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Manufacturing Process Audit Checklist1

This document is a manufacturing process audit checklist that was used to audit a manufacturing process. It includes checks for process parameters, control plans, monitoring records, tooling and equipment. Guidelines are provided to evaluate process effectiveness based on production data, process stability and control parameters. The audit also includes observations made during the audit and a non-conformance report form.

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Sophie ThuyDinh
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0% found this document useful (0 votes)
334 views4 pages

Manufacturing Process Audit Checklist1

This document is a manufacturing process audit checklist that was used to audit a manufacturing process. It includes checks for process parameters, control plans, monitoring records, tooling and equipment. Guidelines are provided to evaluate process effectiveness based on production data, process stability and control parameters. The audit also includes observations made during the audit and a non-conformance report form.

Uploaded by

Sophie ThuyDinh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 4

Report No.

:
MANUFACTURING PROCESS AUDIT
CHECKLIST
Date :

Mfg. Process : Auditee :


Shift : Auditor :

Reference Documents :

Process Flow Chart No. Rev. Date:

PFMEA No. Rev. Date:

Control Plan No. Rev. Date:

Stage Drawing No. Iss. No.

Work instruction No. Rev. No.

S.No. Check points C NC Remarks

1. Is the Manufacturing sequence as per the process


flow?

2. Are the parameters set as per control plan/Work


Instruction?

3. Is necessary parameter values that are to be


recorded updated and verified for any drift?

4. Do process control and monitoring records indicate


that the process were controlled within the specified
process parameter?

5. Is the frequency of process monitoring carried out


as per control plan / work instruction?

6. Are SPC requirements met as specified in control


plan / work instruction? Is the process statistically
stable?

7. Is all MMD tooling, equipment necessary for


process controls are available in good operating
condition?

8. Are special characteristics designated by


appropriate symbols through out the whole
documentation and personnel are aware of it?

Conclusions:

Mfg. Process is : Effective Needs Improvement Not effective

NCR Reference:
Remarks (If any):

Auditor signature Auditee signature


Date: Date:
Legend: C-conformance NC-Non Conformance
Elsmar.com Page 1 of 3
(See Overleaf for guidelines for deciding process effectiveness)
Guidelines for Deciding Process Effectiveness:

Process
Shift Inprocess Final Customer performance index
Data Remarks
production ppm ppm ppm (Cp/Cpk), If
applicable
Month 1

Month 2

Month 3

Month 4

Month 5

Month 6

A. Inprocess, final and customer ppm:

1. Check minimum three months trends of inprocess, final and customer ppm data.
2. If the three months data does not lead any conclusion on effectiveness, look for another three
month previous data.
3. Check if any quality objectives / Customer ppm target is available. If YES go to 3.1 and if NO
go to 3.2.
3.1. Check monthly targets for inhouse, final and customer ppm. If they are not met, look for
analysis, action plan and effective tracking. If these are not satisfactory, process is ineffective
and NCR must be raised.
3.2. If the trend shows a variability that is consistent and predictable, then the process is effective
regardless of the current ppm level. If there is an inconsistent pattern, then the process is
ineffective.
4. A border line case of above can be classified as “Needs Improvements” & NCR must be
raised.
B. Cp & Cpk

1. Check if the control plan specifies the SPC monitoring. If so, check atleast 3 months records
of process stability. If the process is stable, check that capability index (as per control plan) is
maintained or exceeded. If these are not in place the process is ineffective and NCR must be
raised.
2. If the three months data does not lead any conclusion on effectiveness, look for another three
month previous data.
3. A border line case of above can be classified as “Needs Improvements” & NCR must be
raised.
C. Process control Parameters

1. If process control parameters as per control plan are found to be nonconforming the process
is classified as ineffective and non conformance report must be raised.
If Manufacturing process is found to be ineffective / needs improvement, evaluate the following
1. Are customer end ppm’s predictable & acceptable to customer. (i.e judge from
YES NO
complaints/rejections)
2. If no, additional controls to be implemented in short term to ensure that customer is protected till
corrective actions are effective.
Short term action Responsibility Target date

Elsmar.com Page 2 of 3
Report No:

Manufacturing Process Audit Observations


Date :

Part No: Issue No. Machine No.


S.NO. Process Parameter Specified Actual C NC Remarks
1. Cycle time
2. RPM
3 Cams
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
4. Tools
a)
b)
c)
d)
e)
f)
g)
i)
j)
k)
l)

Note: Refer annexure 1 for manufacturing process audit non-conformance report


Elsmar.com Page 3 of 3
ANNEXURE – 1

Report No. :
MANUFACTURING PROCESS AUDIT NON-CONFORMANCE
Date :
REPORT
NCR No. :
Auditor Auditee
Mfg. Process Dept. / Function Shift
Audited
Audit Findings:

Auditor Signature: Auditee Signature:

Cause (s):

Correction, containment (if any) and corrective action: Target date :

Auditee Signature Date:

Follow up audit findings (Verified for implementation and effectiveness)

Auditor Signature Date:

Closed: Yes No Closed on: MR Signature:

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