What is the difference between Process and Compliance Audit?

B

baby12

#1
when my company is having quality management system must i audit process separate from compliance audit
 
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RoxaneB

Super Moderator
Super Moderator
#2
when my company is having quality management system must i audit process separate from compliance audit
I'm not sure I completely understand your question, but I'll give it a try...

In my opinion...

A process audit is a review of a process's inputs, activities, and outputs, verifying conformance to requirements, such as internal standards (e.g., documents) and external standards (e.g., ISO 9001).

A compliance audit is an audit that verifies/validates the organization's systems and process adhere (or comply) to regulatory and legal requirements (e.g., enviromental laws, safety standards, etc.)
 

qusys

Trusted Information Resource
#3
when my company is having quality management system must i audit process separate from compliance audit

I assume you are speaking about ISO 9001 .
8.2.2 clause does not refer to any distinction among internal audit type.

However process audit are referred to the a specific process with its imput, output, support process, resource, procedures and so on, following the turtle diagram approach.
Compliance audit are usually referred to check if the activities are done according to set procedure and/or legal/statutory requirements:bigwave:
 
J

Jason PCSwitches

#4
I'm RCBeyette on this, can you explain why your asking this question and provide an example of what your up against?
 
J

Jaxsters

#5
I agree with RCBennette. Process audits are the style of the FDA audits. They have been performing these type of audits for years. It is the audit process where you review the input and output of a specific system. It is usually good at verifying the controls used by a company to ensure a quality product.

Questions asked are things like how items move though the process (i.e. controls or checks and balanaces). An example of such questions are:How are QC samples managed? Who brings the samples to QC? How are they checked in to QC? Is there a log? Where are they stored and by whom? How are the samples checked out from storage and tested? How are the test results documented and reviewed? How does QC send the information to QA for release of product?

The questions will review the transfer of information and/or goods from one department to another.
 
#6
when my company is having quality management system must i audit process separate from compliance audit
Personally I would audit the QMS as a whole, that would include process with compliance. But it all depends on what your audit procedure tells you to do.
 
A

Al Dyer

#8
All audits are to review whether we are in compliance with our stated goals. Why should there be a difference between process or compliance? Aren't we supposed to be in compliance with our stated processes as a way of daily business? There are too many supposed differences between audit types, first article, in0process, tooling, gaging, finak, dock etc.... we are continually monitoring ourselves based on what we said we were doing.

Al...
 
A

ab001

#9
As others have mentioned, the question is not very clear. I'll try a different answer:

You test for compliance by comparing criteria to results.

You test for adequacy by comparing criteria to systems/processes.

It's the same as Verification/Validation. You have to do both.
Are you doing the right thing?
Are you doing the thing right?


when my company is having quality management system must i audit process separate from compliance audit
 
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