Control of Documents Responsibilities

[AndyN]

She asked me what if the company got restructured and quality manager got promoted and became something else? ha

Aha! At least she's thinking of the right type of things! Some folks don't like this type of thing because 'it can be audited'...DOH!

Maybe the supervisor doesn't fully understand that it's a position, not a person. If the incumbent QA mgr was promoted, surely you'd find another? You may wish to discuss how the use of Management Review etc can help to plan changes including to the documentation/responsibilities etc.

 

[ScottK]

Often when you implement a QMS you are seen as the Connecticut Yankee disproving Merlin's magic.... People don't want to share what they actually do becuase it makes them feel like anyone can then replace them.

I suspect your supervisor needs some understanding that the purpose of a QMS is to reduce variation in your processes, and in order to reduce that variation things like responsibilities need to be defined.
If you don't define who is responsible for what - from approving documents, to owning a process, to who actually must follow a work instruction - you are defeating the purpose of the QMS.

If I was a customer auditing your document control system one of the first things I'd ask is "who is responsible for approving documents?".. and then I'd look for the qualifications of that person.

All this being said - you can be flexible... like in one system I built we said that part of a manager's responsibility is understanding the jobs of his staff... therefore if a member of his staff was out, the manager could approve a document in his place.
(that's a paraphrase, it was better written in the document control procedure)

 

[qusys]

She asked me what if the company got restructured and quality manager got promoted and became something else? ha

In addition to what ScottK and AndyN said, I would suggest to create awareness about ISO 9001 across all over organization, before embarking in certification.
Top mgmt shall sponsor the project understanding first the implication and the requirements of the standard with the goal to create an advantage to better respond to customers' need as well as improving the organization's processes.

 

[Jen Kirley]

It's nice to avoid complexity where possible and I do agree with identifying positions vs. people.

However, it's really important that the right people approve process changes, and the process needs to somehow identify who they are so proper controls can be reliably established. Your people need to be taught that if they don't already know.

These "Approval loops" should be defined by asking "Who needs to know about changes to this document?" Where I work anyone can make a change to a document, so the approval loop also includes the document's owner, giving veto powers over the change.

How these "approval loops" are communicated is your choice. Some organizations put them in the documents themselves, while others develop a matrix of various approval loops, and associate them by name or number to documents they are assigned to; this name/number is identified in each document, so people who make changes can make sure the right people get informed/the right to accept or reject the change.

I hope this helps!

 

[bill1025]

An advice of mine is to involve process owners and interested parties in developing the process and designing the flow according to the choosen model. Don't make it by yourself but try to work in multidisciplinary, otherwise there could be the risk that the others do not feel it yours.
However, the documented procedure for document control remains mandatory.
appreciated your thanks

This is actually what I think of doing. However, I'm actually a student doing a consultancy placement in that company and my supervisor is actually my project supervisor at uni. Sorry I should have said that earlier. The quality manager in the company does not always have time to see me and discuss with me. And I can't just be sitting here and waiting until he has the time to see me. Therefore I have to work on my own first.

 

[bill1025]

Often when you implement a QMS you are seen as the Connecticut Yankee disproving Merlin's magic.... People don't want to share what they actually do becuase it makes them feel like anyone can then replace them.

I suspect your supervisor needs some understanding that the purpose of a QMS is to reduce variation in your processes, and in order to reduce that variation things like responsibilities need to be defined.
If you don't define who is responsible for what - from approving documents, to owning a process, to who actually must follow a work instruction - you are defeating the purpose of the QMS.

If I was a customer auditing your document control system one of the first things I'd ask is "who is responsible for approving documents?".. and then I'd look for the qualifications of that person.

All this being said - you can be flexible... like in one system I built we said that part of a manager's responsibility is understanding the jobs of his staff... therefore if a member of his staff was out, the manager could approve a document in his place.
(that's a paraphrase, it was better written in the document control procedure)

Thanks for your advice, I apprieciate it.

 

[bill1025]

Thanks guys! I appreciate all your help!!!!!!!!

 

[AndyN]

I would suggest to create awareness about ISO 9001 across all over organization, before embarking in certification.
Top mgmt shall sponsor the project understanding first the implication and the requirements of the standard with the goal to create an advantage to better respond to customers' need as well as improving the organization's processes.

Qusys -- awareness of ISO doesn't really accomplish much, IMHO! For most people it's meaningless, mumbo-jumbo. What they need is competencies in the system, like doc controls, not the ins and outs of the standard. Awareness of the engagement in the overall use and certification etc. is OK, but the details of the ISO standard, I'd avoid like the plague...

 

[qusys]

Qusys -- awareness of ISO doesn't really accomplish much, IMHO! For most people it's meaningless, mumbo-jumbo. What they need is competencies in the system, like doc controls, not the ins and outs of the standard. Awareness of the engagement in the overall use and certification etc. is OK, but the details of the ISO standard, I'd avoid like the plague...

Ok, it was only a "think about".
But according to what billi1025 said that he is currently working as universitary student to help the organization under a university spv , the thing falls down. In any case, I had the feeling that the organization needed some knowledge about the interpretation of how to meet the clauses of ISO 9001, based upon what bill said in his previous prost, about the responsibilities for documentation control.
I think that to have the process owner identified as well as as roles and responsibilities well set are one of the pillars to assure the effectiveness and efficiency of a process

 

[Jim Wynne]

Thanks guys! I appreciate all your help!!!!!!!!

Before you run off, there's one thing you need to be aware of, and that's authority. Assignment of responsibility doesn't necessarily imply a comcomitant level of authority. Don't assign responsibility to anyone unless you also have the authority to delegate authority.

In nearly every company there's ultimately one person who can't be overruled, and it's from that source that all delegation of authority must originate. If authority isn't traceable to the top, it's not authority, and responsibility shouldn't be assigned.