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PA-audit checklist

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GPQ-MAN-07Product AssuranceAudit ChecklistGPQ-MAN-07 MSM-GP/27 APR 2001ItemAudit Element C PC NC N/A RemarksNo.I. General Product Assurance1. Organisation and Staff1.1 Does the contractor have a formally established PAorganisation with the elements of Safety, Reliability,Maintainability, S/W PA, Quality Parts, Materials andProcesses, Configuration Management?1.2 Are the Product Assurance functions independent ofManufacturing, Engineering and other organisation?1.3 Are there formulated objectives of the organisation?1.4 Is management emphasis on “prevention” rather thandetection of quality problems?1.5 Are the responsibilities of supervisors and managers,etc. formally defined?1.6 Does the person responsible for Product Assurance ona project have access to higher management for thefocussing on and resolution of problems?1.7 Are the PA functions staffed to the proper complement?1.8 Does the Product Assurance organisation havesufficient facilities, equipment and tools for appropriateevaluation of materials and hardware quality?2. Procedures2.1 Does the contractor have a Product Assurance Manualor a set of procedures covering Product Assurance?2.2 Do procedures identify “who” does “what”, “when”,“how” and “where”?2.3 Are PA functions and responsibilities performed ...
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GPQ-MAN-07
Product Assurance
Audit Checklist
GPQ-MAN-07 MSM-GP/27 APR 2001Item
Audit Element C PC NC N/A Remarks
No.
I. General Product Assurance
1. Organisation and Staff
1.1 Does the contractor have a formally established PA
organisation with the elements of Safety, Reliability,
Maintainability, S/W PA, Quality Parts, Materials and
Processes, Configuration Management?
1.2 Are the Product Assurance functions independent of
Manufacturing, Engineering and other organisation?
1.3 Are there formulated objectives of the organisation?
1.4 Is management emphasis on “prevention” rather than
detection of quality problems?
1.5 Are the responsibilities of supervisors and managers,
etc. formally defined?
1.6 Does the person responsible for Product Assurance on
a project have access to higher management for the
focussing on and resolution of problems?
1.7 Are the PA functions staffed to the proper complement?
1.8 Does the Product Assurance organisation have
sufficient facilities, equipment and tools for appropriate
evaluation of materials and hardware quality?
2. Procedures
2.1 Does the contractor have a Product Assurance Manual
or a set of procedures covering Product Assurance?
2.2 Do procedures identify “who” does “what”, “when”,
“how” and “where”?
2.3 Are PA functions and responsibilities performed by
other groups identified?
2.4 Do procedures identify information flow, forms and
instructions for completing the forms?
2.5 Do procedures contain management approval
signatures, dates of issue and revisions and change
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designators?
2.6 Is the distribution controlled and obsolete procedures
removed from use?
2.7 Are procedures available at the appropriate
workstations?
2.8 Are procedures kept updated?
2.9 Do detailed procedures exist for the performance of
inspections and tests?
3. QA audits
3.1 Are systematic internal and external audits performed?
3.2 Are audits performed?
a) According to an established plan?
b) Using checklists?
3.3 Are internal audits conducted on an impartial basis by
qualified personnel?
4. Receiving Inspection
4.1 Is the contractor's receiving inspection flow and
activities documented?
4.2 Are facilities clean, proper lighting exist, and storage
and handling practices followed?
4.3 Are all incoming supplies inspected and tested prior to
use against the requirements of procurement
documents? (appropriate drawings, specifications and
technical instructions)
4.4 Are receiving inspections performed in accordance with
established procedures and instructions?
4.5 Is the following verified?
a) Identification / configuration?
b) Supplier’s documentation?
4.6 When supplies are accepted on the basis of certification
or test report:
a) Are test reports checked 100% against procurement
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documents requirements?
b) Are reports and certification retained?
4.7 When supplies are accepted on the basis of certification
or test report, are checks performed to confirm
conformance?
4.8 Do receiving inspection records indicate date of receipt,
inspections, tests, documents utilised, number
accepted/rejected?
4.9 Is traceability maintained between materials and
certificates, reports and receiving inspection
documents?
4.10 Are there separated storage areas for materials waiting
receiving inspection and materials already inspected
and accepted?
5. Packaging and Handling
Packaging
5.1 Are parts, assemblies and materials verified for
cleanliness before packaging and properly packaged?
5.2 Are parts having critical or highly finished surfaces
protected against damage?
5.3 Are leads of electrical parts protected from
contamination which will effect solderability?
5.4 Are packaging operations covered by written
procedures / instructions, which include at least the
following:
a) Selection of packaging materials?
b) Inner protection?
c) Mechanical protection?
d) Cleanliness and contamination control?
5.5 Are packaging operations inspected and are items
controlled before shipping for proper packaging,
marking and accompanying documentation?
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Handling
5.6 Do handling procedures and instructions exist?
5.7 Are items leaving a controlled area or being transported
between work/test areas carried in appropriate
containers or fixtures to provide adequate protection
from damage or contamination?
5.8 Do the operators have the proper tools to support the
assembly while performing work/test on it?
6. Cleanliness and Contamination Control
6.1 Are there procedures available systematically covering
cleanliness and contamination control aspects?
6.2 Are there specific instructions for:
a) Entering and leaving clean rooms (personnel and
equipment)?
b) Cleaning of clean rooms, including:
1. Cleaning materials?
2. Cleaning methods?
c) Cleaning of equipment to be entered in the clean
rooms?
d) Clean rooms’ maintenance?
e) Control of clean room parameters?
f) Actions in case of alarm including:
1. Stop work?
2. Shield critical items?
6.3 Are items tested and inspected for cleanliness such as
(visual examinations, wipe tests, check for alkaline and
acids) and are the appropriate methods used?
6.4 Are access control instructions posted, visitors sign in
log properly dated and enforced as appropriate?
6.5 Are smock retention areas provided?
6.6 Are clean smocks available?
6.7 Are floor mats placed at all entrances?
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6.8 Are floor coatings peeling or generating dust particles
avoided?
6.9 Is the shedding of sponge, mop of cloth material
evident?
6.10 Are smocks buttoned and worn by all personnel
including visitors?
6.11 Is there food, beverages or smoking?
6.12 Are personal belongings out of sight and stored
properly?
6.13 Is the use of wooden containers with untreated interior
and exterior surfaces or cardboard boxes minimised?
6.14 Are periodic particle counts performed to verify if
within required limits?
6.15 Are gloves, caps, booties and masks appropriate to the
area and worn by all personnel?
6.16 Is the integrity of the environment and contamination
control maintained in relation to the surrounding areas
or to material and mobile equipment entering the area?
6.17 Are other requirements such as: laminar airflow,
vacuum shoe cleaners, air bath entrances, special
waste disposals, etc. enforced?
6.18 Are clean room environment conditions, temperature,
humidity, pressure controlled and recorded?
6.19 Is temperature maintained nominally at 20ºC+/-2ºC or
meet a specific product specification?
6.20 Are positive pressure differentials maintained between
clean room and surrounding area at 6mm Hg and
between clean room and entrance lock at 2mm Hg with
pressure monitors?
6.21 Is humidity maintained, preferably at 30-50% or as
specified in a product specification and monitored with
a hygrometer periodically calibrated?
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7. Manufacturing and Testing
Manufacturing and Testing
7.1 Are manufacturing operations and inspections planned
and described in manufacturing documents? (Shop
travellers, work orders)?
7.2 Do shop travellers include:
a) Revision status / date, release date?
b) Item identification and configuration?
c) Materials / parts to be used?
7.3 Are shop travellers identified / traceable to the contract
no. / purchase order?
7.4 Are support documents to be used referenced? (e.g.
drawings, work instructions)?
7.5 Are rework / repair plans used to document rework /
repair manufacturing / inspections operations? Are
they adequate? Are they archived?
Manufacturing Control
7.6 Is shop traveller kept with product during
manufacturing / inspection operations?
7.7 Are inspection, fabrication and assembly operations
traceable to the individual performing the operation?
7.8 Are all articles inspected to applicable / controlled
documents and are the documents available at the
inspector’s workstation?
7.9 Are unauthorised, marked-up, illegible or defaced
drawings or work instructions being used?
7.10 Is the sequence of operations being followed as defined
in the planning?
7.11 Are accepted and rejected items properly identified and
tagged?
7.12 Are part lists complete for assembly work?
7.13 Are adequate inspection records generated and
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maintained and do they indicate the status of articles
and inspections performed?
7.14 Are assembly operations performed in sequence with
inspection operations?
7.15 Are torquing operations satisfactory? Calibrated tools?
Test Documents
7.16 Does the contractor have standardised procedures and
methods for the preparation, format, content, review
and control of test procedures?
7.17 Are text procedures formally released and controlled
with change and revision pages?
7.18 Do procedures include as applicable the following:
a) Nomenclature and identification of the test article?
b) Characteristics and design criteria to be inspected
or tested, including values and tolerances for
acceptance and rejection?
c) Detailed steps and operations to be taken in
sequence including verifications to be made before
proceeding?
d) Cross-reference of characteristics with measuring
and/or NDT equipment to be used, specifying range
and type?
e) Details or instructions for operation of special data
recording equipment of other automated test
equipment?
f) Layout and interconnection of test equipment and
articles?
g) Identification of hazardous situations or operations?
h) Precaution to comply with established safety
requirements, to ensure safety of personnel and to
prevent damage or degradation of articles and
measuring equipment?
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i) Environments and other conditions to be
maintained?
j) Constraints?
k) Instructions for reporting non-conformance,
anomalous occurrences or results?
7.19 Are test procedures formally approved by PA?
Test Control
7.20 Are provisions made to protect personnel and items
from physical damage and environmental hazards?
7.21 Is the test item inspected to determine evidence of
damage or loose parts?
7.22 Are discrepancies or anomalies resolved prior to
testing?
7.23 Are the following activities performed by PA as
applicable:
a) Witness each test and verify test performances?
b) Observation? Perform surveillance or monitor
periodically the test being performed as directed by
explicit instructions?
c) Data review? Review the procedure and recorded
data at the conclusion of the test cycle verifying
requirements and data entries are compatible?
7.24 Do all documents bear necessary approval signatures
inspection stamps?
7.25 Is rework, repair or modification occurring to the
testing properly documented?
7.26 Are test discrepancies, failures and non-conformance’s
reported, analysed and corrective action implemented?
8. Measurements and Test Equipment
8.1 Does the contractor have up-to-date written procedures
defining his calibration system encompassing
measuring and test equipment, standards, calibration
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and maintenance prescribed intervals and metrology
laboratory environmental controls
8.2 Does the calibration system include all equipment used
to verify the quality of the processes and products
being manufactured?
8.3 Do calibration procedures exist for each equipment
type and include:
a) Equipment characteristics and identification?
b) Location?
c) Frequency of periodic checks?
d) Acceptance criteria?
8.4 Is all measurement and test equipment subjected to a
visual, dimensional and operational inspection upon
receipt and at periodic intervals thereafter?
8.5 Are calibration labels used and do they include at least
the following:
a) Identifier?
b) Due date for re-calibration?
c) Control stamp?
8.6 Is the necessity for and/or frequency of periodic
inspections based on objective evidence of the stability
and continued accuracy of the equipment? Is there
any interval exceeding 1 year of validity?
8.7 Is all measurement and test equipment checked
against a standard of greater accuracy?
8.8 Are temperature, humidity, vibration and cleanliness
controlled to the extent necessary to assure calibration
and continued product measurements of the required
accuracy?
8.9 Is it ensured that errors of measuring and test
equipment do not exceed 10% of the highest tolerance
of any items to be checked with that equipment?
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