Can any one help me to solve a sample or example for the following situation? I know it is deal with requirements of 8.2.2 but just give me example how to write down the solution.

“Situation number 6
In the quality manager’s office, the auditor asks to see the schedule for internal audits. This schedule shows that each of the eight QMS processes are audited every six months. The auditor asks the quality manager how the frequency of audits was decided. The manager says that when the system was set up three years ago, 6-month intervals were specified for all processes. The company has kept to this original schedule. The auditor asks to see the file containing corrective action requests (CARs). It lists 85 CARs for the past two rounds of internal audits. Of these, 65 CARs are in the production department and the remainder are spread evenly over five other departments. Two departments received no CARs.”

It has to do with the following requirement from 8.2.2 “An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.”

Alin

This sounds awfully familiar - you wouldn't be taking an IRCA exam sometime soon would you?:notme:

Can any one help me to solve a sample or example for the following situation? I know it is deal with requirements of 8.2.2 but just give me example how to write down the solution.

“Situation number 6
In the quality manager’s office, the auditor asks to see the schedule for internal audits. This schedule shows that each of the eight QMS processes are audited every six months. The auditor asks the quality manager how the frequency of audits was decided. The manager says that when the system was set up three years ago, 6-month intervals were specified for all processes. The company has kept to this original schedule. The auditor asks to see the file containing corrective action requests (CARs). It lists 85 CARs for the past two rounds of internal audits. Of these, 65 CARs are in the production department and the remainder are spread evenly over five other departments. Two departments received no CARs.”

You posted this same question in another thread. Courtesy requires that you do not double-post. All posts receive careful attention by our members and moderators. The duplicate post has been deleted.

Stijloor, Moderator.

This sounds awfully familiar - you wouldn't be taking an IRCA exam sometime soon would you?:notme:
very soon i will be taking exam.

very soon i will be taking exam.

Good luck with the exam. I am interested to know where that particular situation came from, is it part of the course material or perhaps pre-course reading?

Good luck with the exam. I am interested to know where that particular situation came from, is it part of the course material or perhaps pre-course reading?

it is taken from website during my online study.

I've seen that scenario before and I know who wrote it....and I know the answer, but alas, that dog won't hunt;)

It has to do with the following requirement from 8.2.2 “An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.”

Alin That's what I figure. The auditor appears to be getting to the schedule not having been adjusted to address the CARs. However, there is no requirement that the schedule be adjusted to address corrective action requests. For example, if 2 departments aren't getting any CARs there is no *requirement* that the audit frequency be adjusted.

I would be looking to see how they are addressing what *appears* to be the problems in the production department. Whether it would be an increase in audits of production vs. CAR content/resolution would depend upon the subjects of the CARs. I would also be interested in the processes and the company as a whole. Off hand I have no idea whether the amount of CARs in production is justified without being there in the office and knowing what the company makes, its processes and other factors such as CAR content/resolution.

On the other hand, it may simply be that the company rep did not actually explain what criteria they used to set their audit schedule 3 years ago.

This may or may not be an actual question from the exam, but I'm surprised replies are almost all focused on the source of the scenario rather than offering help. If it's from the actual test, the cat appears to be out of the bag big time already.

NOTE: If this is an actual question, the IRCA (or whoever) should contact me to have this thread deleted!!!

That's what I figure. The auditor appears to be getting to the schedule not having been adjusted to address the CARs. However, there is no requirement that the schedule be adjusted to address corrective action requests. For example, if 2 departments aren't getting any CARs there is no *requirement* that the audit frequency be adjusted.

I would be looking to see how they are addressing what *appears* to be the problems in the production department. Whether it would be an increase in audits of production vs. CAR content/resolution would depend upon the subjects of the CARs. I would also be interested in the processes and the company as a whole. Off hand I have no idea whether the amount of CARs in production is justified without being there in the office and knowing what the company makes, its processes and other factors such as CAR content/resolution.

On the other hand, it may simply be that the company rep did not actually explain what criteria they used to set their audit schedule 3 years ago.

This may or may not be an actual question from the exam, but I'm surprised replies are almost all focused on the source of the scenario rather than offering help. If it's from the actual test, the cat appears to be out of the bag big time already.

NOTE: If this is an actual question, the IRCA (or whoever) should contact me to have this thread deleted!!!
During the group discussion I was a loner saying we need to look into 70% of the findings from one dept, to see whether they are repeated or from different. but Since, there was no support, we came to consensus that it is a nc.

The Lead assessor training which I am undergoing has a similar question and our trainers said that this is a NC under 8.2.2.

Now I am confused how am i supposed to answer in the exam..if something similar comes...

will your argument hold..if I write in the exam..

Referring back to the case study, an auditor should have asked for (or done) a review to see what the CARs were for, if there are trends.

One simply can't say, at this point in the audit, if the audit schedule should have been adjusted 'based on status and importance'! BTW - auditing the 6 procedures of and in themselves, without reference to any other process of the QMS is another indication of ineffectiveness in audit planning.

No NC can be issued at this time! There has to be objective evidence that not changing the audit schedule, with or without considering the CAR's, is not working......The auditor should then use their skills to determine where it's not effective!

If the standard answer is 'write an nc' then it's wrong. I believe you're permitted to justify why you wouldn't write an NC if you can give a response which describes something similar to my rationale above.......
i think it said 8 QMS procesess....

//auditing the 6 procedures of and in themselves, without reference to any other process of the QMS is another indication of ineffectiveness in audit planning.//

"Please show how your internal audit has assessed the effectiveness of the interactions between those 8 processes."


"I notice that you conducted an audit on 'Production QMS'. However you have four production lines, making different things. Please show how your rolling audit schedule covered each of those lines in a timely and effective manner."