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 In the manufacturing area, two bottles of shelf life sensitive material were found to be out-of-date by a couple days, and documentation had been altered, “cross outs”, but there was no evidence that the markups were approved.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 year’s 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.