Originating and Approving Internal Procedures

P

pearson114

#1
Hi,

Is it acceptable for one person (QM) to originate and approve internal procedures? (against ISO9001/AS9100/AS9120).

Thanks.
 
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Coury Ferguson

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#2
Re: Originating and Approving Procedures

Hi,

Is it acceptable for one person (QM) to originate and approved internal procedures? (against ISO9001/AS9100/AS9120).

Thanks.
Yes, as long as your procedure states who has the authority to write and approve, in my opinion.

But, the best idea is to get the person (owner) responsible for the process be the writer and the QM as the person who approves the procedure. But again, this is my opinion.
 
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#3
Re: Originating and Approving Procedures

Hi,

Is it acceptable for one person (QM) to originate and approve internal procedures? (against ISO9001/AS9100/AS9120).

Thanks.
It depends what you mean by 'acceptable', really! These standards don't prohibit such a thing, but you might want to ask yourself if it's desirable. If you look at the pros and cons, you may find that, with some exceptions, the QM shouldn't produce/approve the vast majority of QMS documentation - unless that person wants to have the burden of responsibility and accountability for everything found needing action in the future...:mg:
 
T

The Specialist

#4
Re: Originating and Approving Procedures

In my opinion you need to have more than one sign-off on any quality document.

Responsibilities should be defined as to who writes procedures on behalf of which department. It should then be agreed whom is responsible for the technical review and quality review of the document.

The process the OP describes undermines the QMS process IMO.
 
#5
Re: Originating and Approving Procedures

In my opinion you need to have more than one sign-off on any quality document.
Any? What about forms, work instructions? It maybe good 'CYA' in the Pharmaceutical Industry, but wouldn't that be 'overkill' for most businesses...?
What are your thoughts to back up such advice?
 
T

The Specialist

#6
Re: Originating and Approving Procedures

Any? What about forms, work instructions? It maybe good 'CYA' in the Pharmaceutical Industry, but wouldn't that be 'overkill' for most businesses...?
What are your thoughts to back up such advice?

Forms and work instructions are filled out by one member and then reviewed/approved by another are they not?
This in itself means that there is a different 'originator' and review/approver.

The purpose of the review and approval process (weather a peer review or quality review) is that any errors are immediately identified and rectified as necessary. Unfortunately, errors are made by even the most experienced professional.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
Re: Originating and Approving Procedures

The bottom line here pearson114 is that ISO9001/AS9100/AS9120 does not specify who has to approve and/or originate the procedures. The Organization determines the authority and responsibilities in your documented procedure, in my opinion.
 
#8
Re: Originating and Approving Procedures

Forms and work instructions are filled out by one member and then reviewed/approved by another are they not?
This in itself means that there is a different 'originator' and review/approver.

The purpose of the review and approval process (weather a peer review or quality review) is that any errors are immediately identified and rectified as necessary. Unfortunately, errors are made by even the most experienced professional.
I don't think that's the case always. I have experienced a number of situations where someone writes something down - let's say a task they don't do very frequently - as a 'work instruction' and it's only they that do this work. Why would anyone else need to review/approve it?

BTW, checking for errors isn't really what this is about - given that you work in a highly regulated industry and that may be the culture - for those outside your industry...and the OP wasn't specifically asking about regulated industry.
 
T

The Specialist

#9
Re: Originating and Approving Procedures

Coury, I agree.

Perhaps I wasn't clear with my response.

You are right that there are no such stipulations. However I (personally) would question the effectiveness of a QM System that allows this to happen (same author/approver)

To the OP: I hear what you are saying about ‘over-kill’ with review and approval sign-offs. It is down to your organisation to determine what documentation requires this level of review. This will be determined by the importance of the document, technical content and probability of error (e.g. check-box forms may be considered out of scope of your review process).

I will stand by my original post though, when I recommend that the documentation example you gave in the OP be written, reviewed and/or approved by more than one member.
This just makes sound QM sense and adds strength to your QMS.
 

qusys

Trusted Information Resource
#10
Re: Originating and Approving Procedures

Hi,

Is it acceptable for one person (QM) to originate and approve internal procedures? (against ISO9001/AS9100/AS9120).

Thanks.
It depends on what you have established in your document control procedure in this sense, including the responbility and the authority to do so.
My opinion is that this process could be in jeopardy and not be effective, because the same person could emit a procedure by himsel/herself and approve, whitout sharing or finding agreement with other potentially impacted/involved process owners.:bigwave:
 
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