The Role of the Process Audit in ISO 9000 Internal Audits

[Raffy]

Internal Audit Vs. Process Audit

We haven't perform an internal audit for the year and now, I'm trying to consider our process audit in exchange with the planned internal audit. Can we consider process audit as an internal audit since" in internal audit to determine that the QMS conforms to the planned arrangements (7.1),...and is effectively implemented and maintained" and process audit has an almost same meaning conform, effectively implemented and maintained? We perform process audit daily and randomly audit every department according the requirements of the customer and QMS.

Any feedback would be appreciated.
Thanks in advance.
Best regards,
Raffy

 

[Tim Douty]

Internal Audit vs. Process Audit

We have just been ISO 9001:2000 Certified - so I may be going out on a limb here, but a similar question came up about our auditing procedure. If it is stated in your procedure that either is appropriate, then you can state it. However, if your procedure does not address the matter - you may have a nonconformance.
Does that make sense to you?

 

[Craig H.]

HI

The question here is what are you auditing against.

For a process audit, you would be looking at the requirements of a specific process and the process' performance against these requirements.

For an internal ISO 9001 audit, you would be looking at the Quality Management System versus the standard.

They may look similar, but the aim is different. That said, in practice, I would say that many internal ISO audits end up being a hybrid of the 2 types...

Hope this helps

 

[Bill Ryan - 2007]

We just passed our "16949" surveillance audit and one of the "minor" findings was that our internal audits had to include the "Product realization" process (APQP). All we had been doing were "process" and "product" (dock) audits, also (we contract for the "System" audits).

Bill

 

[Claes Gefvenberg]

Craig H. said:

---X---

They may look similar, but the aim is different. That said, in practice, I would say that many internal ISO audits end up being a hybrid of the 2 types...

Hope this helps

I agree. That's usually the case.

/Claes

 

[Dawn]

Is it safe to assume that product audits in TS2 are the same as dock or final inspections - inprocess inspections?

 

[Bill Ryan - 2007]

Dawn asked:
Is it safe to assume that product audits in TS2 are the same as dock or final inspections - inprocess inspections?

Yes (per our registrar anyway)

Bill

 

[Mainer]

Just wanted to add my two cents as this is a current topic of discussion for our team. I have found that senior management's perception of the internal compliance audit is that of a non value add activity. Over the past 8 - 12 months I have shifted our internal audit focus to business objectives and then translate the applicable ISO clause appropriate to the review. What I am beginning to see is a cliff at the end of the year where I will have to specificly target many clauses that did not come up during the year's review. I am still working on this model and hope to strike a more meaningfull balance moving forward.

 

[Raffy]

Hi Tim,
Actually, it doesn't says on our spec and I've been thinking of that for days now and I would like to write a revision on our spec telling that a process audit can be an internal audit since we were audited by customers(this customers audits us on different Quality System, One in QS9000, One is ISO9001:2000 and the last one is based on SAC, which means Semiconductor Assembly Council; wherein this questions derived from different quality system namely, ISO9001:2000, ISO9004, TS16949:2002), Yes, they audit us with regards to process but some of the questions were derived from those quality systems. Our GM said that since we were been audited by different customers which is based on ISO, we could consider it....

Our Audits shows an Affirmative Result, there could be non-compliance, but we ensure that we track those issues to closure.

Hi Craig,
"They may look similar, but the aim is different. That said, in practice, I would say that many internal ISO audits end up being a hybrid of the 2 types... "
I agree with you on here, however, I was caught up again, we haven't have the planned internal audit programme in which the ISO is requiring and I need to make a decision in which how am I gonna document the process that we were been audited by our customers based on different quality system and I'm trying to have it resolve before the next ISO audit which would also happen this month and in my perception, since we didn't come up with an internal audit programme for the year, I would suggest that documenting all customer audit in exchange with the traditional internal audit

Hi Mainer,
"I have found that senior management's perception of the internal compliance audit is that of a non value add activity. "

I agree with this, because it was also the same response I got from our GM, is that "Why do I have to perform an Internal Audit, since our customer audit us against three different quality system? He says that it is redundant to conduct another audit and it hurts when your boss says that its a "Waste of Money" and "Time" Plus the "Effort" . We do make corrective actions for this audit done by our customer.

The question comes out now, "Can we show the audit to the ISO? We track all nonc-ompliance and ensure that all Open Items are closed. And we have documents to show that we did adjustments on our specs. The only problem that I'm dealing with is "How am I gonna include this on my specs? Can I write a provision saying that Customer Audit can be exchanged to Internal Audit as long as the audit they conduct is based on ISO standards? Can we also include that Internal Audit can be done based on business opportunities?

Hi Jim,
Speaking of continual improvement, can our process audit be part of the continual improvement? For example, we didn't conduct an internal audit on an area, for the sake of conversation its on Production Department, we are not going to conduct an internal audit on this area because, we randomly check their activities, systems, etc through out process audit and this audit is also track and follow-up to closure. How am I going to document this? Or as part of continual improvement?

Thanks to everyone.
Best regards,
Raffy

 

[M Greenaway]

Jim

You cannot confirm compliance to ISO9001 from a desktop review of documents, particularly in this day and age of ISO9001:2000 where documentation has been somewhat relegated in significance, hence possibly wont be there.

Even in the days of the 1994 standard where we were told to have procedures the standard not only said to create them, but to implement and maintain them. How could we confirm compliance to implementation and maintenance from a desktop ?

Also internal audits need to cover the system, that is the interrelationship of processes - not just processes themselves.