
This policy defines the way in which customer requirements will be established and
reviewed.
4.3.2 Reference
ISO 9002: 1994, Requirement 4.3
4.3.3 Policy
The President of NAME OF COMPANY is responsible for ensuring that all quotations
and contracts are reviewed prior to acknowledgement to the customer. The President
ensures that contracts are adequately defined and documented. This function shall verify
that the company has the capability to fulfill the order. It is the policy of the company
that all quotations that are special orders or nonstandard product be reviewed according
to the Contract Review Procedure prior to release.
The President has the responsibility for organizing contract reviews for customer orders
for products and services, and assigning responsibilities for their execution as required.
Customer orders will be reviewed to ensure that the requirements are adequately defined
and documented to identify any differences between the order and the original quotation
and to determine the company’s capability to meet the specified requirements.
Verbal orders will be documented by the President to ensure that the order requirements
are agreed upon before their acceptance.
The company will not accept any order for which it cannot meet the requirements as
stated in the contract or purchase order.
4.3.4 Contract Amendments
The Production Control Function is responsible for coordinating amendments to any
customer orders. This function shall communicate all changes between the company and
customer and notify all affected departments of relevant changes. Contract amendments
are coordinated, reviewed, approved, and communicated according to the Contact
Review Procedure.
Contract review activities are recorded and related correspondence are documented by
the company and maintained in the customer order file by the Administrative Assistant.
4.3.5 Responsibilities
The President is responsible for ensuring that all quotations or contracts are reviewed
prior to acknowledgement, organizing contract reviews, and documenting all review
activity to ensure that customer requirements are adequately defined and can be met.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 17
18. The Production Control Administrator is responsible for coordinating amendments to any
customer orders.
4.3.5 Documents Implementing This Policy
QP 100 Contract Review
Wkpro-1- Work Instructions, Production Control
4.4 Design Control
4.4.1 The NAME OF COMPANY is not engaged in the design activities or
development and therefore has no procedure regarding this element.
4.4.2 Documents pertaining to this Policy
QP 101 Design Review
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 18
19. 4.5 Document and Data Control
4.5.1 Scope
This policy defines the way in which all documents and data pertaining to the Quality
System are controlled.
4.5.2 Reference
ISO 9002: 1994, Requirement 4.5
4.5.3 Policy
The NAME OF COMPANY, Inc. identifies and controls documents and data that relate to
the requirements of this Standard, as well as documents and data supplied by the customer or
other sources and used to provide products that meet defined requirements.
....
4.5.4 Responsibilities
The Production Control Manager has the authority to review and approve documents
pertaining to the manufacture of product and verifies that current versions of documents
referenced by customer drawings or specifications, or contract -related work instructions, are
readily available to personnel using the source documents.
The Production Control Manager assures that invalid or obsolete documents are promptly
removed from all points of issue or use.
The Management Representative is responsible for ensuring that all Quality System
Documents Quality Manual, Quality System Procedures, and the Quality System-related
Work Instructions are available as required by this Standard and is responsible for the
maintenance of the master list of quality oriented documents and data.
The Production Control Manager in conjunction with the Management Representative is
responsible for the issuance of revised documents pertaining to customer requirements and
specifications. The nature of the revision or change is identified in the document at the time
of issue.
4.5.5 Documents Implementing this Policy
QP 116 Control of Quality Records
QP 102 Document and Data Control
Wkpro-1- Work Instructions, Production Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 19
20. 4.6 Purchasing
4.6.1 Scope
This policy defines the controls on the purchase of materials and services used in the
manufacture of the Company's products.
4.6.2 Reference
ISO 9002: 1994, Requirement 4.6
4.6.3 Policy
The Production Control Manager is responsible for ensuring that all purchased materials
and services required for the manufacture of products will be the subject of written
purchase orders that will clearly describe the type, class, or other precise identification of
the item or service being ordered. The positive identification and applicable
specifications, drawings, process requirements, inspection instructions or relevant
technical data bearing upon the approval of the purchased item shall be included in or
attached to the purchase order upon issuance.
The Production Control Manager is responsible for ensuring that purchasing documents
contain data clearly describing the product ordered.
In line with the Company's policy of using only materials that meet the required quality,
all materials used in manufacture will be purchased to the Company's written
specification.
Wherever possible the Company will procure materials or services from an assessed
source acceptable to the company.
Such assessment will be carried out in accordance with the Company's procedure for the
selection of suppliers. Preference will be given to ISO 9000 assessed and registered
suppliers.
The company will work closely with its suppliers to establish quality procedures that
eliminate the need for incoming inspection. Copies of suppliers quality test and/or
certifications of results will be used for this purpose. Pending being satisfied that a
supplier's quality system is adequate to permit identification testing/ inspection only,
instead of full incoming inspection quality test, incoming materials will be subject to
inspection on a sample basis.
The results of assessment and the subsequent level of supplier performance will be used
to determine the extent of receiving inspection necessary before acceptance of the
supplies by the company.
The Company's right to verify materials at source is specified in its conditions of
purchase. Source verification requirements will be identified at the contract review stage.
4.6.4 Responsibilities
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 20
21. It is the responsibility of the Purchasing Manager to ensure that the procedures
established for the control of the purchasing activity are implemented and maintained.
The Quality Function is responsible for establishing and maintaining the approved
supplier list.
The Manufacturing Function is responsible for ensuring that material specifications will
allow product specifications to be met.
The Quality Function will determine the extent of the receiving inspection activity
required and will coordinate the assessment of vendors quality systems.
It is the responsibility of the Quality Function to coordinate any source verification
activity required.
4.6.5 Documents Implementing this Policy
QP 100 Contract Review
QP 104 Supplier Survey
QP 103 Purchasing
Wkpro-1- Work Instructions, Production Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 21
22. 4.7 Control of Customer-Supplied Product
4.7.1 Scope
This policy defines the way in which Purchaser Supplied Product (or GFP) will be
controlled.
4.7.2 Reference
ISO 9002: 1994, Requirement 4.7
4.7.3 Policy
All Purchaser Supplied Product is examined upon receipt for condition, quantity and
conformance with delivery details.
All items are positively identified and stored in a designated area.
Periodic inspection is performed to detect any damage or deterioration of materials.
Material will only be issued against those orders for which it was supplied.
Any customer product that is either lost, damaged, or is otherwise unsuitable for use is
recorded, and reported to the customer. Such reports and any investigation predicated
upon such reports are documented.
4.7.4 Responsibilities
The Production Control Function is responsible for identifying purchaser-supplied
product during the contract review activity and for communicating such information to
the appropriate company personnel.
The Quality Function is responsible for establishing, implementing and maintaining the
procedures required to meet the requirements of this policy.
4.7.5 Documents Implementing this Policy
QP 105 Control of Customer Furnished Material
Wkpro-4- Work Instructions, Shipping, Packaging, Receiving
Wkpro-5- Work Instructions, Quality Control
4.8 Product Identification and Tractability
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 22
23. 4.8.1 Scope
This policy defines how product identification and trace ability will be established and
controlled.
4.8.2 Reference
ISO 9002: 1994, Requirement 4.8
4.8.3 Policy
The NAME OF COMPANY establishes and maintains a documented procedure for
identifying raw materials and supplies, parts and finished products by means of
applicable drawings, specifications and other documents from receipt and throughout all
stages of production and delivery.
4.8.4 Identification of Incoming Materials
The Material Handler is responsible for ensuring that all materials are clearly identified
either individually or as a lot while they are located at Shipping and Receiving or in
transit to storage or use in production. The Material Handler maintains records
identifying incoming materials by Part Number, and their corresponding purchasing
documentation such as specification and other pertinent data.
The Production Control Manager records the receipt of materials and maintains accurate
and timely records on inventory location and age, and updates inventory status on a semi-
annual basis.
4.8.5 Identification of In-Process Materials
The Production Manager and shop supervisory personnel are responsible for assuring that
in-process materials are clearly identified.
Manufactured items are traced by means of job cards and shop routing instructions which
identifies the material (part number and description) shows its routing, and denotes its
current state of processing. Stock items are identified by part number and customer.
4.8.6 Traceability
The NAME OF COMPANY maintains records for each finished product which include
the applicable routing sheets, engineering drawings, and contract specifications used for
manufacture. Records pertaining to traceability are maintained for a period of no less
than 3 years. Product traceability is controlled through this procedure.
4.8.7 Documents Implementing this Policy
QP 106 Product Identification & Trace ability
Wkpro-4- Work Instructions, Shipping, Packing, Receiving 4.9 Process Control
4.9.1 Scope
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 23
24. This policy defines the way in which the manufacturing processes are controlled.
4.9.2 Reference
ISO 9002: 1994, Requirement 4.9
4.9.3 Policy
Managers of departments involved in production processes which directly effect quality
of the end product are responsible for ensuring that these processes are identified,
planned and executed under controlled conditions. Controlled conditions are defined to
include the following requirements:
• Documented procedures and / or work instructions for production items
where their absence would adversely affect quality.
• Suitable equipment and working environment, to include compliance
with government safety, environment, and hazardous material-related
regulations.
• Compliance with reference standards, codes, and quality plans and / or
documented procedures.
• Monitoring and control of suitable process and product characteristics,
with an emphasis on those characteristics designated as “special” by the
customer or NAME OF COMPANY, during production. Special
characteristics are designated, documented and controlled as required
by the customer.
• Approval of processes and equipment, as appropriate.
• Criteria for workmanship, which are either written or expressed by
means of representative samples.
• Suitable maintenance of equipment to ensure continuing capability of
the machine or process.
4.9.4 Process Control and Operator Instructions
The Manager of each department with process monitoring and operator instructions is
responsible for ensuring that these work instructions are understandable, sufficiently
detailed, and accessible at the work station and that they are periodically reviewed as the
need arises.
Process Monitoring and operator instructions shall include or reference, as appropriate
• Operation Name and/or Number keyed to process flow requirements
• Part Name and Number
• Current engineering level / date.
• Required tools, gages and other equipment.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 24
25. • Material identification and disposition instructions.
• Customer and supplier designated special characteristics.
• SPC requirements.
• Relevant engineering and manufacturing standards.
• Inspection and test instructions where applicable.
4.9.5 Responsibilities
The Production Management Function is responsible for establishing Workmanship
Standards in the Process Instructions.
It is the responsibility of the Quality Function to ensure that the Quality Control
Instructions adequately specify requirements.
The Quality Manager is responsible for ensuring that the Process and Quality Control
Instructions are established and maintained.
The Production Planning Team is responsible for the planning and scheduling of work
orders.
4.9.6 Documents Implementing this Policy
QP 107 Process Control Production
QP 121 Machine Maintenance
Wkpro-2- Work Instructions, Automatic Screw Machine
Wkpro-3- Work Instructions, Secondary Setup & Operate
Wkpro-5- Work Instructions, Quality Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 25
26. 4.10 Inspection and Testing
4.10.1 Scope
This policy defines the conduct of inspection and testing activities to verify conformance
with specified requirements.
4.10.2 Reference
ISO 9002: 1994, Requirement 4.10
4.10.3 Policy
The NAME OF COMPANY establishes and maintains procedures, work instructions, and
quality plans which define the required inspection and testing activities and related
records used to verify that all product requirements are met prior to product distribution,
processing, or use.
Acceptance criteria, unless otherwise specified by customer contract, in all cases is zero
defects. (C=0)
When specified in the contract or as the need arises to ascertain the quality of materials
used in the production process, the NAME OF COMPANY shall use accredited
laboratory facilities.
4.10.4 Receiving Inspection and Testing
The Production Control Function has the responsibility for ensuring that incoming
product is not used or processed until it has been verified as conforming to specified
requirements. When product is needed in an urgent production situation, the product or
materials are positively identified and recorded in order to permit positive recall in case
that the product or material does not meet customer requirements.
The amount and nature of receiving inspection and testing applied to incoming material
from suppliers is based upon the following factors:
• The supplier’s ability to provide statistical/analytical data to demonstrate
product quality.
• Results of second or third party assessment of supplier’s location.
• Documented evidence of product quality obtained through accredited
contractors or test laboratories.
• The supplier’s ability to provide warrants or certifications, including records of
test results.
• Records of supplier performance.
• Customer requirements and/or recommendations.
Verification through inspection and testing is done in accordance with the Receiving
Inspection Procedure, which addresses such issues as:
• Specification of proper work instructions and/or control plans for receiving
inspection.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 26
27. • Reference to the Nonconforming Material Procedure for isolation, identification,
and control of nonconforming materials.
• Methods for the identification and distribution of acceptable materials.
• Documentation and storage of inspection records.
4.10.5 In-Process Inspection and Testing
The Production Manager is responsible for ensuring that in-process product is held and
not used or processed further until it has been inspected, tested, or otherwise verified as
conforming to specified requirements, except when product is released under positive
recall.
Inspection of in-process materials is done in accordance with In-Process Inspection
Procedures, which addresses such issues as:
• Specification of proper work instructions, standards, and/or inspection plans for
inspection.
• Reference to the Non-conforming Material Procedure for control on
nonconforming materials.
• First Piece product inspection.
• Urgent production situations and positive methods for recall.
• Documentation, use, and storage of records.
4.10.6 Final Inspection and Testing
The Quality Control Manager is responsible for ensuring that no product is dispatched
until the following conditions are verified:
• All final inspection and testing are complete according to the appropriate
documented procedure and/or work instruction or quality plan to show evidence
of product conformance to specified requirements.
• All data and documentation covering inspections and tests specified in the
quality procedures and control plan are available and authorized to show
compliance and that the results meet specified requirements.
The requirements of Section I, element 4.10.4 are addressed in detail in the Final
Inspection Procedure, which addresses such issues as:
• Specification of proper work instructions, standards, and/or inspection plans for
final inspection.
• Reference to the Nonconforming Material Procedure for control of rejected
materials.
• Documentation, use, and maintenance of records.
• Layout inspection of products or other documentation specified by customer.
4.10.8 Inspection and Test Records
Inspection and test records are established and maintained to identify the persons
performing inspection activities, and the results of these verification activities. The
responsibility for generating, filing, and maintaining inspection and test records is
defined in the quality procedures referenced below.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 27
28. 4.10.5 Documents Implementing this Policy
QP 108 Receiving Inspection
QP 109 Inspection & Test Status
QP 110 Final Inspection
QP 111 Quality Assurance
Wkpro-5- Work Instructions, Quality Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 28
29. 4.11 Control of Inspection, Measuring and Test Equipment
4.11.1 Scope
This policy defines the control of inspection, measuring and test equipment used by the
company.
4.11.2 Reference
ISO 9002: 1994, Requirement 4.11
4.11.3 Policy
The Manager of Quality Control is responsible for establishing and maintaining
documented procedures and work instructions for insuring that all inspection, measuring,
and test equipment used in any stage of production is controlled, calibrated, and properly
maintained to demonstrate the conformance of product to the specified requirements.
All equipment used for test and measurements will be subject to annual calibration or
calibration prior to use for the qualifying of any production, as detailed in the appropriate
calibration procedure. Calibration equipment will be traceable to a national or
international standard. Records of calibration will be maintained and a system of call-in
for calibration operated. When equipment is found to be out of calibration, the effect of
that error on product will be reviewed and appropriate corrective action taken.
The annual due date for the calibration of measuring devices shall include a period from
1 week before to 1 week after the due date as entered in the calibration records.
Measuring equipment belonging to any newly hired employee must be calibrated and
assigned an in- house ID number prior to use. The equipment is then documented and
re-scheduled for subsequent calibration.
The Screw Machine Engineering uses documented work instructions to perform gage
repeatability and reproducibility studies to address measurement uncertainty.
The Manager of Quality Control is also responsible for ensuring that the measurement
uncertainty of the inspection equipment is known and that such equipment is used in a
manner consistent with the required measurement capability.
The NAME OF COMPANY provides data regarding measurement device calibration to
its customers upon request.
4.11.4 Procedure
The NAME OF COMPANY has a formal, documented procedure and work instructions
for regularly certifying the accuracy of every inspection instrument that is used in the
manufacturing process, including instruments owned by employees. Instruments used to
verify dimensions or characteristics, or perform functional testing and thereby accept
parts are calibrated periodically.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 29
30. For each item of equipment, a Calibration Record is maintained which describes the
equipment, assigns an ID number, identifies its location as of the date calibrated, lists the
date calibrated and the next date re-calibration is due, and the acceptance criteria.
The calibration record also documents the history of all calibration activity including the
condition of the instrument at the time of calibration. The calibration record is
maintained by Quality Control for a period of 3 years.
Reference and attribute gages issued by quality control are calibrated and/or checked
prior to each issue and a gage issue and calibration record is updated at the time of issue.
The instrument calibration ID number affixed to each measuring device references a
complete history of that device as recorded in the computer based Gagecal file. A
condensed copy of the calibration record pertaining to the ID number is issued to each
employee at the time of calibration. The employee copy of the calibration record
describes the measuring device, shows date calibrated, the date that the next calibration is
due, the name of the person who owns the device, and comments as to the condition of
the instrument at the time of calibration.
All calibrations and related inspections are performed in environmentally controlled or
suitable conditions.
When necessary, outside sources are used to calibrate certain gages and equipment. For
each item of equipment, the Calibration Record is completed and a copy of the gage
certification is required. All calibration services, whether performed in or outside the
plant, are calibrated to standards that are traceable to the National Institute of Standards
and Technology (N.I.S.T.)
Inspection and measuring equipment that is not in current calibration is not used. Newly
acquired measuring instruments are impounded until calibration has been completed.
Employees that use the measuring equipment are responsible for checking the calibration
sticker (or equivalent tag/marker) to ensure that the calibration status is current.
Should calibration activity disclose the potential for discrepant material that has been
shipped, the customer shall be notified of all pertinent information. This notification may
be followed by a request for deviation or waiver.
Calibration activity that discloses the potential for discrepant material that is within the
facilities of the NAME OF COMPANY results in the initiation of a production audit of
parts produced and qualified by any measurement device found to be out of calibration.
If the production is found to be discrepant, a Non-conforming Material Report is
generated.
All inspection, measuring, and test equipment is handled properly and stored in a manner
that prevents accidental damage to ensure that the accuracy and fitness for use is
maintained.
Test hardware or software used as a suitable means of inspection are subject to the
requirements as listed above for inspection, measuring, and test equipment.
4.11.5 Quality Records
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 30
31. The Manager of Quality Control is responsible for the maintenance of calibration records,
including communication to customers regarding the potential for nonconforming
product due to the out of calibration equipment and for ensuring that the control of
measurement equipment meets or exceeds customer requirements.
4.11.6 Measurement System Analysis
The Manager of Quality Control is responsible for the maintenance of gage repeatability
and reproducibility and other applicable statistical studies designed to analyze
measurement system uncertainty. The NAME OF COMPANY has documented work
instructions which include analytical methods and acceptance criteria that meet the
specified calibration requirements.
4.11.7 Documents Implementing this Policy
QP 112 Control of Measuring & Test Equipment
QCP 100 Calibration Procedures
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 31
32. 4.12 Inspection and Test Status
4.12.1 Scope
This policy defines the way in which inspection and test status will be defined.
4.12.2 Reference
ISO 9002: 1994, Requirement 4.12
4.12.3 Policy
All materials and products will be suitably identified throughout each stage of
manufacture by the use of routing tags, labels, inspection records, physical location
designations, or other suitable means, which indicate the conformance or
nonconformance of the product with regard to the inspections performed. The
identification of inspection and test status is maintained, as defined in the company’s
procedures and work instructions and as required by the customer, throughout production
to ensure that only product that has passed the required inspections is routed to the next
operation or for shipment.
Defective products discovered during the production process will be segregated from all
other material pending investigation and final disposition and all such material will be
clearly identified.
Inspection and test records will enable the identify of the inspection authority responsible
for the release of the finished product to the established.
4.12.4 Responsibilities
It is the responsibility of the Department Manager to ensure that the procedures required
to implement this policy are established and maintained.
It is the responsibility of all personnel to observe the requirements of the procedures that
implement this policy.
The Quality Manager bears the ultimate authority for the release of the Company's
products and is responsible for the delegation of such authority.
4.12.5 Documents Implementing this Policy
QP 109 Inspection & Test Status
Wkpro-5 - Work Instructions, Quality Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 32
33. 4.13 Control of Non Conforming Product
4.13.1 Scope
This policy defines the manner of controlling material that does not conform to specified
requirements.
4.13.2 Reference
ISO 9002: 1994, Requirement 4.13
4.13.3 Policy
The Manager of Quality Control in conjunction with the Management Representative is
responsible for maintaining documented procedures and work instructions for ensuring
that product not conforming to specified requirements is clearly identified, quarantined
and segregated to prevent inadvertent use until the material disposition is determined.
All defective material is, immediately upon detection, identified and held pending
investigation and disposition.
Such arrangements apply to material received from suppliers or from internal or external
non-conformances.
All defective products are reviewed to determine the need for corrective/preventative
action and the subsequent material disposition.
Records of all non-conformance are maintained and are periodically reviewed to establish
trends and thereby determine the need for further preventative action.
Material that does not conform to the customer’s specification will be used only after
obtaining the customer’s written deviation or consent.
4.13.4 Nonconforming Product Review
The Quality Control Manager has the responsibility for the initial review and control of
all suspected nonconforming materials. After initial review, the company President,
Quality Control Manager and the person in charge of the department in which the
defective materials were produced have the authority to carry out the following
emergency actions:
• Rework product to meet the specified requirement.
• Accept product based upon customer grant of material deviation.
• Use product for alternative applications where product meets required
specifications.
• Scrap the product.
The occurrence of a nonconforming material condition is documented by use of the
Rejection and Sorting Report. This report describes the nonconformity, addresses the
disposition, and provides statistical information for possible corrective action and/or
process improvement activities to prevent reoccurrence. The information contained in
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 33
34. these reports is tracked and documented in the computer files for the purpose of to
continuously reduce the level of nonconforming product.
Product that is reworked or repaired is re-inspected according to appropriate inspection
procedures and Quality Plans. Pertinent instructions for rework are either written or
delivered orally to appropriate personnel.
The Material Review Board is composed of the company President, Management
Representative, Quality Control Manager and the Manager of the department responsible
for the nonconforming materials. The MRB shall convene as necessary in order to
disposition nonconforming materials received from the customer or discovered during
production activity.
4.13.5 Control of Reworked Product
Reworking of product is controlled by the manager of the department responsible for
bringing the product within required specification. All reworked product is re-inspected
prior to shipment and the product supplied to the customer may not show visible evidence
of rework activity unless the customer has granted concession or deviation.
4.13.6 Engineering Deviations and Authorizations
The Management Representative is responsible for managing the customer authorizations
of products, including materials provided by suppliers that differ from those currently
approved according to the following guidelines that include:
• Obtaining written customer approval of Deviation Requests, Engineering
Changes and Corrective Action Requests.
• Ensuring that the proper documentation is available for materials shipped under
customer deviation or waiver.
It is the responsibility of all personnel detecting a non-conformance to ensure that it is
properly identified, segregated and reported.
The responsibilities for determining disposition of defective material are defined in the
Procedures that implement this policy.
4.13.7 Documents Implementing this Policy
QP 113 Non Conforming Material
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 34
35. 4.14 Corrective and Preventive Action
4.14.1 Scope
This policy defines how corrective and preventive actions are identified, implemented
and reviewed for effectiveness.
4.14.2 Reference
ISO 9002: 1994, Requirement 4.14
4.14.3 Policy
The NAME OF COMPANY establishes and maintains documented procedures for
implementing both corrective and preventive action. These procedures specify actions
for eliminating the cause of actual or potential quality system problems and related
nonconformities to a degree commensurate with the magnitude of the problem, its
potential outcome, and the level of risk involved. Corrective Action Requests received
from the customer are resolved as required by the customer.
The Management Representative and the Quality Control Manager are responsible for
ensuring that all company personnel involved in the Corrective Action Process and
Preventive Action Program:
• Understand their importance in achieving the goals of the Quality
Policy.
• Are able to provide the personal commitment and resources necessary
to execute corrective and preventive actions in an efficient and timely
manner.
• Are aware of the various problem-solving methods used in determining
corrective and preventive action plans.
• Understand the importance of corrective and preventive action plans in
the Management Review Process.
4.14.4 Implementation of Corrective Action
Corrective Action functions are directed at revising the company’s quality system,
policies, processes, procedures, and work instructions in order to eliminate the root cause
of the quality problem. Corrective Action Procedures are utilized in the following
situations:
• To resolve quality system problems related to nonconformities found
during internal, external, or third party audits, and issues uncovered
during the Management Review process.
• To revise the quality system, work processes, quality procedures, and /
or work instructions to eliminate the cause of a poor quality product,
customer complaint, or internal quality failure. External failures are
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 35
36. handled as required with the customer, and are used as input to the
corrective action process.
• To resolve quality system problems found through the analysis of
customer returns.
Corrective actions are initiated, controlled, and documented through the use of the
Corrective Action Request which is specified in the Corrective and Preventive Action
Procedure.
The responsibility for undertaking the corrective action lies with the Management
Representative in conjunction with the Quality Control Manager. For each corrective
action request, the Management Representative with the assistance of Administrative and
management personnel shall:
• Investigate the extent of the problem.
• Determine the root cause(s) of the problem.
• Decide on corrective action.
• Implement the corrective action.
• Initiate permanent changes in any related procedure/instructions (if
appropriate).
The Management Representative is responsible for ensuring that the Corrective Action
Program is managed effectively. This involves, but is not limited to the following
activities:
• Issue the Corrective Action Request form to the person responsible.
• Follow-up on the progress of Corrective Action activities to help ensure
that the corrective action is completed by the promised date.
• Verify that the corrective action taken is effective.
• Sign off on the Correction Action Report for completed activities, and
close out the correction action.
• Investigate the cause of failure and take appropriate action when the
correction action is not completed according to plan.
• Maintain a system of records for managing the corrective action
documents, monitoring the status of corrective action activities, and
storing closed out Corrective Action Requests for a period of 3 years
minimum.
4.14.5 Implementation of Preventive Action
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 36
37. Preventive action is directed at revising the company’s quality process or tooling to
eliminate the root cause(s) of potential problems. Preventive and Corrective Action
Procedures are used when:
• Potential problems are discovered or opportunities for improvement are
identified during internal, customer, or third party audits.
• Quality records, past production history, customer feedback, process
capability studies, and/or management review reports reveal a need for
the undertaking of preventive action measures.
Preventive actions are initiated, controlled, and documented through the use of the
Corrective Action Request form.
The responsibility for the undertaking of preventive action lies with the Administrative
Staff consisting of the company President, Quality Control Manager, Management
Representative, and Production Manager who are responsible for the related quality
system elements and / or procedures. For each Preventive Action Request, the
aforementioned persons shall:
• Investigate the nature of the weakness.
• Determine the root cause(s) of the weakness.
• Decide on preventive action.
• Initiate permanent changes in any related procedure or instructions (if
appropriate).
The Management Representative is responsible for ensuring that the Preventive Action
Program is managed effectively. This function shall document preventive action
measures, monitor the status of the activity, and store the closed out preventive action
records for a period of 3 years minimum.
4.14.5 Documents Implementing this Policy
QP 114 Corrective and Preventive Action
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 37
38. 4.15 Handling, Storage, Packaging, Preservation and Delivery
4.15.1 Scope
This policy defines the controls employed within the Company for the handling, storage,
packaging and delivery of materials.
4.15.2 Reference
ISO 9002: 1994, Requirement 4.15
4.15.3 Policy
Material handling arrangements are made during all stages of manufacture, inspection
and test in order to prevent any risk to material quality.
The manner in which material is handled and protected is subject to written instructions
where critical handling and transportation considerations are identified. These will refer
to any special containers, and handling devices are provided accordingly.
Materials awaiting use or shipment are identified and segregated in secure storage areas.
Suitable measures are taken to prevent damage or deterioration including a periodic
inspection for materials condition.
The Company's products are packed in accordance with prescribed methods and using
materials designed to ensure that the product quality is maintained during transit. Order
and product identification are clearly marked and will provide for any contract or carrier
requirements.
The product description, destination and transit considerations are specified on the
Company's delivery/dispatch documentation.
4.15.4 Responsibilities
The Purchasing Materials Function is responsible for ensuring that material is properly
received, identified, protected, stored and issued in accordance with the prescribed
routines.
They are also responsible for ensuring that products are properly prepared for dispatch
and are accordingly identified.
The Purchasing and Materials Functions are responsible for the conduct of regular
audits of stock to determine that material is maintained in a satisfactory condition.
The Quality Function is responsible for ensuring that products are properly prepared for
dispatch and are accordingly identified. It is the responsibility of all personnel to adopt
good material handling practices and for observing the written procedures provided.
4.15.5 Documents Implementing this Policy
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 38
39. QP 115 Handling, Storage, Packaging, Preservation, and Delivery
Wkpro-4
4.16 Control of Quality Records
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 39
40. 4.16.1 Scope
This policy defines the maintenance of quality records.
4.16.2 Reference
ISO 9002: 1994, Requirement 4.16
4.16.3 Policy
All essential quality related activities are the subject of records to fully demonstrate the
achievement of specified requirements and the effective operation of the company's
Quality Management System.
Records are suitably stored and maintained to ensure their safekeeping and subsequent
retrieval.
The retention periods and the authority for the disposal of records are defined. Access to
quality related records are made available to the purchaser or his representative as
required.
4.16.4 Responsibilities
The Quality Function is responsible for ensuring that the procedures that implements this
policy is maintained and is effective.
The Quality function will coordinate any access to the quality records required by the
customer.
It is the responsibility of all personnel to ensure that quality related records are compiled
in a complete, legible and accurate manner and are correctly filed and stored in the
location provided where applicable.
4.16.5 Documents Implementing this Policy
QP 116 Control of Quality Records
Wkpro-5- work Instructions, Quality Control
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 40
41. 4.17 Internal Quality Audits
4.17.1 Scope
This policy defines the conduct of internal Quality Management System audits.
4.17.2 Reference
ISO 9002: 1994, Requirement 4.17
4.17.3 Policy
NAME OF COMPANY, INC. will ensure that all aspects of its Quality Management
System are objectively audited.
Audits are scheduled on the basis of thye status and importance of the activity to be
audited.
Results are documented and reviewed by the Management Team to ascertain that the
Quality Management System is effective in achieving its objectives and continues to
reflect the Company's mission.
Trained personnel independent of the department or process under surveillance will
conduct audits.
4.17.4 Responsibilities
The Management Representative will coordinate the audit activities and is responsible for
ensuring that there are sufficient trained auditors to meet the audit program requirements.
The Head of each department being audited is responsible for investigating, planning and
implementing any corrective action agreed upon as a result of the audit.
4.17.5 Documents Implementing this Policy
QP 117 Quality Audits
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 41
42. 4.18 Training
4.18.1 Scope
This policy defines the provisions made within the Company to ensure that all personnel
are adequately trained for the tasks that they are required to undertake.
4.18.2 Reference
ISO 9002: 1994, Requirement 4.18
4.18.3 Policy
All tasks within the Company that are adversely affected by the lack of acquired skill will
be identified and made the subject of a job description that reflects the extent and
evidence of skill required. The Company will use this to appraise the level of
competence of personnel both before and during engagement and to identify training
needs accordingly.
All staff will receive appropriate training before carrying out manufacturing or testing
operations. Training programs are devised to ensure complete familiarity with all
requirements of the process. Records will be maintained of training given, and
completion of training will be subject to an end of training review. Periodic reviews of
training requirements will be made to ensure that training remains effective, and to
identify needs for retraining.
4.18.4 Responsibilities
Functional Department Heads are responsible for ensuring that only personnel who are
suitably qualified perform tasks requiring acquired skill.
It is the responsibility of the Quality Function to analyze instances of non-conformance
for evidence of insufficient skill, job knowledge or training.
The Quality Function is responsible for establishing and maintaining the appropriate
training records.
4.18.5 Documents Implementing this Policy
QP 118 Training
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 42
43. 4.19 Servicing
The NAME OF COMPANY performs no customer service activities
4.19.1 and therefore has no documented procedure regarding this element.
4.19.2 Document pertaining to this policy
QP 120 Servicing of Customer Returns
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 43
44. 4.20 Statistical Techniques
4.20.1 Scope
This policy defines the use of statistical techniques within the Company.
4.20.2 Reference
ISO 9002: 1994, Requirement 4.20
4.20.3 Policy
Where used within the Company, statistical techniques will be selected to be the most
appropriate statistically valid technique for the application.
The techniques used will be defined in procedures, which will prescribe the way the
technique is to be applied and the rules governing its use.
Where statistical techniques are used for product verification due regard will be made to
the contractual requirements of the customer.
4.20.4 Responsibilities
It is the responsibility of all staff specifying the use of statistical techniques to ensure that
the requirements of this policy are complied with.
It is the responsibility of all persons using statistical techniques to observe the relevant
procedures.
4.20.5 Documents Implementing this Policy
QP 120 Statistical Techniques
SPC Manual, dated 5-1-00
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 44
46. TABLE OF CONTENTS
PROCEDURE NUMBER PAGE
Contract Review QP 100 1
Design Review QP 101 5
Document Control QP 102 6
Purchasing QP 103 9
Supplier Surveys QP 104 13
Customer Supplied Materials QP 105 18
Product Identification and Trace ability QP 106 22
Process Control QP 107 26
Receiving Inspection QP 108 29
Inspection Status QP 109 33
Final Inspection QP 110 35
Quality Assurance QP 111 38
Control of Measuring Equipment QP 112 41
Non Conforming Material QP 113 44
Corrective Action QP 114 49
Shipping And Packaging QP 115 53
Quality Records QP 116 57
Quality Audits QP 117 59
Training QP 118 63
Servicing Customer Returns QP 119 66
Statistical Techniques QP 120 67
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016
47. CONTRACT REVIEW QP 100
1. PURPOSE
1.1. This procedure provides specific instructions for the review and acceptance of contractual
agreements, verifying that elements of the proposal effort have been mutually agreed upon
and ensuring implementation of customer contractual requirements.
2. SCOPE
2.1 This procedure applies to product all new or amended orders.
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Administrative Staff
3.2. Production Control
4. GENERAL
4.1. The purchase order and associated documentation are reviewed by the President, Production
Manager, and Production Control to analyze the contractual requirements and note any
differences between the purchase order and the terms outlined in the initial Quotation. Any
significant differences will be discussed with the customer before proceeding.
4.2. The purchase order contractual requirements are compared to existing company production
capabilities and the pre-established proposal summary to determine special requirements. A
contract requirements form is initiated to identify the responsible departments, the scheduled
completion dates and the documents and tasks that must be completed to meet contractual
requirements. Special attention is given to the customer's requirements noted as critical or
safety characteristics.
4.3. Production Control and Administrative Staff representatives review the contract requirements
and all related documents to determine documentation and other tasks to be completed. The
required contractual documents, such as the quality control plan, are forwarded to quality
control for completion.
4.4. Production Control coordinates the contract requirements, summarizing and defining all the
requirements specified on the purchase order or contract, with appropriate quality assurance
personnel.
4.5. The completed and approved contract requirements and such associated documentation as the
quality control plan are forwarded to Production Control for submittal to the customer.
4.6. All contractual agreements and documentation associated with the purchase order and
Contracts are filed in Central Files and maintained for a minimum period of 3 years.
4.7 Verbal orders for items previously manufactured under formal contract are received by the
President or Production Control. Such orders must be confirmed by customer purchase
order within seven (7)days. No verbal order will be processed for parts not previously
manufactured by this company until all aspects of the purchase order and contract
referenced documents for contractual agreements are complete.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 1
48. 4.8 The President in conjunction with Production Control is responsible for the coordinating
amendments to any customer order. Production Control shall communicate, by the
issuance of a temporarily revised drawing, all amendments to the purchase order to all
departments that might be affected by any amendment to the purchase order.
4.9 Contract amendments are reviewed, coordinated, and approved according to the Contract
Review Procedure.
5. PROCEDURE
Responsibility.
5.1. President
Action
5.1.1. Reviews all aspects of the purchase order and contract and referenced documents for
contractual requirements and completes the contract requirements form. Advises the
customer of any significant differences from and exceptions to the pre-established
proposal summary.
5.1.2. Reviews contract schedule commitments for their impact on other contractual
requirements.
5.1.3. Assures that contractual requirements are adequately defined and documented. Where no
written statement of requirement is available for an order received by verbal means, the
president assures that the order requirements are agreed upon before acceptance.
5.1.4. Verifies that NAME OF COMPANY has the capacity to meet the contract
or accepted order requirements.
5.1.4. Approves or rejects the contract or Purchase Order.
Responsibility
5.2. Production Control
Action
5.2.1. Receives proposed amendments to the purchase order, contract or referenced documents
for contractual requirements and notes differences from the pre-established proposal
summary
5.2.2. Forwards proposed amendments to president for approval or rejection.
5.2.3. Communicates all changes to acceptable contracts to relevant departments and
subcontractor, where applicable.
5.2.4. Completes the Quote and forwards a formal serialized quotation to the customer with a
copy of Screw Machine Industry Conditions of Sale requirements.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 2
49. Responsibility
5.3. The Production Control Administrative Staff
Action
5.3.1. Combines information received from quality and technical engineering.
5.3.2. Prepares an estimate cost summary.
5.3.3. Forwards the cost summary to the President for review.
5.3.4. Distributes approved copies of the cost summary to:
• President
• Production Manager
5.3.5. Files all documentation associated with the purchase order and contract in central files.
6. ACCEPTANCE
6.1. Acceptable documents are approved and signed by the President where such approval and
signature is required for completion of the transaction.
7. REJECTION
7.1. Unacceptable documents are returned to the customer for clarification and/or revision
8. RECORDS
Contract review activities are recorded and related correspondence are documented by the company
President and Production Manager and maintained in the customer order file for a period of 3 years
minimum.
9. FORMS
9.1. FO1-01 Quotation Cost Summary Worksheet.
9.2. FO1-02 Parts Processing Worksheet.
9.3 Serialized Quotation.
9.4. Purchase Order.
9.5. Condition of Sale and Manufacturing Practices.
9.6. Job Process Shop Paper.
10. DEFINITIONS
Not applicable
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 3
50. 11. REFERENCE DOCUMENTS
11.1 ISO 9002, paragraph 4.3.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 4
51. DESIGN CONTROL QP 101
1. The NAME OF COMPANY is not engaged in the design activities or
development and therefore has no procedure regarding this element.
DOCUMENT AND DATA CONTROL QP 102
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 5
52. 1. PURPOSE
1.1. This procedure provides specific instructions for the release of drawings and documents,
including subordinate documents and subsequent changes to drawings.
2. SCOPE
2.1. This procedure applies to the control of drawings and documents, including subordinate
documents that explain the engineering requirements, manufacturing processes, assembly
methods, test procedures and inspection instructions related to manufacturing activity.
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Quality Assurance
3.2. Production Control
3.3. Manufacturing
4. GENERAL
4.1. Production Control has the primary responsibility for the preparation, release, initial
distribution and control of drawings, specifications and other design documentation.
4.2. Production Control has the primary responsibility for the preparation, release, initial
distribution and control of subordinate documents that provide fabrication, assembly and
process methods and instructions, such as shop orders, assembly instructions, process
specifications and process procedures or instructions.
4.3. Production Control administers all customer change notifications and subsequent revisions to
the subordinate documents.
4.4. Quality Control has the primary responsibility for the preparation of inspection methods and
instructions and work standards (i.e., accept or reject criteria).
4.5. Quality Control administers all change requests and subsequent revisions to inspection
instructions and work standards.
4.6. The users of the documentation are responsible for the removal of obsolete documentation
from work areas.
4.8. Quality Control audits compliance to this quality procedure.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 6
53. 5. PROCEDURE
Responsibility
5.1. Production Control
Action
Upon the receipt of any customer document, drawing or written specification, the Production
Control Manager shall:
5.1.1. Date Stamp the document or otherwise indicate in the document the day upon which the
document was received.
5.1.2. Review the document for adequacy and completeness.
5.1.3. Approve the document when such approval is necessary.
5.1.4. Assign document, file, or drawing number .
5.1.5. Release the document to Administrative and/or manufacturing personnel
5.1.6. Receive, process, administer and control customer-engineering revisions in a timely
manner.
5.1.7. Determine the number (stock items or work in process) of disposition parts in
manufacturing effected by the revision.
5.1.8. Remove obsolete documents from Master files.
5.1.9. Revise all subordinate documents as applicable.
Responsibility
5.2. Management Representative
Action
5.2.1. Maintains a Master list of quality system documents identifying the current revision
status.
5.2.2 Initiates Engineering change requests.
5.2.3. Reviews and re-issues revised documents in conjunction with Production Control.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 7
54. Responsibility
5.3 Quality Control
Action
5.3.1. Audits and ensures compliance
6. RECORDS
6.1. Customer change orders are maintained by purchasing. Change implementation is
incorporated into inspection and test records.
6.2. Information relating to customer issued blueprints or other drawings are entered and stored in
the Job Boss computer files. These files show Customer Code Identification, Part number,
Job Number, Job Code Number, and current drawing revision. No additional or separate
Master list is maintained.
6.3. One copy of an obsolete drawing is voided and filed in the VOID drawing cabinet in
Administrative files. The voided copy is stored until such time that the customer issues a new
revision.
7. FORMS
7.1 Form Listing and Revision Status
8. DEFINITIONS
8.1. Drawings - Engineering prints, schematics and artwork
8.2. Documents - Engineering specifications
8.3 Subordinate documents - Manufacturing, test, and inspection procedures or instructions
9. REFERENCE DOCUMENTS
9.1. ISO 9002, paragraph 4.5.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 8
55. PURCHASING QP 103
1. PURPOSE
1.1. This procedure provides specific instructions to ensure that purchased product conforms to
specified requirements
2. SCOPE
2.1. This procedure applies to all suppliers providing materials, parts, or other products purchased
by the NAME OF COMPANY.
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Quality Control
3.2 Administrative Function
3.3 Production Control
4. GENERAL
4.1. The approved suppliers list is initiated, documented, updated, maintained and distributed by
purchasing in conjunction with the Quality Control Function..
4.2. Quality uses the supplier quality performance rating report, surveys, audits and questionnaires
to ensure that the selected suppliers can provide the specified product.
4.3. The approved suppliers list contains the following information:
• Supplier number
• Commodity or Service.
• Method of supplier approval (e.g., supplier surveys).
• Method of supplier approval (e.g., supplier surveys).
4.4. The commodity service that identifies the supplier's capabilities is determined by purchasing
from information supplied by the supplier.
4.5. The method of supplier approval is classified (for purchasing department use) as follows:
• Previous Record - The supplier has a previous record of supplying
high-quality articles of the type being procured. These records are
supported by documentation that includes the supplier history and the
supplier quality performance rating.
• Survey - A survey of the supplier's facilities and quality program has
been performed and accepted. Results of the survey are documented.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 9
56. • Mail - A questionnaire completed by the supplier denoting supplier's
capabilities and quality program has been reviewed and accepted. The
results are documented and on file.
• Temporary - The supplier has only limited qualifications. The
limitations are included in the approved suppliers list.
• Distributor - The supplier is an authorized factory distributor,
contracted to supply commercial or military hardware.
Note: Suppliers not satisfying at least one of the above conditions are referred to the
quality manager for consideration and special provisions.
4.6. Suppliers are removed from the approved suppliers list by the purchasing manager, at the
direction of the quality manager, for the following quality considerations:
• An unacceptable quality performance rating that cannot be resolved.
• An unsatisfactory survey, audit, unanswered corrective action request, or
specific quality problems that cannot be resolved.
4.7. Suppliers are removed from the list at the discretion of the purchasing manager for reasons
other than quality considerations.
4.8. The approved suppliers list is updated or revised every six months by purchasing. Additions,
disapprovals, and corrections are made as the need arises by means of an addendum issued by
purchasing and quality.
4.9. The Administrative Function reviews purchase orders to ensure that Purchasing documents
contain data clearly describing the product ordered as to type, class, grade or other precise
identification. All purchase orders must include the title or other positive identification,
specifications or drawings, process requirements, inspection requirements (where applicable)
and other relevant technical data including approval requirements or qualification of the
product, or procedures.
4.10. The approved supplier list is checked to verify that the supplier specified on the purchase
order is an approved source for the products or services listed. New suppliers must be
approved.
4.11. Contracts requiring government inspection of sub-tier orders are presented to the local
government representatives for review and delegation.
4.12. Copies of acceptable purchase orders are reviewed for accuracy and completeness by the
Administrative Function and a copy of the accepted purchase order is filed in the supplier's
P.O. file.
4.13. Receiving/Inspection follows the P.O. requirements for the necessary inspection
requirements. If on-site inspection of supplier product a requirement of the purchase order,
the Management Representative will contact the supplier and arrange for the inspection to be
carried out. Such verification at supplier premises does not absolve the supplier of supplier
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 10
57. responsibility to provide an acceptable product and cannot be use by supplier as evidence of
effective control of supplier quality.
4.14 The Management Representative provides the pertinent inspection and audit forms to be used
for supplier quality confirmation purposes.
5.PROCEDURE
Responsibility
5.1. Production Control
Action
5.1.1. Accumulates suppliers' names and addresses from a current listing of active suppliers.
5.1.2. Determines commodity and service for each supplier.
5.1.3. Coordinates with the Quality Function to determine the methods of supplier approval
and the quality-level approval.
5.1.4. Reviews Purchasing Documents for adequacy and accuracy of specified requirements.
5.1.5. Ensures that the current revision drawings, specifications and special requirements are
referenced and are applicable to the part number and distribution.
5.1.6. Verifies that the correct quality requirement codes are listed on the purchase order.
5.1.7. Verifies that the supplier specified is on the approved supplier list.
5.1.8. Reviews revised purchased orders.
Responsibility
5.2 Management Representative
Action
5.2.1. Performs surveys and audits of suppliers and views records of past performance to
choose methods of supplier approval and quality-level approval.
5.2.2. Forwards copies of survey results and audits to purchasing with the methods of supplier
approval, the quality-level and memos, if appropriate.
5.2.3. Completes the supplier performance rating report and forwards a copy to purchasing
with recommendations, if any, of suppliers to be disapproved and removed from the
list.
5.2.4. Documents the Approved Suppliers List in Audit XLS.
Responsibility
5.3 Purchasing
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 11
58. Action
5.3.1. Initiates the approved supplier list.
5.3.2. Informs the Management Representative when approved list is revised.
5.3.3. Reviews and revises approved suppliers list when necessary to:
5.3.3.1. Add new suppliers
5.3.3.2. Delete disapproved suppliers
5.3.3.3. Make other corrections
Responsibility
5.4. The Management Representative and Administrative Function
Action
5.4.1. Evaluates suppliers yearly for active production controls.
5.4.2. Amends supplier lists accordingly.
6. RECORDS
6.1. Master copies of the approved suppliers list are maintained by purchasing. The quality
department maintains master copies of supplier quality performance rating reports, surveys,
and audits. Documents pertaining to the Approved Supplier List are maintained for the active
life of the supplier.
7. FORMS
7.1 PFO1-16 SQAAL-Approved Supplier & Audit List
8. DEFINITIONS
8.1. Not applicable
9. REFERENCE DOCUMENTS
9.1. ISO 9002, 4.6.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 12
59. SUPPLIER SURVEY QP 104
1. PURPOSE
1.1. This procedure provides specific instructions for performing surveys and evaluations of
proposed suppliers to ensure the consistency of quality procedures and controls employed by
suppliers.
2. SCOPE
2.1. This procedure applies to all suppliers who provide materials, parts, subassemblies,
assemblies or services.
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Quality
3.2. Purchasing
4. GENERAL
4.1. Each supplier is evaluated before placement of any order. This evaluation is accomplished by
supplier quality and inspection evaluations. The objectives of this evaluation are:
• To establish uniform standards for evaluating the degree and
effectiveness of quality practices and control.
• To identify quality problems for evaluation and correction
• To evaluate various methods of controlling a specific area.
4.2. Suppliers are surveyed and evaluated for the following reasons:
• To qualify a new supplier for future work.
• To evaluate a supplier for specific work before awarding a purchaser
order.
• To evaluate a supplier's capabilities for proposed supplies and services.
• To ensure that a supplier has adequate quality control systems.
• To re-qualify a supplier after one-year lapse in supplier contact.
• To re-qualify a supplier after poor quality performance.
4.3. The purchasing department asks the quality department to perform on-site surveys and
evaluations of suppliers who perform calibration, assembly or test operations to company
drawings or specifications and special processes. The quality department schedules the
survey in coordination with purchasing and the supplier.
4.4. Quality, purchasing and any necessary technically qualified individuals perform the on-site
evaluation of the supplier's facilities and determine the supplier's capabilities. They then issue
a supplier quality and inspection system evaluation report.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 13
60. 4.5. When orders are considered for placement with an unapproved supplier, a supplier quality and
the supplier completes inspection system evaluation report. The form is forwarded to the
supplier by purchasing and reviewed and approved by the purchasing manager and quality
manager before orders are placed with that supplier. Disapproved suppliers may request an
on-site evaluation.
4.6. Noted deficiencies must be corrected by the supplier before the award of a purchase order.
4.7. Re-evaluation of previously qualified suppliers occurs when necessitated by a change in
supplier performance, supplier facility relocation, a change in ownership or changes in
specification or contractual requirements.
4.8. Quality and purchasing review the evaluation report and:
• Approve or disapprove the supplier.
• Publish and update the approved suppliers list, including the approved
Supplier’s name, address, type of service and quality capabilities.
4.9. Each supplier shall be given periodic notice of quality and delivery performance based upon
the supplier’s past performance.
5. PROCEDURE
Responsibility
5.1. Purchasing
Action
5.1.1. Determines the need for a new supplier.
5.1.2. Forwards a questionnaire to the supplier.
5.1.3. Reviews completed questionnaire, approves or disapproves it and forwards it to
quality.
Responsibility
5.2. Quality Department
Action
5.2.1. Enters the questionnaire results in the log, reviews the data and approves or
disapproves it.
5.2.2. Issues an approved suppliers list addendum to list holders.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 14
61. 5.2.3. Forwards the questionnaire results to the purchasing manger for forwarding to the
supplier
5.2.4. Files the questionnaire and any associated documentation by supplier (alphabetically) in
quality records.
Responsibility
5.3. Purchasing
Action
5.3.1. Updates the approved suppliers list if required.
5.3.2. Notifies the supplier of the questionnaire results and any corrective action that is
required before awarding a purchase order.
On-site Evaluations
Responsibility
5.4. Purchasing
Action
5.4.1. Determines the need for a new supplier or the re-evaluation of an old supplier.
5.4.2. Requests an on-site evaluation from quality control.
5.4.3. Coordinates with quality department for additional technical staff.
5.4.4. Coordinates the evaluation with the supplier and quality department.
Responsibility
5.5. Management Representative
Action
5.5.1. Enters the survey request in the log.
5.5.2. Schedules the evaluation visit and assigns personnel to perform the evaluation.
5.5.3. Issues periodic supplier ratings based upon records of supplier’s past performance.
.
Responsibility
5.6. Purchasing
Action
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 15
62. 5.6.1. Accompanies quality personnel performing the survey.
Responsibility
5.7. Quality Department
Action
5.7.1. Performs the evaluation.
5.7.2. Completes the evaluation report and enters the results in the log.
5.7.3. Forwards a copy of the evaluation report with a cover letter listing the evaluation results
as follows:
5.7.3.1. Approves or disapproves the supplier.
5.7.3.2. Issues conditional approval as applicable (i.e., notes that corrective
action is required before approval can be granted).
5.7.4. Reschedules the evaluation, if required.
5.7.5. Issues an addendum to holders of the approved supplier's list.
5.7.6. Files the completed evaluation and any associated documentation by supplier name
(alphabetically) in quality records.
Responsibility
5.8. Purchasing
Action
5.8.1. Updates the approved supplier's list as required.
5.8.2. Forwards a copy of the evaluation results to the supplier along with notice of any
corrective action that must be taken before a purchase order can be awarded.
6. RECORDS
6.1. Supplier quality and inspection system evaluation reports and associated documentation are
filed in the quality department.
6.2. Quality maintains a log of requests for supplier evaluations and evaluation reports.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 16
63. 7. FORMS
7.1. PFO1-13 SQCS - Supplier Quality Control Survey
7.2. PFO1-16 SQAAL – Approved Supplier & Audit List
7.3. PFO1-18 SQAR – Supplier Action Plan Response
7.4. PF01-17 SQES – Supplier on-site Evaluation
7.5. PFO1-21 SQR – Supplier Quality Rating
8. DEFINITIONS
8.1. Special Process
An operation that alters the properties of parts or material. The results of these alterations
(e.g. plating, welding, soldering, and etching) cannot be readily determined by end item
inspection.
8.2. Supplier Level Rating
Supplier level ratings are categorized as follows:
• - E (excellent) - Capabilities exceed requirements in all phases of
• operation.
• - G (good) - Capabilities meet requirements.
• - F (fair) - Good rating on work capability; minor deviation from
quality requirements, but capable of maintaining
acceptable quality.
• - C (conditional) Minor deviations must be corrected before approval,
or past performance requires re-evaluation before
awarding future orders.
• - U (unacceptable) Major deviations make the supplier unacceptable.
9. REFERENCE DOCUMENTS
9.1. ISO 9002, 4.6.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 17
64. CONTROL OF CUSTOMER FURNISHED MATERIAL QP 105
1. PURPOSE
1.1. This procedure provides specific instructions for the control of customer furnished material or
equipment.
2. SCOPE
2.1. This procedure applies to all customer furnished material and equipment used in the
development, manufacture, inspection and test of company products.
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Quality/Assurance
3.2. Production Control
3.3. Shipping and Receiving
3.4 Production Manager
4. GENERAL
4.1. Customer furnished material and equipment is examined by the Receiving Clerk on receipt to
detect damage in transit.
4.2. Customer furnished property is inspected by the Receiving Clerk for completeness, type and
adequacy of documentation.
4.3. Functional testing is conducted by Quality Control before or after installation, or both, as
required by contract or by quality to determine whether operation is satisfactory.
4.4. Precautions are taken by the Receiving Department to ensure adequate storage conditions and
to guard against damage from handling and deterioration during storage. Periodic inspections
are performed.
4.5. Production Control reports to the customer any properly found damaged, malfunction, or
otherwise unsuitable for use, whether upon receipt or in subsequent use. In the event of
damage or malfunction during or after receipt, the company determines and records the
probable cause.
4.6. The Quality Control and Receiving Department provides such identification as property
control or calibration labels, as appropriate.
4.7. The Receiving Department maintains records of all material receipts of customer supplied
product.
4.8. The Quality Control Manager maintains customer record of calibration of customer gages and
is responsible for the return of customer measuring devices when gages are no longer needed
for production purposes.
5. PROCEDURE
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 18
65. Responsibility
5.1. Production Control
Action
5.1.1. Coordinates communication with the customer regarding customer furnished property
requirements.
5.1.2 Provides quality control and the end user with customer furnished
property specifications and requirements.
5.1.3. Administers property records forms when they are required by contract (with support
from the customer.)
5.1.4. Notifies customer when damaged property is received or when property is lost or
otherwise discovered to be unsuitable for the purpose intended. Such notification is
initiated immediately by telephone or fax and documented according to customer
instructions or confirming memoranda.
Responsibility
5.2 Quality Control
Action
5.2.1. Reviews customer-furnished property specifications and requirements to determine any
required action.
5.2.2. Coordinates with the department end-user and prepares, as required, receiving
inspection instructions and test or calibration plans.
Responsibility
5.3. Receiving
Action
5.3.1. Receives customer property and records the date of receipt on documents
accompanying the product.
5.3.2. Notifies Production Control of the receipt of customer property.
5.3.3. Attaches an identification tag showing Customer Name, Part Number and date
received.
5.3.4. Prepares receiving records.
5.3.5. Forwards the property to receiving inspection when operational or dimensional
verification is required.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 19
66. Responsibility
5.4. Production Control
Action
5.4.1. Notifies the customer that property has been received when required by prior
agreement.
5.4.2. Observes the condition of the property as received and unpacked.
Responsibility
5.5. Shipping Manager
Action
5.5.1. Advises Production Control when customer product has been received.
5.5.2. Inspects the property for completeness, type, and damage during transit as well as
completeness of documentation and any other requirements outlined in the shipping
documents.
5.5.3. Fills out property tags and attaches them to customer property that is acceptable.
5.5.4. Forwards the property to the department that will be the custodian of the property (e.g.,
quality assurance, engineering or operations).
5.5.5. Notifies Quality Control when any property is found to be damaged or does not
meet required specifications.
5.5.6. Isolates damaged or otherwise questionable product pending customer notification
and/or final disposition
5.5.7. Delivers the Quality Control Rejection Report and any associated documentation
to Production Control for disposition.
Responsibility
5.6. Production Control
Action
5.6.1. Maintains records pertaining to customer supplied product.
5.6.2. Assigns a property identification, if appropriate, to the customer furnished equipment.
5.6.3. Interfaces with the customer or government property administration representative by
telephone or in person.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 20
67. Responsibility
5.7 Quality Control
Action
5.7.1. Documents and stores customer gages or other measuring equipment
5.7.2. Prepares Inspection Plan where customer product dimensional verification is
appropriate.
Responsibility
5.8 Production Manager.
Action
5.8.1. Ensures that the customer or government equipment identification is preserved.
5.8.2. Ensures that the customer or government equipment is used only as specified in its
contract.
5.8.3. Notifies Production Control if the customer or government property is found damaged,
malfunctioning or otherwise unsuitable for use.
6. RECORDS
6.1. Such records as receiving, inspection, calibrations and maintenance are maintained in
accordance with the customer contract or other customer recommendatrions.
7. FORMS
7.1. Property tag
8. DEFINITIONS
8.1. Customer-furnished property includes consumable material (e.g., raw stock, parts,
subassemblies and assemblies) used in the manufacture of products. It also includes
equipment used for the development, manufacture, inspection or test of products.
9. REFERENCE DOCUMENTS
9.1. ISO 9002, 4.7.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 21
68. PRODUCT IDENTIFICATION AND TRACEABILITY QP 106
1. PURPOSE
1.1. This procedure provides specific instructions pertaining to the identification and traceability
of deliverable products.
2. SCOPE
2.1. This procedure applies to all records that establish trace ability of the various components of
all deliverable products (e.g., raw material, parts, processes, components, subassemblies and
assemblies).
3. DEPARTMENTS RESPONSIBLE FOR IMPLEMENTATION
3.1. Material Handler
3.2. Production Control
3.3. Production Manager
4. GENERAL
4.1. Production Control is responsible for the generation of the necessary documents used to trace
the various components manufactured items. Production Control is also responsible for
preparing special instructions required to implement a specific contract.
4.2. All incoming raw material, purchased parts, and parts subjected to outside special processes
are assigned lot control numbers by Production Control. The numbers are recorded on
acceptance tags that are attached to and remain with the material through the various stages of
storage and fabrication.
4.3. The Material Handler is responsible for the identification, receipt, and storage of raw
materials or finished product used in manufacturing processes.
4.4. The Production Manager is responsible for the proper execution of all traceability documents
during the active production phase.
5. PROCEDURE
General
Responsibility
5.1. Production Control
Action
5.1.1. Reviews the contract quality requirements to determine special trace ability
requirements.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 22
69. 5.1.2. Prepares additional procedures, if necessary.
5.1.3. Specifies trace ability requirements on the purchase orders pass-down, if required.
5.1.4. Issues raw material purchase order to material receiving.
5.1.5. Originates Job Boss computer generated Shop Paper showing part number, number of
parts to be produced, routing of operations, materials required , and additional
information pertaining to the manufacture of the product.
Responsibility
5.2. The Receiving Function
Action
5.2.1. Receives raw materials and checks materials against purchasing specifications.
5.2.2. Stores the material and attaches the identification tag to raw material bin.
5.2.3. Inspects material for size, cracks or other obvious defects.
5.2.4. Delivers material certifications to Production Control when received.
5.2.5. Stores raw material by Bin and Part numbers
5.2.6. Records date and number of bars or bar pounds received on the material purchase order.
5.2.7. Delivers material purchase order to Production Control after completion.
Responsibility
5.3. Production Control
Action
5.3.1. Enters received raw materials in the material receipt log.
Responsibility
5.4. Material Handler
Action
5.4.1. Receives material requirement from Production Supervisor.
5.4.2. Releases material to the machine shop.
5.4.3. Records amount of material issued on the reverse side of the job shop paper located at
the active production site.
Created by Abraham W. Bolden, Sr. January 19, 2001; Posted 4-25-2016 23