FRM 14-004-PR3 REVD 04/15/96 1

General Electric CQST

Common Survey
Checklist
FRM 14-004-PR3 REVD 04/15/96 2
THIS SURVEY CHECKLIST IS COMPRISED OF TWO PARTS:
COMMON SURVEY CHECKLIST, REVISION A , DATED 3/15/94
SURVEY SCORING GUIDELINES, REVISION A , DATED 3/15/94
(First Release)
COMMON SURVEY CHECKLIST, REVISION B , DATED 6/2/94
SURVEY SCORING GUIDELINES, REVISION B , DATED 6/2/94
(Minor updates and improvements)
COMMON SURVEY CHECKLIST, REVISION C , DATED 8/15/94
SURVEY SCORING GUIDELINES, REVISION C , DATED 8/15/94
(Incorporates 1994 revisions to the ISO 9000
Standards)
COMMON SURVEY CHECKLIST, REVISION D , DATED 4/15/96
SURVEY SCORING GUIDELINES, REVISION D , DATED 4/15/946
(Addition of Revision pages)
(All Document pages dated)
THIS SURVEY CHECKLIST HAS BEEN WHOLLY DEVELOPED BY
INTERTEK TECHNICAL SERVICES, FAIRFAX, VIRGINIA.
COMMON SURVEY CHECKLIST
FRM 14-004-PR3 REVD 04/15/96 3
THIS SURVEY CHECKLIST HAS BEEN WHOLLY DEVELOPED BY INTERTEK TECHNICAL
SERVICES, FAIRFAX, VIRGINIA IN COLLABORATION WITH GENERAL ELECTRIC FOR THE
EXCLUSIVE USE OF GENERAL ELECTRIC.
REVISIONS
DATE DESCRIPTION OF CHANGE APPROVED
4/15/96 REV D Addition of Revision Pages
All Document pages dated
8/15/94 REV C INTRODUCTION
Includes provisions for external assessment of a suppliers Quality System.
Servicing is included in ISO 9001 and ISO-9002.
Paragraph numbers are now consistent through all three standards.
Added emphasis that the standards are generic and must be tailored to the
suppliers organization, objectives, products, processes, and practices.
NORMATIVE REFERENCES
Added a paragraph which states that other standards referenced in the
text of this standard constitute provisions of this standard.
DEFINITIONS
Added paragraph 3.2 (formerly a note) and expanded the definition of
product to include hardware, software, processed material, and service
Excludes unintended product which was incorporated into ISO 8402
QUALITY SYSTEM REQUIREMENTS
Standardized the wording throughout the standard for procedure requirements,
viz ... establish and maintain documented procedures
4.1.1 QUALITY POLICY
Added the sentence: The quality policy shall be relevant to the
suppliers organizational goals and the expectations and needs of its
customers.
4.1.2.1 RESPONSIBILITY AND AUTHORITY
Expanded paragraph a) to include process and quality system
nonconformities.
Expanded paragraph b) to include process and quality system
problems.
4.1.2.2 RESOURCES
Application broadened beyond verification resources to include
management
and performance of work.
4.1.2.3 MANAGEMENT REPRESENTATIVE
Added a member of its own management to the first paragraph.
Paragraph b) added the requirement for the management
representative to report
on the performance of the quality system.
Added a note relating to liaison with external bodies.
4.1.3 MANAGEMENT REVIEW
Management review of the quality system must now ensure that the
quality
policy, goals, and objectives are being met.
4.2 QUALITY SYSTEM
Paragraph 4.2.1 now requires a quality manual.
Paragraph 4.2.2 requires preparation of procedures which are consistent with the
stated quality policy.
Paragraph 4.2.3 requires quality planning.
Sub-paragraphs a) through h) formerly were notes and now are requirements,
with the exception of f) which is a new requirement.
FRM 14-004-PR3 REVD 04/15/96 4
4.3 CONTRACT REVIEW
Clarified the requirements for review of verbal contracts by adding the words
accepted order in paragraph 4.3.2 and sub-paragraphs a), b), and c).
Paragraph 4.3.3 added requirements for identifying how amendments to
contracts are made and effectively communicated.
Note 1 was reworded and note 2 provides a definition of contract or accepted
order.
4.4 DESIGN CONTROL
In paragraph 4.4.4, the clause ...including applicable statutory and regulatory
requirements... was added (previously in design output).
Added a sentence requiring contract review activities be considered as design
input.
Added paragraph 4.4.5 for design review. Design reviews have fundamentally
changed to include review by all functions concerned with the design.
Paragraph 4.4.6c) clarified to show that crucial characteristics apply to those
which involve customer use.
Added paragraph 4.4.6d) to include a review of design output documents before
release.
Added paragraph 4.4.7d) to include a review of the design stage documents
before release.
Added paragraph 4.4.8 for design validation.
Added the requirement that design changes be reviewed and approved before
their realization in paragraph 4.4.9.
4.5 DOCUMENT AND DATA CONTROL
Paragraph 4.5.1 includes the requirement to control external documents such as
standards and customer drawings.
A note states that electronic and other media are applicable.
Paragraph 4.5.2c) added requirement to identify obsolete documents retained for
historical purposes.
4.6 PURCHASING
Added the requirement for documented procedures to paragraph 4.6.1.
Added the phrase to paragraph 4.6.2.6 ...the impact of sub-contracted product
on the quality of final product...
Paragraph 4.6.4.1 added requirements to specify verification arrangements and
the method of product release in the purchasing documents.
4.8 PRODUCT IDENTIFICATION AND TRACEABILITY
Added requirements for product identification from receipt through
production, delivery, and installation.
4.9 PROCESS CONTROL
Added :servicing to the process control requirements.
Changed work instructions to procedures in paragraph 4.9a).
Added paragraph 4.9g) for maintenance of equipment.
Added the phrase ...carried out by qualified operators... to special process
requirements.
Added a paragraph to include the requirements for qualification of process
operations.
4.10 INSPECTION AND TESTING
Added paragraph 4.10.1 to require documented procedures for inspection and
testing activities.
Paragraph 4.10.2.2 was a note in the 1987 version, now a requirement.
Deleted identify nonconforming product from 4.10.3 and added where the
product fails to pass any inspection and/or test, the procedures for control of
nonconforming product shall apply. (see 4.13). to paragraph 4.10.5.
Moved the sentence from 4.12 which states records shall identify the inspection
authority responsible for the release of product.
FRM 14-004-PR3 REVD 04/15/96 5
4.11 CONTROL OF INSPECTION, MEASURING,
AND TEST EQUIPMENT
Added paragraph 4.11.1 which requires documented procedures to control,
calibrate, and maintain inspection, measuring, and test equipment.
Reorganized, reworded, rearranged, and clarified the various elements for
required procedures.
Added control to the title.
4.12 INSPECTION AND TEST STATUS
Deleted the examples of suitable means for identifying the inspection and test
status.
Inspection and test status must now be maintained throughout servicing, as well
as production and installation.
4.14 CORRECTIVE AND PREVENTIVE ACTION
Separated corrective action and preventative action for clarification.
Paragraph 4.14.1 added the phrase ...appropriate to the magnitude of
problems...
Added paragraph 4.14.2a) for handling customer complaints.
Added paragraph 4.14.2b) for investigating the cause of nonconformities
relating to product, process. and quality system and recording results as quality
records.
Added paragraph 4.14.2c) for root cause analysis of nonconformities.
Added paragraph 4.14.3b), c), and d) for preventive action.
4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION, AND DELIVERY
Added paragraph 4.15.5 for preservation and segregation of product.
4.16 CONTROL OF QUALITY RECORDS
Added access requirements for quality records.
4.17 INTERNAL QUALITY AUDITS
Added the requirement for defining the process of planning internal quality
audits.
Internal quality audit records are now definitely quality records.
Follow-up audits must record the implementation and effectiveness of corrective
action and they become quality records.
4.18 TRAINING
Added the word documented.
4.19 SERVICING
Added requirements for reporting on servicing requirements.
4.20 STATISTICAL TECHNIQUES
Deleted where appropriate and added ...identify the need...
Reorganized the clause to identify the need for statistical techniques and then
establish procedures to implement and control them.
SUPPLIER PROFILE
COMPANY NAME _Abastecedora de Aceros y Maquilas S.A. De C.V._____________
DIV/GRP ____________________________________________
STREET __Ave Benito JuarezKm 7.5,
CITY & STATE __Guadalupe, N.L. Mxico________________________
TELEPHONE (81)8360-0414, (81) 8360-0513
TYPE OF PRODUCT(S) ___Steel Laser Cutting
TOTAL PLANT AREA (SQ.FT.) __________________________
#. OF BUILDINGS ____________________________________
TOTAL # OF EMPLOYEES ____________________________
# OF QUALITY DEPARTMENT EMPLOYEES ______________
# OF MANUFACTURING EMPLOYEES ___________________
DATE ____________________________________________
d/m/y
ZIP CODE________________67190________________
FAX ( )_______________________________________________
NAME(S) OF OTHER FIRMS WHICH APPROVED THIS
FACILITY/SYSTEM
_______________________________________________________
_______________________________________________________
NAME(S) OF OTHER FIRMS DOING BUSINESS WITH THIS
COMPANY
Caterpillar y John Deere
_____________________________________________________
THE NAMES OF THE COMPANY EXECUTIVES ARE:
PRESIDENT ___________________________________
VICE PRESIDENT ______________________________
QUALITY MANAGER _____________________________
MFG. MANAGER ________________________________
THIS COMPANY'S QUALITY SYSTEM IS DESIGNED TO:
(a) MIL-Q-9858 ___________________________
(b) MIL-I-45208 __________________________
(e) OTHER (SPECIFY) __________________________
LIST THE SPECIAL PROCESSES THIS COMPANY PERFORMS IN-HOUSE AND THOSE IT SUBCONTRACTS.
IN-HOUSE
______________________________________________________
______________________________________________________
______________________________________________________
SUBCONTRACT
_______________________________________________________
_______________________________________________________
_______________________________________________________
BIS QMS
SURVEY CONDUCTED TO: PQP
TOTAL POINTS AWARDED:
RATING: (0-100)
ISO 9000 READINESS: _____ CERTIFIED OR PLANNED
_____ CAPABLE WITH IMPROVEMENT
_____ FOUNDATION IN PLACE
_____ MAJOR EFFORT REQUIRED
SUMMARY:
SURVEYED BY:
SUPPLIER QUALITY SYSTEM SURVEY
1.0 General Instructions
In conducting a supplier survey you will be performing a function critical to
both General Electric and the supplier. Your objective is to clearly
understand and document the capabilities of the supplier's quality system.
2.0 Survey Pre-planning
Survey preparation should include the review of all available information
on the supplier's past performances, open corrective actions, and special
review items.
2.1 Supplier Contact
Contact the supplier and agree on a date to conduct the survey that meets
GE's requirements and the
supplier's schedule. During this contact notify the supplier that a survey
will be sent for use in a selfassessment
that should be completed prior to your survey. Request any necessary
information such as
quality plans, SPC data, etc.
3.0 Conducting the Survey
Begin the survey by leading a formal kick-off meeting with the supplier's
management and quality
representative. Be sure to overview the survey approach and discuss
administrative, facility, and support
needs. Clearly indicate the need for supplier participation during the
survey.
3.1 Survey Checklist
Evaluate the supplier's quality system using the requested checklist
questions, BIS, QMS or PQP. The
supplier rating sheet indicates which sections of the checklist are required
for each of the quality system
assessments.
The questions listed in each section should be used as a guide to
determine the supplier adequacy and
compliance. The supplier's representative should be directly involved
during the assessment to assure all
information is reviewed.
3.2 Debriefing and Final Report
Prepare and discuss final observations with the supplier's management
team. Discuss all corrective action
requests as well as the observed system strengths. Be sure to leave the
supplier a copy of the survey
results and corrective action requests.
SUPPLIER RATING WORKSHEET
FRM 14-004-PR3 REVD 04/15/96 8
Points Awarded
Basic
Inspection
System
Quality
Management
System
Preferred
Quality
Program
Max
Score
SUBSECTION
REQUIREMENTS
13 4.1 Management Responsibility
8 4.2 Quality System
6 4.3 Contract Review
10 4.4 Design Control
7 4.5 Document and Data Control
8 4.6 Purchasing
2 4.7 Purchaser Supplied Product
7 4.8 Product Identification & Traceability
10 4.9 Process Control
11 4.10 Inspection & Testing
10 4.11 Inspection/Measuring, & Test Equipment
4 4.12 Inspection & Test Status
10 4.13 Control of Nonconforming Product
10 4.14 Corrective Action
2 4.15 Handling, Storage, Packaging & Delivery
4 4.16 Control of Quality Records
8 4.17 Internal Quality Audits
11 4.18 Training
8 4.19 Servicing
16 4.20 Statistical Techniques
4 4.21 Cost of Quality Program
13 4.22 Customer Orientation
8 4.23 Continuous Process Improvement
10 4.24 Total Quality Management
200 TOTAL POINTS AWARDED
| | | SUPPLIER RATING
| | | PQP
| | (_________ 200 )X 100 = ____________
| | QMS
| (_________ 165 )X 100 = ____________
| BIS
(_________ 155) X 100 = ____________
Definitions: 95 - 100 Outstanding Supplier, ISO-9000 Certification Suggested
80 - 94 Qualified, Strong ISO-9000 Foundation
71 - 79 Marginal, Additional Surveillance Required
70 & Below Poor, Significant Corrective Action Required
AUDIT AREAS COVERED
(Topics/Questionnaires) Y N N/A Remarks
4.1 MANAGEMENT RESPONSIBILITY (Assigned Max Score: 13)
An overall upper management policy, attitude and total commitment
towards quality and everything related to it.
Has the management defined its objectives and commitment to quality?
Support Questions:
Has the management adequately allocated its resources for quality?
Does the management at its highest level give full support and backing
to quality?
4.1.1 Quality Policy
Is the quality policy expressed in language which is easy to understand
and follow?
Is the quality policy well written and documented, and is it covering all
important related areas?
Compliant
Does the quality policy support measurements related to company goals
and customer needs?
Support Questions:
Does the quality policy ensure that the organization's people
understand, implement and follow quality standards at all levels of
organization?
Is the quality policy reviewed periodically by the management to keep it
current and up-to-date?
4.1.2 Organization
Is everyone in the organization made responsible for achieving the quality
objectives and requirements?
Support Questions:
Does the organization designate one or more individuals to monitor and
report the quality achieved?
Do these designated individuals have access to the highest levels of
management in the organization?
4.1.2.1 Responsibility and Authority
Is the responsibility and authority of all personnel monitoring quality clearly
defined?
Support Questions:
Does the organizational chart clearly state and verify this responsibility
and authority?
Do the individuals with responsibility and authority have the necessary
freedom to perform their functions without interference from other
departments?
4.1.2.2 Resources
Does supplier management allocate adequate resources and personnel
for achieving its goals and objectives during production and verification?
Support Questions:
Are standards and arrangements in place for production and
verification?
Are individual(s) skilled and well trained to perform production and
verification?
Is sufficient time allowed to do the work?
Is necessary equipment available for production and testing?
Are documented procedures prepared and up-to-date?
Do verification activities include inspections, testing and monitoring the
effect on quality at every level?
Do individuals performing production and verification have access to all
quality records?
Do they have access to the highest management level for objectiveness?
Are process flow charts used as a tool for quality planning?
4.1.2.3 Management Representative
Has a management representative been appointed with defined authority
and responsibility to ensure that the requirements of the quality system
are implemented and maintained?
Is this the same individual who reports on quality system performance?
Is this representative, irrespective of other responsibilities, able to perform
his/her duties with no conflict of interest?
4.1.3 Management Review
Does management periodically review the appropriateness of the quality
system and requirements?
Support Questions:
Does the organization clearly understand the reasons behind this
review?
Does this review include, but is not limited to, the organization's
structure, staffing and resources?
Are results documented and analyzed for trends which may indicate
systematic problems?
Are these review results discussed with the individual concerned?
Does management assure the environment and working conditions are
conducive to quality?
Does this review insure that quality goals and objectives are being met?
4.1 Subtotal: (Assigned Max Score: 13)
4.2 QUALITY SYSTEM (Assigned Max Score: 8)
A Quality system consists of thoroughly and well defined documented
procedures and quality plans, which describe the organization, authority,
responsibility, verification activities, and various functions of personnel in
that organization.
Has a documented quality system been established and maintained?
Are quality organizations authorities and responsibilities clearly defined in
writing?
Is the quality system documented by means of a quality manual?
Does this documentation define clearly the complete quality system?
Support Questions:
Is this document current and up-to-date?
a) Has a quality organization been established and in place?
b) Does quality organizations personnel understand, use, and implement
this document?
c) Does the quality organization prepare and issue reports and maintain
records relative to item acceptance, rejection and disposition of rejected
items?
Is there a system for continual maintenance and updating of a quality
manual?
a) Does inspection system cover all supplies and services offered for
acceptance?
b) Does supplier inspection system cover all supplies procured from
outside suppliers?
c) Does this inspection system assure all supplies submitted for
acceptance conform to contract requirements?
Are all tests and inspections documented?
a) Is all documentation available for customer and/or government review?
b) Do suppliers notify the customer in writing of all changes to the
system?
c) Do suppliers comply with all customer decisions concerning (system)
changes?
d) Have quality planning activities been documented?
e) Are quality plans in place for each product category?
Do these plans identify suitable testing at appropriate stages?
a) Have QC activities been updated to reflect improved technology?
b) Have product acceptance standards been studied in order to reduce
subjectivity?
c) Is quality planning an ongoing or periodic occurrence rather than one
time?
4.2 Subtotal: (Assigned Max Score: 8)
4.3 CONTRACT REVIEW (Assigned Max Score: 6)
Contract review is an important function performed to review the
requirements of the contract under established written procedures
.
Does supplier have established written procedures for contract review?
Does the supplier's purchasing organization coordinate all contract review
activities such as interfaces and communication with the customer?
Support Questions:
Does the review process ensure:
a) The requirements are adequately defined and documented?
b) Any requirements differing from tender are addressed and resolved?
c) The supplier has the capability to meet the contractual requirements?
Are all records of contract review maintained?
Does the contract review procedure include details of quality
requirements?
Does the contract review procedure include delivery schedule,
packaging requirements?
Does the review include the penalties for delivery of nonconforming
material?
Does the contract review procedure have the following features:
a) All interested parties have an opportunity to review the contract?
b) A draft quality plan, if appropriate, has been developed?
c) A checklist or some other means to address all important elements of
the contract?
d) A thorough discussion among all parties for questions and answers
through the reviewing process?
e) Documentation and approval of any verbal arrangements are on file?
4.3 Subtotal: (Assigned Max Score: 6)
4.4 DESIGN CONTROL (Assigned Max Score: 10)
A documented and systematic method applied to administer and control
the entire spectrum of design activity.
4.4.1 General
Have procedures been established and maintained to control and verify
the design of the product?
Does this document ensure that the specified requirements are met?
4.4.2 Design and Development Planning
Does the supplier have established procedures for design and
development planning?
Support Questions:
Does this procedure address the following:
a) Sequential and parallel work schedules?
b) Design verification activities?
c) Plans for evaluating the safety, performance and dependability
incorporated in the product design?
d) Plans for methods of product measurement, test, and acceptance
criteria?
e) Assignment of responsibilities?
f) Integration with other plans and verification procedures for the
implementation of the contract?
g) Are these plans and procedures updated as the design evolves?
4.4.2.1 Activity Assignment
Has the supplier assigned responsibilities for design work to designated
personnel?
Support Questions:
Are these personnel qualified and experienced?
Do they have access to information and resources to complete the
work?
Is this activity adequate to verify that the design meets the requirement?
4.4.3 Organizational and Technical Interfaces
Are pertinent responsibilities and authorities defined, documented,
coordinated and controlled interfaces with other organizations?
Support Questions:
Is there a written procedure which defines when other organizational
functions contribute to the design process?
What other organizations participate, and how?
4.4.4 Design Input
Has the supplier prepared a design description document?
Support Questions:
Does this document identify design aspects, material and processes?
Does it require prototype testing to verify the adequacy?
Does it quantify all requirements to the greatest possible extent?
Does it provide a unified approach to the design?
Does this document define performance, functional, descriptive,
environmental, safety and regulatory aspects?
Is this document kept up-to-date as the design progresses to
completion?
Does this document include the results of contract review activities?
4.4.5 Design Review
Have appropriate stages been identified in writing for conducting design
reviews?
Do design reviews include all concerned functions (sales, quality,
engineering, purchasing, etc.)?
Are design review plans and records documented?
4.4.6 Design Output
Has the supplier prepared a design output document which contains the
following descriptions:
a) Drawings?
b) Specifications (including process and material specifications)?
c) Instructions?
d) Software (if applicable)?
e) Servicing (if applicable)?
Does the design output document identify crucial characteristics (those
that significantly affect safety or proper functioning of the product)?
Support Question:
Does the design output exhibit how the purchasing, production,
installation, inspection and testing incorporate the design input
requirements?
Have considerations such as operating, handling, and maintenance
been addressed?
Are design output documents reviewed prior to release?
4.4.7 Design Verification
Has the supplier planned, established, documented, and assigned to
competent personnel the functions for verifying the design?
Does this document include the design reviews, qualification tests,
alternative calculations and a comparison with a proven design (if any)?
Support Questions:
Does the design verification process consider the following questions:
a) Do designs satisfy all specified requirements?
b) Are product design and processing capabilities compatible?
c) Are safety and reliability considerations covered?
d) Have appropriate materials and/or services been selected?
e) Is the design satisfactory for all anticipated environmental and load
conditions?
f) Can the tolerance requirements consistently be met?
g) What are the assumptions made during the design process and what is
their validity?
4.4.8 Design Validation
Is the design validated against user needs?
Support Questions
Does design validation follow successful design verification?
Have product "users" been defined?
Is this definition complete?
Have user needs been established?
Is there objective evidence that these represent the actual needs?
Does the validation process ensue the fulfillment of user needs?
4.4.9 Design Changes
Have the procedures been established to communicate the new design
output to all concerned, to record any design changes, and to document
that only authorized design changes have been made?
Support Questions:
Is the verification procedure reviewed and modified when significant
design changes are made?
Are design changes in one component of a product evaluated for their
influence on the whole?
Does supplier identify and review any design changes to determine
whether they influence previous design verification results?
Are design changes approved and issued prior to their realization?
4.4 Subtotal: (Assigned Max Score: 10)
4.5 DOCUMENT AND DATA CONTROL (Assigned Max Score: 7)
Document Control is an organized process to control and maintain all
documentation and data within an organization.
4.5.1 General
Are procedures in place for controlling all documents and data related to
compliance with customer requirements?
Support Questions:
Do document control procedures address how to control the details of
customer drawings, industry standards, and computer data?
4.5.2 Document Approval and Issue
Have procedures been established for the review, approval and issue of
all documents and data?
Support Questions:
Does the supplier's system provide clear and precise control of
documents and responsibilities for approval, issue, distribution and
removal of obsolete documents?
Are these responsibilities understood and practiced by the personnel?
Are obsolete documents stamped as such?
4.5.3 Document Changes/Modification
Has the supplier established a continuing mechanism for controlling
changes in documentation?
Support Questions:
Are these changes documented?
Does the document ensure accurate updating?
Are all concerned personnel informed when changes take place?
Does the system provide for using only authorized documents when
implementing changes?
Are all change/modification records maintained?
4.5 Subtotal: (Assigned Max Score: 7)
4.6. PURCHASING (Assigned Max Score: 8)
A function of procuring all products and services from outside suppliers
under documented and established procedures and guidelines.
4.6.1 General
Have procedures been established and maintained for procurement of all
products and services?
Does the supplier ensure that purchased product conforms to specified
requirements?
4.6.2 Assessment of Sub-Contractors
Have procedures been established and maintained for the selection and
monitoring of sub-contractors?
Support Questions:
Does supplier employ a system through written procedures to assess
the sub-contractor's quality systems?
Do the supplier's quality records sufficiently demonstrate the ability of
sub-contractors to meet the specified quality requirements?
Is the performance of sub-contractors reviewed at regular intervals?
Are historical data being compiled and maintained for all subcontractors'
performances concerning quality, delivery, cost, and certification to
specification?
Does the level of control over sub-suppliers depend upon the impact of
supplied product on the finished product?
Do sub-supplier control levels depend on previously demonstrated
capability, such as through supplier audits or process capability studies?
4.6.3 Purchasing Data
Does the supplier's purchasing documents define clearly and precisely the
requirements to ensure the quality of the products?
Do well-defined purchase orders provide the documented evidence for
quality requirements?
Are purchase orders reviewed and approved for adequacy, correctness
and completeness of specified requirements prior to release?
4.6.4 Verification of Purchased Product
Is an established procedure in place for verification of purchased product?
Support Questions:
Does the supplier specify source verification requirements and the
method of product release in its purchasing documents?
Does the supplier have written procedures to administer and control
source inspection at sub-contractor's facility?
Are source inspection records being maintained?
Does supplier maintain a well established and documented receiving
inspection function?
4.6 Subtotal: (Assigned Max Score: 8)
4.7 PURCHASER SUPPLIED PRODUCT (Assigned Max Score: 2)
A product or service provided by the customer to its supplier under
contract to help and facilitate the supplier's efforts to manufacture the
desired end product.
Have procedures been established and maintained for verification of
purchaser supplied products?
Support Questions:
Is the product being examined, inspected or tested for quality?
Is the product being examined for quantity received, its identity and any
damage in transit?
Is a periodic inspection performed during storage to detect any signs of
deterioration?
Are proper methods used for identification and safeguarding of the
supplied product to prevent unauthorized use?
Is a system in place to notify purchaser of any damaged or
unacceptable product being supplied?
Does the supplier take full responsibility for the maintenance and
effectiveness of the purchaser supplied product?
Does the process assure that all customer supplied material and parts
are identified?
4.7 Subtotal: (Assigned Max Score: 2)
4.8 PRODUCT IDENTIFICATION AND TRACEABILITY (Assigned Max Score: 7)
An established system to identify and trace the product during all phases
of manufacturing and inspection.
Have procedures been established and maintained for identifying the
product and its traceability?
Support Questions:
Are proper methods being employed for positive identification, such as
tagging, serial number, color coding etc?
Are the containers, batches, or lots properly identified?
Is a positive identification being maintained during all stages of storage,
production, inspection, delivery and installation?
Is traceability maintained by means of recorded identification?
Could this traceability be traced back from finished product to raw
material?
Are the traceability requirements thoroughly examined during the review
of the contract?
Can this traceability also identify the personnel performing different
operations at various stages?
Are all parts and materials positively identified immediately following
receipt?
4.8 Subtotal: (Assigned Max Score: 7)
4.9 PROCESS CONTROL (Assigned Max Score: 10)
Specific requirements to plan and control processes
4.9.1 General
Have procedures been established and maintained for monitoring the
variation in processes?
Is the control within the process adequate to prevent non-conformities
from occurring?
Do procedures describe methods for accepting materials or items into the
process?
Are they being characterized while in the process?
Is the adequacy of measurement processes considered in assessing the
adequacy of the process control?
Are equipment maintenance procedures in place and can the supplier
demonstrate that they are sufficient to ensure continued process
capability?
Support Questions:
Are statistical process control methods employed for monitoring the
process?
Are consistent and stable operating conditions maintained for the
process equipment and essential materials?
Are these equipments calibrated employing documented procedures?
Are the characteristics which are most critical to the product quality
(including service) identified and applied to the process control?
Are all records being kept and maintained for the entire operation under
process control?
Are servicing processes subjected to these process control
requirements?
4.9.2 Special Processes
Processes that result in product quality characteristics that cannot be fully
verified in the product until the product is in use.
Are there written procedures and methods established and maintained for
the operation and monitoring of results for special processes?
Has the supplier identified and planned to carry out the operation of these
special processes which directly effect the quality?
Support Questions:
Do the procedures and methods ensure that these processes are
carried out under controlled conditions?
Is the approval of processes and equipment being thoroughly planned
and reviewed against specific criteria?
Are records maintained for these special processes, and equipment?
Are qualified and skilled personnel utilized to carry out these operations?
Are the criteria set for product acceptance?
Is there a control plan documented for customer approval of all changes
to these processes?
Are records maintained for all changes and approvals to these
processes?
4.9 Subtotal: (Assigned Max Score: 10)
4.10 INSPECTION AND TESTING (Assigned Max Score: 11)
Well documented and established procedures describing in detail the
methods, and monitoring functions of all facets of inspection & testing
criteria.
4.10.1 Receiving Inspection and Testing
Have the procedures or plans been established and maintained for all
receiving inspection activities?
Support Questions:
Does the plan include acceptance criteria, equipment and
documentation to be used?
Does the plan ensure that all incoming items/products are not used until
examination, inspection, or testing has been performed?
Does the supplier inspect/test incoming material from suppliers?
Is evidence available documenting the results of all inspections and
tests?
Does the system require the segregation of uninspected, accepted, and
defective material?
Are all receiving inspection results and records systematically filed and
maintained?
4.10.2 In-Process Inspection and Testing
Has the supplier documented procedures or quality plans for inprocess
inspection and testing?
Support Questions:
Does the plan allow early recognition of non-conformities and timely
disposition of the product?
Are statistical control techniques used to identify trends for both process
and product before non-conformities actually occur?
Are the in-process inspection or testing results and records being filed
and maintained?
Is sufficient in-process inspection and/or testing conducted to detect
process changes or defective items prior to completion?
4.10.3 Final Inspection and Testing
Have the procedures or plans been established and maintained for the
final inspection/ testing of finished product prior to shipment to customer?
Support Questions:
Are final products inspected and identified as required by the
inspection/test plan?
Are all final inspection records being kept and maintained?
Is all documentation complete?
Are inspection/testing records available for review by the customer as a
positive evidence that all required inspection/testing has been performed?
4.10.4 Inspection and Test Records
Do supplier's inspection and test records facilitate assessment of having
fulfilled the requirement?
Is helpful supporting evidence available from records of other inspections
and testing (i.e., raw material, in-process etc.)?
Are inspection and testing records being kept and maintained to meet the
regulatory and liability requirements, if applicable?
Do these records indicate whether the product passed or failed?
4.10 Subtotal: (Assigned Max Score: 11)
4.11 CONTROL OF INSPECTION, MEASURING AND
TEST EQUIPMENT (IM&TE) (Assigned Max Score: 10)
A documented system describing the control, calibration, and
maintenance for all inspection, measuring, and test equipment.
Have documented procedures or plans been established and maintained,
specifying the acquisition, maintenance and calibration of all inspection,
measuring and test equipment?
Have statistical methods, such as gage R&R, been reviewed and planned
for both product and process measurement systems?
Does the supplier employ methods which demonstrate the conformance
of product measurement, inspection and testing to the specified
requirements?
Support Questions:
Do the methods ensure that the IM&TE is capable of the accuracy and
precision necessary?
Are all necessary records being kept for maintenance, storage and
calibration for IM&TE?
Are all these records available for the customer's review and approval?
Does the calibration system include recall schedules?
Are primary standards traceable to NIST or equivalent?
Are calibration stickers used?
Are personal tools in the calibration system?
Is there a procedure to properly disposition out-of-tolerance equipment?
4.11 Subtotal: (Assigned Max Score: 10)
4.12 INSPECTION AND TEST STATUS (Assigned Max Score: 4)
A documented verification method and procedures to identify which
products have been inspected, accepted or rejected at any given time.
Has a documented procedure been established for the verification of
inspection and test status?
Support Questions:
Does the quality system ensure that all required inspections and tests
are performed?
Does the system indicate whether a product has been inspected, tested,
accepted, rejected, or is on hold by means of marking, recording, tagging,
or any other suitable means?
Are separate physical locations of these categories maintained to know
the status at all times?
Are all pertinent records maintained from raw material inspection to final
and finished product?
Do test status requirements apply fully to production, installation, and
servicing?
4.12 Subtotal: (Assigned Max Score: 4)
4.13 CONTROL OF NON-CONFORMING PRODUCT (Assigned Max Score: 10)
A documented system and methods which describe how to control and
segregate the product(s) which does not conform to specified
requirements and its disposition.
4.13.1 Non-Conformities Review and Disposition
Are procedures established and maintained to ensure that product that
does not conform to specified requirements is prevented from use or
installation?
Support Questions:
Is control provided for identification, documentation, evaluation,
segregation, and appropriate disposition of non-conforming product?
Is the non-conformity reviewed, evaluated and causes determined to
prevent recurrence?
Are all important records maintained concerning non-conformities for
the customer's review?
4.13 Subtotal: (Assigned Max Score: 10)
4.14 CORRECTIVE AND PREVENTIVE ACTION (Assigned Max Score: 10)
A documented, methodical and systematic approach to correct processes
or products which do not, or potentially may not, meet the specified
requirement.
Have procedures been developed by the supplier to establish
responsibility for taking corrective and preventive actions?
Does it describe how the actions will be carried out? Does it show the
verification of the effectiveness of corrective and preventive actions?
Does the supplier have a process to investigate and analyze all processes
to deter actual or potential nonconformities, and is related corrective or
preventive action taken to prevent recurrence or occurrence?
Support Questions:
Does supplier apply sufficient controls to ensure that effective corrective
or preventive actions are taken?
Have all corrective and preventive actions taken been recorded and
documented?
Does the supplier interface and notify the customer about initiating
corrective and preventive actions?
Does the supplier measure time taken for corrective action
(promptness) and consistently meet customer's requirements?
Does the supplier record all customer complaints?
Are priorities given to large magnitude or high-risk problems?
Does the supplier fully utilize such information sources as service
reports, returns, and warranties to detect potential nonconformities?
Is a root cause analysis method in place to conduct investigations?
4.14 Subtotal: (Assigned Max Score: 10)
4.15 HANDLING, STORAGE, PACKAGING AND DELIVERY (Assigned Max Score: 2)
A systematic and documented method applied for handling, storage,
packaging and delivery requirements for the product being manufactured
4.15.1 General
Does supplier have a documented procedure and system for handling,
storage, packaging and delivery?
Does this system include incoming materials, materials in process, and
finished product?
4.15.2 Handling
Does the supplier have an effective method of handling materials?
Does this method consider provision for transportation units such as
pallets, containers, conveyors, vessels, or other means to prevent
damage, deterioration, or contamination?
Are all other factors considered during handling of materials such as
vibration, shock, corrosion, temperature, radiation, etc.?
Are all handling equipments properly maintained and stored?
4.15.3 Storage
Does the supplier have suitable and safe storage facilities?
Are these storage facilities appropriate for environmental conditions such
as temperature and humidity?
Does this system address handling, storage, etc., of ESD devices?
Is there a method or system to check items in storage periodically to
detect possible deterioration?
Are administrative procedures established for expiration dates, marking,
labeling of the product in storage?
Are all appropriate records maintained for the product in storage?
4.15.4 Packaging
Does the supplier have a packaging procedure or system that provides
appropriate protection against damage?
Does this system provide designs and plans for suitable materials,
packaging, and labeling against damage and deterioration during storage,
and transportation?
Does the packaging provide a clear description of the content where the
regulations or the contract specify?
Are ESD, Electrostatic sensitive devices properly packaged?
4.15.5 Delivery
Does the supplier provide protection for the quality of product during
shipping and other phases of delivery?
Is delivery time and means of transportation planned?
Prior to shipping product to customer, does supplier have adequate
controls to ensure that identification labels are correct, properly located
and attached?
4.15 Subtotal: (Assigned Max Score: 2)
4.16 CONTROL OF QUALITY RECORDS (Assigned Max Score: 4)
A documented, established system for controlling and maintaining all
pertinent quality records and data.
Have procedures been established and maintained for the control and
retention of all quality records?
Support Questions:
Does the procedure include the quality records of all subcontractors?
Do the records provide objective evidence that all required inspection
and testing has been performed?
Are quality records made available for review and evaluation by the
customer?
Has retention time of quality records been established and recorded?
Do procedures state responsibilities for retention?
Do procedures state who has access to records and how they gain that
access?
4.16 Subtotal: (Assigned Max Score: 4)
4.17 INTERNAL QUALITY AUDITS (Assigned Max Score: 8)
A documented system to perform internal quality audits to assess how the
established quality system is functioning.
Has a documented procedure been established and maintained which
outlines the planned and systematic approach for internal quality audits?
Support Questions:
Is the procedure adequate to determine the effectiveness of the
implemented quality system?
Does it provide an opportunity to improve the supplier's quality system?
Has the interval time been set to perform the internal quality audits?
Are these audits performed by competent personnel with objectivity?
Are all records maintained for internal quality audits?
Is prompt action taken to correct the deficiency found in quality system?
Have the audits and follow-up actions been carried out in accordance
with documented procedures?
Are all internal audit records being maintained and available for
customer's review, if requested?
Has the audit planning process been defined in writing?
Are internal audit records and follow-up audits identified as quality
records?
Do follow-up audits record explicitly the implementation and
effectiveness of corrective action?
4.17 Subtotal: (Assigned Max Total: 8)
4.18 TRAINING (Assigned Max Score: 11)
A management approach to continually train personnel for
enhancing the quality system.
Have procedures been established and maintained for identifying the
needs for all personnel performing activities affecting quality?
Support Questions:
Is specific training provided for personnel to perform assigned tasks?
Is this training adequate for the personnel in the usage of procedures
and documents?
Does the training system evaluate the general education, experience
and proficiency of the personnel for the activities to be performed?
Does the training system plan, organize, and carry out appropriate
training programs either in-house or by an outside body?
Are all training and achievement records regularly reviewed and
properly maintained?
4.18 Subtotal: (Assigned Max Score: 11)
4.19 SERVICING (Assigned Max Score: 8)
The supplier's policy and documented guidelines to meet the servicing
requirements of the contract
Where servicing is specified in the contract, have procedures been
established and maintained for performing, reporting, and verifying the
servicing?
Does the procedure for servicing include the following:
Planning of service activities?
Control of measuring and test equipment used in field servicing and
testing?
Training of servicing personnel?
Feedback of information from servicing personnel that would be useful
for improving product and servicing design?
4.19 Subtotal: (Assigned Max Score: 8)
4.20 STATISTICAL TECHNIQUES (Assigned Max Score: 16)
Statistical Process Control method applied to enhance the inspection or
manufacturing system and to control the variables.
Has the supplier identified the need for statistical techniques?
Have procedures been employed to implement & control their use?
Support Questions:
Does the supplier's procedure describe appropriate confidence levels
for process control and product acceptance?
Have critical processes been identified for process capability tracking?
Are statistical control charts being used for monitoring and controlling
production and measurement processes for all types of production and
quality control?
Are all records being documented and maintained resulting from the
application of statistical methods?
Are these records being reviewed regularly for their effectiveness?
Are criteria such as critical customer characteristics and engineering
specifications used to select key process parameters?
When a lack of process capability is determined, is a plan requiring
process improvement developed & implemented?
Is there a plan for continuous improvement and variation reduction?
Are SPC charts being used to determine long-term process capability?
Is measuring and testing equipment specified and used at each process
control point?
Is there evidence of programs to reduce common cause variations?
Do SPC procedures specify enough application and interpretation
details (such as trend or run definitions) to ensure their proper use?
4.20 Subtotal: (Assigned Max Score: 16)
4.21 COST OF QUALITY PROGRAM (Assigned Max Score: 4)
A documented system that identifies, tracks, reports and takes action to
reduce the costs associated with assuring quality
Does the supplier have a documented quality cost system?
Does the supplier use the data collected to develop effective corrective action?
Support Questions:
Does the system categorize the cost data into prevention, appraisal,
internal failure and external failure?
Does the data readily identify scrap, rework and failure costs?
Does the system include sub-tier surveillance costs?
Is the system well understood by those submitting data into it?
Is there objective evidence that the data is being used?
Does the collection of quality costs extend beyond the
Has the data been charted and reviewed for trends?
Is the trend showing improvement resulting from proper corrective
action?
4.21 Subtotal: (Assigned Max Score: 4)
4.22 CUSTOMER ORIENTATION (Assigned Max Score: 13)
Every employee views meeting customer requirements, both internal and
external, as their primary task.
Does the supplier have a customer orientation culture?
Does the organization actively seek ways to keep all employees aware of
customers and their role to meet their needs?
Does the organization know how their customer(s) perceive their products
or services?
Support Questions:
Do all employees understand the internal and external customer
concept?
Is there evidence that all employees are focused on customer
satisfaction?
Does the supplier attempt to measure customer satisfaction?
Does information about customer satisfaction get reported to the
responsible department?
Is there evidence that customer data is used to improve products or
services?
Does the supplier attempt to review the real needs and expectations of
customers?
Does management review customer satisfaction data and trends?
4.22 Subtotal: (Assigned Max Score: 13)
4.23 CONTINUOUS PROCESS IMPROVEMENT (Assigned Max Score: 8)
Understanding that all products and services are the result of a process
and that all processes must be continuously improved by the process
owners.
Does the supplier recognize the concept of process definition?
Are the key production/business processes flow charted?
Do the processes have defined owners?
Is there evidence of process improvement in cost, time or quality?
Do process improvement teams exist?
Does the supplier train all employees in problem solving and other quality
improvement tools?
Support Questions:
Is there a reward or recognition program for process improvement?
Do all employees participate in process improvement?
Does the organization structure support on-going process improvement
teams?
Is defect data used to set priorities for process improvement?
Do all levels of the organization participate in process improvement?
4.23 Subtotal: (Assigned Max Score: 8)
_
4.24 TOTAL QUALITY MANAGEMENT (Assigned Max Score: 10)
An established value system in which both individual and group actions
reflect a quality first attitude and direction to meet world-class
requirements.
Is the organization bound together by a belief that total quality is the key to
success?
Does the supplier have a published commitment to total quality?
Support Questions
Is total quality improvement viewed as a long-term process?
Is there evidence of top management leadership?
Does the organization focus on the customer?
Does the organization encourage employee involvement at all levels?
Is training provided to assure each employee understands and supports
total quality?
Are employees motivated toward achieving continuous improvement
goals?
Does the organization strive for innovation in meeting customer
satisfaction?
Do processes include the necessary technology and tools?
Is all information required to support total quality management clear,
complete and accurate?
Are suppliers treated as valuable partners?
Do the suppliers strategic and business plans address total quality?
Is there evidence that all communications are two-way, clear and
consistent in support of total quality?
Are there established accountability measures that are reported and
analyzed?
Are there established recognition and reward systems?
4.24 Subtotal: (Assigned Max Score: 10)