Do Management Review records have to be on a controlled form?

QE1993

Involved In Discussions
#11
Looking at ISO13485, it almost seems like it is up to the organization how they control the medium of their records. 4.2.5 states "the organization shall document procedures to define the controls needed." So, we can have our forms go through the same process as 4.2.4, but it is not required? Am I interpreting this correctly?
 
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QE1993

Involved In Discussions
#12
Yes, that makes sense to me. If there are any actions/decision that we decide to take from management review, we assign them a CAPA or CI, which then has its own set of controls, signatures and approvals, so for us, I don't think its necessary to double up on authorizations. Unless, we want to take this a step further and authorize the opening of the CA in the first place. Ugh. I"m not good at this...I overthink everything lol. :frust:
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Looking at ISO13485, it almost seems like it is up to the organization how they control the medium of their records. 4.2.5 states "the organization shall document procedures to define the controls needed." So, we can have our forms go through the same process as 4.2.4, but it is not required? Am I interpreting this correctly?
If you decide you need a rigid format for some record (a form), and this can happen either because a standard requires it or for any other reason, then the form you establish needs to be controlled. But this is not the case by default, and specifically WRT management review summaries it's not required by 13485.
Chill.

Yes, that makes sense to me. If there are any actions/decision that we decide to take from management review, we assign them a CAPA or CI, which then has its own set of controls, signatures and approvals, so for us, I don't think its necessary to double up on authorizations. Unless, we want to take this a step further and authorize the opening of the CA in the first place. Ugh. I"m not good at this...I overthink everything lol. :frust:
Yes - Unless you want to take this a step further and authorize the opening of the CA in the first place. Or any other action decision, actually, if you ever make such.
Please note that, regardless, you will need at least one dated wet signature (or an equivalent) on the management review summary - to authorise the summary itself. If this is done by someone with appropriate seniority (say, VPQA), this may suffice as assurance that the decisions listed are accurately captured and made by individuals with appropriate jurisdiction etc., and are thus valid (but make sure to state this significance explicitly, somewhere in your management review SOP).
 

jradford

Involved In Discussions
#14
The standard doesn't require that. It does, however, require recording "any decisions and actions", so signature of the appropriate individuals (not necessarily all attendees) may be seen as authorization of such decisions.
I have also just received an NC for not having the attendees sign in. I removed the names for this post. Auditor wrote:
Did not find objective evidence of attendees at Management Review. Management Review minutes were addressed to J.E, Z.E. from J.R. However,
there was no objective evidence that they were present at the Management Review meeting.

I don't know how to write up a corrective action for something which does not have a requirement. I do agree it is a good idea to do a sign in sheet with titles. I have no problem updating the SOP.
 

Jim Wynne

Staff member
Admin
#15
I have also just received an NC for not having the attendees sign in. I removed the names for this post. Auditor wrote:
Did not find objective evidence of attendees at Management Review. Management Review minutes were addressed to J.E, Z.E. from J.R. However,
there was no objective evidence that they were present at the Management Review meeting.

I don't know how to write up a corrective action for something which does not have a requirement. I do agree it is a good idea to do a sign in sheet with titles. I have no problem updating the SOP.
Please give us the entirety of the NC statement, including references to the standard and/or your company's internal requirements upon which the NC is based.
 

jradford

Involved In Discussions
#16
Please give us the entirety of the NC statement, including references to the standard and/or your company's internal requirements upon which the NC is based.
That is the entirety of the NC statement. The reference was to ISO 13485-5.6.1. This was an outside auditor performing our internal audit since we are a small company and it is impossible to show impartiality.
 

Jim Wynne

Staff member
Admin
#17
That is the entirety of the NC statement. The reference was to ISO 13485-5.6.1. This was an outside auditor performing our internal audit since we are a small company and it is impossible to show impartiality.
There is no requirement in the standard to have a meeting for management review. Management review can be accomplished without it. If you have documented internal requirements for a meeting and a sign-in sheet, those should have been referenced in the NC statement. There are signs here that might make you question the competence of the auditor. You should ask the auditor where the violated requirements are documented, and why that source wasn't cited in the NC statement.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#18
There are signs here that might make you question the competence of the auditor. You should ask the auditor where the violated requirements are documented, and why that source wasn't cited in the NC statement.
When an organization decides to outsource it's internal audit process for being small and hard to ensure impartiality and objectivity, they enter into a process of "selecting" a competent internal auditor. In most cases, it ends up being the same person who acted as a "consultant", "assisting" them in becoming ISO whatever compliant and certified. So, if the organization now questions the competence of the (outsourced) internal auditor, they would be in another pickle with external auditor and regulatory agencies.

Nevertheless, I do agree that the NC shows the typical mental paradigm of archaic auditing. If the auditor was concerned about the involvement and awareness of some of the people who should be participating in the management review, s/he could easily speak with them to ascertain what happened. One of the advantages of auditing a small organization is the fact that you normally have access to everyone in a very short time.
 

Jim Wynne

Staff member
Admin
#19
Also, I'm wondering if the auditor spoke to the people who were supposed to be at the meeting and asked them if they were. You might also ask the auditor, with regard to the absence of a sign-in sheet, what would prevent anyone from signing in and immediately leaving.
 

pziemlewicz

Involved In Discussions
#20
Sounds like your auditor is spinning the requirement into something that they want it to be. I would contest the finding. If anything this is an OFI.
 
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