Internal Audit Plan per Risk Analysis

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sagai

Quite Involved in Discussions
#2
When you refer to "based on Risk Analysis", what kind of Risk Analysis are you referring to?
 

sagai

Quite Involved in Discussions
#4
I think it sounds too slippery to me to involve risk based selection into the audit planning.
However, actually there is no explicit expectation defined in ISO13485/21CFR820 as regard to the yearly frequency.
 
M

mlaurie

#5
We were cited in Mar 2013 ISO 13485 re-cert audit for a minor NC for not have done any Risk Assessment the previous year. Which I missed in my internal audit (no NC there). I did Risk Assessment by various processes for 1) contract review / processing orders, 2) Manufacturing, 3) Purchasing / Procurement of raw material, 4) M&M etc.. I then audited against the a)inputs, b)the assessments and c)the outputs. Ref ISO 14971. The assessments are on-going and I try to audit the previous assessment after I’ve completed the next scheduled one. The audits look appropriate to the plan but not locked in to which Risk Assessment to audit, only that 1 or 2 are scheduled in. I don’t lock myself in with Due Dates for auditing, only “periodic” throughout the year.
 

SGquality

Quite Involved in Discussions
#6
I think it sounds too slippery to me to involve risk based selection into the audit planning.
However, actually there is no explicit expectation defined in ISO13485/21CFR820 as regard to the yearly frequency.
I did ask the same question in Apr 2013 and Sidney had posted a link where another Cover, Patricia has some very good Risk Based auditing. I wanted to know if someone has editable versions of the Risk based auditing documents.


We were cited in Mar 2013 ISO 13485 re-cert audit for a minor NC for not have done any Risk Assessment the previous year. Which I missed in my internal audit (no NC there). I did Risk Assessment by various processes for 1) contract review / processing orders, 2) Manufacturing, 3) Purchasing / Procurement of raw material, 4) M&M etc.. I then audited against the a)inputs, b)the assessments and c)the outputs. Ref ISO 14971. The assessments are on-going and I try to audit the previous assessment after I?ve completed the next scheduled one. The audits look appropriate to the plan but not locked in to which Risk Assessment to audit, only that 1 or 2 are scheduled in. I don?t lock myself in with Due Dates for auditing, only ?periodic? throughout the year.
Thanks for the info mlaurie. Could you pls come back after your assessment is done. Thanks :)
 
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