Manufacturing Process Audit Checklist

Use the Manufacturing Process Audit Checklist to evaluate and optimize manufacturing processes, ensuring adherence to quality and efficiency standards.

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Manufacturing Process Audit Checklist

CP & CPK

1. Does the control plan specify SPC monitoring? If yes, have at least three months’ records of process stability been checked? If the process is stable, is the capability index (as per the control plan) maintained or exceeded? If these are not in place, is an NCR raised?

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Process Control Parameters

Evaluation Of Manufacturing Process Effectiveness/Improvement

Manufacturing Process

In-process, Final, And Customer PPM

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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Manufacturing Process Audit Checklist

Use the Manufacturing Process Audit Checklist to evaluate and optimize manufacturing processes, ensuring adherence to quality and efficiency standards.

1. Does the control plan specify SPC monitoring? If yes, have at least three months’ records of process stability been checked? If the process is stable, is the capability index (as per the control plan) maintained or exceeded? If these are not in place, is an NCR raised?

2. If the three months data does not lead to any conclusion on effectiveness, is another three-month previous data examined?

3. In a borderline case of the above, can it be classified as "Needs Improvements," and is an NCR raised?

1. If process control parameters as per the control plan are found to be nonconforming, is the process classified as ineffective, and is a nonconformance report raised?

1. Are customer-end PPMs predictable and acceptable to the customer? (i.e., judged from complaints/rejections)

2. If no, are additional controls implemented in the short term to ensure that the customer is protected until corrective actions are effective?

1. Is the manufacturing sequence as per the process flow?

2. Are the parameters set as per the control plan/work instructions?

3. Are 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 was controlled within the specified process parameter?

5. Is the frequency of process monitoring carried out as per the control plan/work instruction?

6. Are SPC requirements met as specified in the control plan/work instruction? Is the process statistically stable?

7. Is all MMD tooling, and equipment necessary for process controls available in good operating condition?

8. Are special characteristics designated by appropriate symbols throughout the whole documentation and personnel are aware of them?

1. Have three months’ trends of in-process, final, and customer ppm data been checked?

2. If the three months data does not lead to any conclusion on effectiveness, is another three-month previous data examined?

3. Is there any quality objective or customer ppm target available?

4. If yes, have monthly targets for in-house, final, and customer ppm been checked? - If they are not met, is there an analysis, action plan, and effective tracking in place? - If these are not satisfactory, is an NCR raised?

5. If the trend shows a consistent and predictable variability, is the process considered effective regardless of the current ppm level? If there is an inconsistent pattern, is the process considered ineffective?

6. In a borderline case of the above, can it be classified as "Needs Improvements," and is an NCR raised?