What is the Difference between Manufacturing Process Audit and Product Audit?

Jan 17, 2021

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The difference of opinion leads to inquiry and inquiry to the truth: Thomas Jefferson

Introduction

The strength of any country lies in its diversity. People always have a different opinion about the same situation as for COVID-19Business continuity of Supply Chain post-COVID 19, people are using a different methodology to tackle it. Some believe that only the vaccine can protect them while many still think that homemade remedies can protect them against corona.

Objective

The purpose of any kind of audit is to verify the fulfilment of the intended requirement. The manufacturing process audit and Product audit also serve the same purpose although both have specific intent to achieve. The manufacturing process audit is to validate the effectiveness of process input while the product audit is to validate the output of the process in the form of the product.

Definitions: ISO 9000: 2015

Audit (Cl 3.13.1): Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Validation (Cl 3.8.13): Confirmation through the provision of objective evidence that the requirements for a specified intended use or application have been fulfilled

Detailed Information

What is Product Audit (IATF Clause 9.2.2.4)?

An examination of a particular product (at appropriate stages of the production and delivery) to evaluate whether it conforms to intended requirements (as per control plan).

Some of the key objectives are

are all dimensions/specifications correct?

If customer requirements are being followed?
is it in the proper box/container and properly labelled?
is all paperwork completed properly?

It helps to improve quality, increase profitability, enhance customer satisfaction and loyalty.

What is Manufacturing Process Audit (IATF Clause 9.2.2.3)?

An audit of a manufacturing process is a comprehensive examination of the process to verify that it is performing as intended. Manufacturing process audits should ensure that procedures are properly followed and there is consistency in the process.

The manufacturing process should be audited based on the importance and risk to the overall operation. The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan and associated documents.

The similarity between Process and Product Audit:

Both checks intended requirements
Both are periodically planned
Both may be done as per customer-defined frequency and guidelines
Both are done by a competent person
What is going well and what is not

The key difference between the Manufacturing Process and Product Audit:

S.No.	Manufacturing Process Audit	Product Audit
1	Validation of the input in the manufacturing process like 5M (Man, Machine, Material, Method, Measurement)	Validation of the output (Product)
2	We pick up Control plan and check whether process-related characteristics are monitored as per the requirement of the control plan or not	We pick up Control plan and check whether product-related characteristics are monitored as per the requirement of the control plan or not
3	All Manufacturing processes to be audited over each three-year calendar period	No frequency defined (As per VW CSR: once in 12 months for the product manufactured)
4	All shifts where it occurs including the appropriate sampling of the shift handover	Not required (as per GM CSR- on each shift)
5	Verify effective implementation of the process risk analysis (such as PFMEA)	Verify effective implementation of the product risk analysis (such as DFMEA)
6	For all manufacturing processes	At appropriate stages of production and delivery
7	Technical understanding of the relevant manufacturing processes to be audited	Competence in understanding product requirements and use of relevant measuring and test equipment
8	As per CSR, to verify effectiveness assessment of CQI like CQI 9 (heat treatment), CQI 11 (Plating) etc., GM CSR– Layered audit, VW CSR: Certified VDA 6.3 auditor	As per VW CSR: Certified VDA 6.5 auditor

Present Challenges:

How often qualified Internal Auditors are clear about the difference between Process and Product Audit?
How often Customer to the organization is clear about the difference between Process and Product Audit?
How often the Process and the product audit report is different from routine process/product inspection report?

References:

IATF 16949: 2016

ISO 9000: 2015

SI (Sanctioned Interpretations) IATF 16949

This is the 92^nd article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.

Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.

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