L
Lismarie - 2009
I'm wondering if anyone have used a scoring system for internal audits based on ISO 13485, taking into account the severity of the non-conformances (i.e. critical, major, minor)
Thanks!!
Thanks!!
T
Tom W
I came up with a scoring process for our internal audits to be able to measure improvements. But it really has not materialized the way I hoped and it will take a long period of time to collect the data. But it might be a start.
Welcome to The Cove! 
Here is a thread Alternative Internal Audit Methods about alternative auditing methods and philosophy.
I have a paper on risk based auditing in this thread Some Options for Risk Based Auditing. There is a spreadsheet in there too.
I hope this helps!
Here is a thread Alternative Internal Audit Methods about alternative auditing methods and philosophy.
I have a paper on risk based auditing in this thread Some Options for Risk Based Auditing. There is a spreadsheet in there too.
I hope this helps!
Welcome to The Cove Forums!
Scoring based on non-conformances?
That looks like a punitive approach to me.
People will be fearful of audits (in this day and age?) :mg:
Here is an idea...
How about scoring and emphasizing the stuff that was done well?
And look for ways to improve the process.
Could that add value?
Just a thought..
Stijloor.
B
Bob Bonville
I am not familier with ISO 13485 so I cannot speak to that specific set of requirements. I can however share with you a technique I successfully used in the past for reporting audit results and subsequent improvement or deterioration of the QMS.
The basic concept involves the metric of average Deficiencies/Audit. There are a number of factors to consider when utilizing this approach such as system maturity, experience and capability of audit staff, quality of audit checklists, and the severity level of the findings themselves.
If you are interested in knowing more, contact me via email and I can share more detail with you.
Bob
The basic concept involves the metric of average Deficiencies/Audit. There are a number of factors to consider when utilizing this approach such as system maturity, experience and capability of audit staff, quality of audit checklists, and the severity level of the findings themselves.
If you are interested in knowing more, contact me via email and I can share more detail with you.
Bob
Bob,
Any chance you can share it here in the Forum?
(I understand that there is material you can and also can not share.
I am a consultant too....)
Stijloor.
Randy
Super Moderator
FollowsWell Andy ya gotta have the hammer to drive the nail don't ya
We know that any well thought out audit program is meant to just be another instrument of terror and torment. I mean, who really cares that a management system is non-scientific and audits and their outcome can't really be quantified? Shucks, let's just go back to the old Yes-No-N/A checklist and keep it simple for the simple.
I'm not saying that I like the idea of grading audits, but you may find some insight from AS9101C. It is a way of assessing a company (aerospace) that is performed as part of an audit. It provides a scoring. It also includes a checklist. I understand that it going to be greatly altered in the near future. I'm sure that Sidney can better speak to this.
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