CASE STUDY Internal Audit Program

This week you have been assigned to audit the XYZ Company. This is a full Quality
Management System Audit and in the last day you schedule the audit of the audit
program. The week has been interesting.
Earlier in the week you conducted the audit of the Management Review and found
that they have one Management Review a year. For customer complaints you found
the biggest customer issues on average a corrective action at the rate of one every
other week (27 complaints in the past year). You wrote a major finding against the
Design Group for not conducting, or having any objective evidence of Design
Reviews. In Purchasing a minor was written for not getting the correct level of
approval on one out of a sample 10 purchase orders. In calibration, you wrote a
major on the process for having Out of Tolerance reports that had not been
processed in over a year. In the manufacturing area, two bottles of shelf life
sensitive material were found to be out-of-date by a couple days, and
documentation had been altered, cross outs, but there was no evidence that the
markups were approved.
The Quality Manager, Mr. Best, is in charge of the audit process. You asked about
how he determines if the audit process is effective and he responded with the need
to make sure they complete the Internal Audit schedule on time. You reviewed past
years performance and all audits were performed on time. They also track the
number of nonconformances and there is a goal to reduce the number written by
over 50% which they have achieved this year. In fact, the only nonconformances
written in the year were written by one of the auditors, which are two minors in the
Contracts area.
Mr. Best, referenced AUD101, their audit procedure, and it described the audit
process, the documents used and the training requirements. The training
requirement is a one hour class held with Mr. Best. You ask to review the class
content and it is centered on the audit forms and checklists and recording the
results. The trained auditors are from different disciplines, none of them audit their
own work. You reviewed the schedule and essentially, the plan is to conduct one
audit per year for each process, this was set up years ago and aligns with the older
ISO 9001 series which intended to cover the 20 elements. So, this means they do a
Records audit, a Document Control audit, a Preservation of Product audit once,
annually. Checklists were set up initially around the older standard and have not
been revised.
You conducted a follow-up on the two corrective actions that were written and
possible C/A implementation. You find they were not reported at the annual
management review, just the fact that they had achieved an excellent rating in a
reduction of findings. After further investigation, you found the corrective actions

technically have not been closed, a response was given, it was approved but they
are three months delinquent in implementation. Mr. Best explains corrective
actions are so rarely needed, that when they are, they are sometimes forgotten. He
promises to have these looked at before the conclusion of the audit.

Your mission:
1. Are reviews of Management Review and Design Review established at
adequate intervals?
2. What is your perception of the Internal Audit program?
3. How may does this area affect other processes of the Quality Management
System?
4. What type of nonconformances would you write against this process?
5. In your turtle exercise, provide possible short scenarios on how you would
fix the Internal Audit process.