Process Audit_checklist - SCRIBD

Process Verification Audit - Checklist Audit Area:

Survey Date(s):

Auditor

Supplier Contact(s):

Auditee

Date of Last Process Audit (if any): Process(es) / Product(s) Audited:

Audit Summary and Corrective Action Total Audit Points: Audit Summary:

0

Total Possible Points:

0

Percent:

Corrective Action Required (if any):

NOT SCORED

NCCA #(s):

GENERAL SCORING CRITERIA Rating

Score **

Does Not Apply

NA 1

Does Not Comply

Corrective Action

Requirement is not applicable. Requirement is not met or partially met. There is no evidence of implementation or documentation, or major inconsistencies in implementation or documentation (major non-conformance).

No action required Requires Corrective Action Request (CAR), Document in NCCA

2

Requirement is met but there are minor inconsistencies in Opportunity for Improvement. implementation or documentation, or is in the early phases Recommend CAR, and only preliminary evidence of implementation effectiveness but not required exists.

3

Requirement is met, effectively implemented, and fully documented.

Needs Improvement

Complies

Ability to meet requirement in question:

No action required

** A supplier must have a score of 2 or greater on each of the questions to be acceptable. Score each question using a 1 to 3 point scale, where 3 is the best possible score. Input NA for non-applicable questions.

Process Verification Audit Checklist Area / Station :

PC

IQA

PROD

OQA

SHIPPING

A. Document Control # 1

n

Question

Score

Is the document used are in current Revision Level? Comments:

2

Are procedure / OPL available for operator referance purpose ? Comments:

3

a Do the process control documents adequately address all process parameters and product characteristics?

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Process Verification Audit - Checklist 3

Audit Area:

Survey Date(s):

b Are the Product and Process Key Characteristics known, visible, and is there a documented control plan in place to continuously monitor the process control and capability? c If the part has Key Characteristics, have a Gage R&R and capability study been performed? d Are cleanliness requirements documented on the Control Plan? Comments:

4

Are the Process flow diagrams, PFMEAs, Capability Studies, and Gage R&Rs controlled and up-to-date? Comments:

5

Are other pertinent process control documents up-to-date? (Examples: process sheets, inspection and test instructions, standard operating procedures, preventive maintenance instructions) Comments:

6

Are computer programs used in the manufacturing process secure, controlled and backed up? Comments:

B. Material and Process Control 9

a Is the Control Plan applied at each operation and being followed, from incoming material to shipping? b Is the frequency of inspection being performed as described in the Control Plan? c Are the inspection method and equipment being used as described in the Control Plan? d Do the operator instructions reflect the requirements of the Control Plan? Comments:

10

Do the sample size, frequency and sampling method revised if found Reject ? Comments:

11

Are other pertinent process control documents in place and being followed? (Examples: process sheets, inspection & test instructions, standard operating procedures, preventive maintenance instructions) Comments:

12

Is inspection data retained and stored appropriately? Comments:

13

Are instructions included for packaging to protect the parts (both in-process & final) from damage & contamination, & are they followed? Comments:

14

Are operators properly trained to perform their operations? Are appropriate personnel properly trained for performing work involving key product and process characteristics (especially for special processes)? Comments:

15

Is the WIP well controlled ? Proper Segregation / Identification ? Any harm to the units/ lot ? Comments:

C. Tools/Gages 15

Is there an understanding of which tools/gages are needed for each operation, and are the needed tools/gages at the work station? Comments:

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Process Verification Audit - Checklist Audit Area:

Survey Date(s):

16

Are any tools/gages being used or needed but not called out? Comments:

17

Does the operator understand the proper use of the tools/gages and is he/she using them properly? Comments:

18

Is equipment, including tooling, properly maintained? Comments:

19

Are all the gages calibrated and records retained? Comments:

20

Do Gage R&R studies have acceptable results? Comments:

D. Corrective Action 21

Is the Reaction Plan listed on the Control Plan effective & being followed? Comments:

22

Is there an adequate process for isolation & control of non-conforming material (inc. Customer Notification) & is it being followed? Comments:

23

Is an effective closed-loop corrective action process, including identification of root causes, fully implemented? Does the supplier use NCCA, as appropriate? Comments:

E. Change Control 24

What is the change control process, and is it effective? (All part and process documentation, including Control Plans, must be updated.) Comments:

F. Environmental & ESD Control 25

Is the Temperature and Humidity being controlled ? Record Up to date ? Followed up by respective department ? Comments:

26

Is the ESD Comments:

F. Scoring Summary Total Points 96 Maximum Points Possible Percent of Total Points Available (NA questions are excluded.)

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