Which documents should be controlled in QMS?

I oversee the quality management system for a large packaging manufacturing company with several sites throughout the US.

We have gotten into a bad habit of putting anything and everything into the QMS.  We feel the need to have document and revision control on everything.  I am trying to help break this habit by defining what is and is not necessary to put in QMS.

For example, we have several training presentations that may be related to several TOP/SOP's.  Is a training presentation something that requires document control?  Is there a better system than QMS to ensure the correct version of the presentation is used and accessible?

(This is my first post so be nice :helpplease: )

Thanks!!

I suppose I should mention that we are ISO 22000 certified in multiple sites, newly FSSC 22000 certified in a few sites, and have no ISO 9000 certified sites (but were previously).

ARGH!!! WE WILL DESTROY YOU!!!  :roflmao:  J/k

In food manufacturing we typically try to keep document control only to things that directly affect the process as it relates to food quality and food safety (SQF Level 3).

So things that are controlled are temp forms, pH testing forms, HTST records, etc.

Things that are not controlled are batch sheets - make orders (though they could be depending on variables), warehouse tags that say what is in a row/bay, etc.

I guess I should really kinda explain that a little better:

For packaging manufacturing things that may be document controlled may be things like carton testing to make sure the ink isn't bleeding into potential product, crush test records on cases anything that tests the ability of your product to protect your customers food quality and safety.

Hello Glass Woman, don't worry we'll handle you with care.

Forget controlling training presentations.

What else would you like not to control? :smile:

Regards,

Simon

Fantastic! I will forget about the powerpoints.  When you start out with the mentality the EVERYTHING MUST BE CONTROLLED :yikes: it's hard to stop controlling documents.

We did have a question on a recent FSSC 22000 audit about document control on job descriptions (which is actually something we don't have document control for).  Has anyone else ever had this brought up as a finding? This is another one that doesn't seem to fit into QMS, but that's all we currently have for document control.  Any suggestions?

Dear Glasswoman,

Welcome to the forum ! :welcome:

I am possibly going to inject some disagreement to preceding post. Spice of Life. :smile:

Yr post is a familiar QA woe but I didn’t completely  understand the content.

If you have successive revisions of an in-use Primary document like Training, how can you keep track without document control, eg version identification ?

Or perhaps yr documentation procedure is not able to be readily implemented due (something).

Or you are effectively a 1-person show, when I  can also get where you are coming from ?

Older versions of iso9001, and their auditing, demonstrated that documentation can become a self-propagating liability. But detail can also genuinely relate to the complexity / risk levels associated with yr business.

However, I can guarantee that if you ever experience any major FS headaches, and most of us will, lack of  adequate documentation can really bite you (and also lack of associated Security :smile: ). Nonetheless, some companies go to, IMO, extremes to cover their commercial “backs”. For example I had one experience where the MD demanded that  the Chiefs of every Section potentially relating to every QA procedure had to approve/sign any revision before it could be implemented. Net result – stasis, and fury.

Basically I suggest you need “good” traceability but without letting the effort to maintain it  bog down yr day. If this is the case, yr documentation procedure probably demands streamlining. Or  more person-power ? .

Rgds / Charles.C

PS - If you think the problem is Form-format related, you might consider posting a (non-logoed) example for comment ?

I oversee the quality management system for a large packaging manufacturing company with several sites throughout the US.

 

We have gotten into a bad habit of putting anything and everything into the QMS.  We feel the need to have document and revision control on everything.  I am trying to help break this habit by defining what is and is not necessary to put in QMS.

 

For example, we have several training presentations that may be related to several TOP/SOP's.  Is a training presentation something that requires document control?  Is there a better system than QMS to ensure the correct version of the presentation is used and accessible?

 

(This is my first post so be nice :helpplease: )

 

Thanks!!

I suppose I should mention that we are ISO 22000 certified in multiple sites, newly FSSC 22000 certified in a few sites, and have no ISO 9000 certified sites (but were previously).

If you are just focusing the FSMS (as having ISO 22000 / FSSC 22000 certified sites) your work will be easier. Just start with the groups of similar type of documents and just ask a question - Whether any change to this group may have a direct or indirect impact on the food safety. If your answer is Yes then that group must be controlled otherwise not.

Second, if you want to go beyond FSMS and want to include the quality aspects too, you have two options.

1- Recommended option for safe side: Apply only tractability controls to documents related to quality aspects. Just keep a records to trace the current version of the important documents.

2- Good practice but need more resources: Apply all controls to important documents as defined in ISO 9001 or similar QMS standard. You definitely have to make a criteria to assess which documents are important with respect to quality and food safety of the product. For example, there would be no sense to control the format of a cash register or a salary slip or a usage summary of office stationary under a QMS+FSMS documentation system.

Regards:

Muhammad Zeeshan Zaki.

We are an ISO 9001 certified packaging manufacturer. 

Our audit house did not require control of the training presentations but one of our major clients required us to 

control them so we did. I guess this also helps especially if the preparer is no longer the one

doing the training presentation.

Yup. We register/ control all QMS and PSMS related docs and temps including JDs.

Hi Guys,

Should MSDS , technical data sheets ans SQA should be controlled?

Rgds,. Rudra

Hi Guys,

 

Should MSDS , technical data sheets ans SQA should be controlled?

 

Rgds,. Rudra

Society of Quality Assurance ??

A rare question indeed.

Rgds / Charles.C