Energise or Envigorate Internal Audits??

S

seank

#1
Hi All,

Setting the scene;
I work for a Medical Device Manufacturer. We are a head office facility, that holds the CE Mark for approximately 6 different product family's, with all the manufacturing, packaging and logistics sub-contracted out to 3rd parties.

I am the Lead Auditor for the company, and well as the managing the audit program. We are a small company of approximately 25 office staff.

The company operates a mature and complaint ISO 13485 QMS.

My question is this;

This year, during the Internal Audits, I noticed that I didn't feel that the Internal Audit process was adding any benefit to some of the more mature processes that we have. As an example, i'll use the recently audited purchasing process.

The system is well established, using approved suppliers (that don't change), and an ERP system that is globally recognised. The system very rarely goes out of control. While I was auditing this system, it was clear that we were going over old ground and it was more of a 'compliance' exercise as opposed to adding valve to the process.

I have done a risk based audit, and a process approach audit to many of these mature processes, but again, its fairly well established. Any further improvement to the process will require longer term improvement plans, such as six sigma studies, which fall outside of the Internal Audit process.

Does anybody have any suggestions on how to energise or envigorate these audits so that they don't become repetertive exercises?

Thanks to you all :D:D
 
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R

rclanzillotto

#3
Quality Managers are like Offensive Lineman. You don't hear much about them unless something goes wrong :). That said perhaps bring in a third party to conduct the audit. A fresh pair of eyes might provide a different perspective
 

Randy

Super Moderator
#4
Try a new concept...base your audit program and planning on the importance of everything related to the achievement of product conformity & customer satisfaction and the results of previous audits.

I'm also trying to figure out how 6 sigma falls outside of internal audit....if it is used as an improvement activity then audit the sucker. 6 sigma has to have all the planning, resources and objectives as anything else within the QMS.
 
#6
Quality Managers are like Offensive Lineman. You don't hear much about them unless something goes wrong :). That said perhaps bring in a third party to conduct the audit. A fresh pair of eyes might provide a different perspective
That's part of the problem, they shouldn't be playing as an offensive lineman!

As a minimum, the audit manager should be more like a QB, seeing how the play needs to change to accommodate the current circumstances or, ideally, more like the offensive co-ordinator!
 

Jim Wynne

Staff member
Admin
#7
I'm also trying to figure out how 6 sigma falls outside of internal audit....
I think he meant that the internal audit process schedule isn't adding value in certain areas and that those are areas where a comprehensive improvement effort (an SS project) would be more appropriate.
 
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