Quick Skill Quality (Training for Technician) : Process Audit Vs Product Audit

Process Audit Vs Product Audit

Hello friends,

In the previous concept, we understood what is Audit and Types of System Audit. Now we will discuss on product audit and process audit. Before that it is also necessary to be familiar with the audit once again, then we will revise the definition of the audit again in this concept.

Audit:

it is a systematic approach in which independent auditor examine the documented process to evaluate and determine the audit evidence that the process is fulfilled their audit criteria.

Managing the process and product is very important in the manufacturing sector. We need to see that our process is running correctly, and check the product to see if it is making right. This is why we audit both process and product. Now we will understand about product audit and process audit.

Process Audit:

Process audit is an important integral part of quality management system. Process audit is very much important in those companies which is relates to manufacturing. If we talk about automotive industries then in automotive Industries, we use IATF 16949 which is the latest quality management system. IATF 16949 talks about the exclusive requirements on process audit. So using good practice, and you should be done process audit for conducting audits for all the processes either it is manufacturing and other transactional or service processes.

In process audit, we verify whether our process is meeting the given working standard, and all parameters. In this, we verify that our process or the work that we had decided, we would do our work with work instruction or criteria.
If the process parameter is not correct then output will not correct. So basically, we check those parameters in the process audit. Like work instruction, control plan. These are the reference documents which is shows that process parameter is in control or not.

So it is very important to the manufacturing organization to ensure quality of the product being manufactured and dispatch to the customer. Process audit helps to identifying the abnormality in the process so that we can take action on it and making continually improvements.

Definition:

Process audit is an 'examination' to determine the process effectiveness and efficiency using control plan, work instructions, procedures and customer specific required approaches and is aimed at ensuring output is being achieved.

In IATF 16949:2016 of Quality management system, according to its clause 9.2.2.4 manufacturing process audit,

Audit should be made in all manufacturing process over each three years calendar periods.
Using customer specific approaches else determine the approach to be used.
Audit shall be complete with covering all shifts.
Audit of effective implementation of the process, risk analysis (such as PFMEA), control plan, and associated documents.

Product Audit:

In product audit, we examine parts. When examining parts, keep in mind the parameters of our control plan and work instructions. In addition, parts are also tested.

Definition:

Product audit is the examination of a particular product in order to evaluate whether it conforms to the requirement or not. Specifications (length, width, inner diameter, outer diameter etc.) performance and customer requirements.

Action to verify or validate an output of product characteristics "each stage of manufacturing processes" in relation to actual design requirements.

Part thickness verified by Vernier Caliper

In IATF 16949:2016 of Quality management system, according to its clause 9.2.2.4 product audit,

The organization will audit products using specific approaches required by customers at appropriate stages of production and delivery to verify conformity to the requirement set by the customers, where not defined by the customer.

How product & process audit is done in an organization?

There are basic steps or procedure to done a product & process audit :-

First of all, prepare the product & process audit plan.
Make a check sheet using the drawing/std/control plan.
Complete all the steps as per the Process Flow Diagram (PFD).
Conduct the product & process audit as per plan & given criteria in your organization.
If audit not done accordingly, then reschedule the plan by legend & give reason for delay.
Auditor conduct the process audit as per control plan or process audit check sheet. While conducting the audit, auditor check the objective evidences whether the process comply with these requirements.
Product to be audit at all stages from RM to dispatch.
Start audit with verification of last audit observation, customer complaint etc. During process & product audit, it is mandatory that whole day of manufacturing process should be cover in audit.
Auditor summarize the NC's observed during process & product audit.
If any NC raised by auditor, then Auditee will submit the action plan within 3 days and implement the corrective & preventive action within 7 working days from the day of audit conducted.
Now, check the countermeasure implimentation. (If found OK proceed further otherwise raise NC again)
After all, compile & close the audit report.

You will understand this hopefully.
Thank you.

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