iso audit questionarie

8/11/2019 ISO Audit Questionarie

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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


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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 throughproduction, 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.


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_______________________________________________________

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 informationon 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


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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 discussadministrative, 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 involvedduring 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 Responsibility8 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


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Does the quality policy support measurements related to company goals

and customer needs?

Support Quest ions:

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 Quest ions:

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 Quest ions:

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 otherdepartments?

4.1.2.2 Resources

Does supplier management allocate adequate resources and personnel

for achieving its goals and objectives during production and verification?

Support Quest ions:

Are standards and arrangements in place for production and

verification?

Are individual(s) skilled and well trained to perform production andverification?

Is sufficient time allowed to do the work?

Is necessary equipment available for production and testing?

Are documented procedures prepared and up-to-date?


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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 Quest ions:

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?


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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 Quest ions: 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 ofthe 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?



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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 Quest ions:

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 Quest ions:

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?


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Support Quest ions:

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)?


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Does the design output document identify crucial characteristics (those

that significantly affect safety or proper functioning of the product)?

Support Quest ion:

Does the design output exhibit how the purchasing, production,

installation, inspection and testing incorporate the design inputrequirements?

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 Quest ions:

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 Quest ions

Does design validation follow successful design verification?

Have product "users" been defined?

Is this definition complete?

Have user needs been established?


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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 designoutput to all concerned, to record any design changes, and to document

that only authorized design changes have been made?

Support Quest ions:

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?


4.5 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 Quest ions:

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 Quest ions:

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


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Has the supplier established a continuing mechanism for controlling

changes in documentation?

Support Quest ions:

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?


4.6. 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 Quest ions:

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?


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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 Quest ions: 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?


4.7 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 Quest ions:

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?


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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 andeffectiveness of the purchaser supplied product?

Does the process assure that all customer supplied material and parts

are identified?


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 theproduct and its traceability?

Support Quest ions:

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?


4.9 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?


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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 Quest ions:

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 thesespecial processes which directly effect the quality?

Support Quest ions:

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?


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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 detectprocess 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 Quest ions:

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?


4.11 CONTROL OF INSPECTION, MEASURING ANDTEST 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?


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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 Quest ions:

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?


4.12 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 Quest ions:

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?


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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?


4.15 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?


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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 PackagingDoes 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?


4.16 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 Quest ions:

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?


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Do procedures state who has access to records and how they gain that

access?


4.17 INTERNAL QUALITY AUDITS (Assigned Max Score: 8)

A documented system to perform internal quality audits to assess how theestablished quality system is functioning.

Has a documented procedure been established and maintained which

outlines the planned and systematic approach for internal quality audits?

Support Quest ions:

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.


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Have procedures been established and maintained for identifying the

needs for all personnel performing activities affecting quality?

Support Quest ions:

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?


4.19 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?


4.20 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?


28/31


29/31


30/31

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 Quest ions:

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?


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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 Quest ions

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?


31/31

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?


iso audit questionarie

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