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Internal Auditing carried out by a 3rd party - Review of previous audits

W

wayne.wilson7

Involved In Discussions
#1
#1
Hi All,

I have just gone through a customer CI program and one thing they have picked up on is out internal audits that are compiled by a 3rd party.

The internal audit does not reference that the previous audit has been reviewed and previous actions closed.

Does this need to be documented in the new audit that the previous audit has been reviewed or is it sufficient to purely look at the audit plan previous to see if all audits have been closed down.

Regards

Wayne
 
QMS for Medical Device Companies
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Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
#2
wayne.wilson7 said:
Does this need to be documented in the new audit that the previous audit has been reviewed
Click to expand...
I would highly recommend that review of previous audits having been done be documented, but not necessarily the details of previous audits (unless there was a particular issue with previous audit(s)) even if it is in the audit plan. Just my opinion.
 
B

Big Jim

Super Moderator
#3
#3
It would be a good practice to confirm the effectiveness of the closure of previous nonconformances. I always do, both internal audit and CB audit.

Even though the wording "auditors shall not audit their own work" has been removed from the standard, the AS group acts like it isn't so even in their latest clarification. The first clarification misquoted the standard to justify the old position. The newest one got rid of the misquote and still says you can't citing objectiveness and impartiality, ignoring TC-176 guidance on a non AS portion of the standard.

Because of that, it is becoming more common to have someone internally audit the internal audit. No matter the background, it is a good practice.
 
Kronos147

Kronos147

Trusted Information Resource
#4
#4
wayne.wilson7 said:
Does this need to be documented in the new audit that the previous audit has been reviewed or is it sufficient to purely look at the audit plan previous to see if all audits have been closed down.
Click to expand...
IF... your PO said they are to keep the records and be available by phone when you have and audit, AND you have a record of sending them an e-mail the week before saying something like "our audit is Tuesday, be ready," then no.

Otherwise, "Documented information... is available.. where and when it is needed;" (7.5.3).
 
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