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class i medical device, document control, process documentation, forms and templates (general), document revisions and changes, medical devices
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  Post Number #1  
Old 18th November 2010, 01:06 PM

Total Posts: n/a
Please Help! Revising Procedures, Process Documentation and Forms - Questions about

Hi. I have recently taken over the QMS for a class 1 medical device company. I found most of the procedures, processes and forms must be entirely rewritten/reformatted. Apparently the people before me copied and pasted from another company's manual (even forgetting to change the company name in some documents) How do I show the changes without highlighting the entire document?
Any help would be appreciated

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  Post Number #2  
Old 18th November 2010, 01:12 PM

Total Posts: 268
Re: Questions about revising


Our company includes a revision page that tracks the revision number or letter, date, a brief description, and who approved the change. At first many folks thought this was not needed and just another frivolous task, but after years go by it is the only way to preserve the progression from where we were to where we are and why.

In health and safety related industries it is often essential to help when litigation occurs. Best of luck!
Thanks to Sturmkind for your informative Post and/or Attachment!
  Post Number #3  
Old 18th November 2010, 01:45 PM
George Weiss

Total Posts: n/a
Re: Questions about revising

Make a correction plan, and begin the editing of the QM first, and connected documents second. This might be grounds for a Corrective Action, (a NC, non-conformance). This way you can document the plan & progress you make. The effort can not be completed overnight, and you show you are on course to corrected. This would give you and an auditor a picture of the revitalized QMS plan and event.

Thanks to for your informative Post and/or Attachment!
  Post Number #4  
Old 18th November 2010, 02:33 PM
Le Chiffre

Total Posts: 249
Re: Questions about revising

Sounds like a great opportunity. Hopefully the company isn't too jaded from the previous version of the QMS as the documents were obviously not used.

If the editor you're using indicates that entire documents have changed then so be it - call them new documents. They will undoubtedly be more useful than their predecessors. In fact, it may be a good strategy to use a completely new presentation and leave behind any bad impressions that the previous versions created. You will probably encounter people who will object but hopefully enough supporters, too - good luck!
Thanks to Le Chiffre for your informative Post and/or Attachment!
  Post Number #5  
Old 19th November 2010, 05:50 AM

Total Posts: 43
Re: Questions about revising


I don't know if it is standard practice, but I keep a master document with a list of all Quality System Documents, i.e.: the Quality Manual, quality procedures, work instructions, guidance documents, templates, etc.
Something simple: a table with column headings like: "Reference number" (e.g. SOP001, WI0012, etc); "Document Title"; and "Revision number" is enough and allows me to know what is the current status of the QMS.

In the same document I also include another table listing changes made to those documents, including a summary of the changes and the reasons for them. Again column headers would be: "Reference Number"; "Document Title"; Summary of changes; Reasons for changes; Revision number (after the changes are made). It makes my life much easier.

Examples of summary of changes could be:
1. Workflow (and content) changes to separate the supplier approval part of the process.
2. Updated supplier definitions
3. New work instruction

Examples of reasons for changes (for the cases above):
4. Suppliers and acquisitions were confused. Particularly in terms of risk assessments. Motivation for changes arose from internal audit (January 2009). See RCD-0373 #2.17.
5. Updated to keep consistency with Acquisition Process. See RCD-0543
6. Requested further detail from development team. See RCD-0832

Last edited by esalsan; 19th November 2010 at 05:57 AM. Reason: misplaced table
Thanks to esalsan for your informative Post and/or Attachment!
  Post Number #6  
Old 24th November 2010, 04:00 AM

Total Posts: n/a
Re: Questions about revising


I work with a quality system for a medical device manufacturer who were a small start up within a bigger organisation (9001) and have grown massively in a very short space of time.
We have a young system that was designed for a small company and managing the rate of change required to keep up with the business demands can be challenging.
I have a few key tools that I use to cope with this scale of change, which may (or may not!) be of help to you.

The first thing I would recommend would be to design and issue a document control process that works for you and your business. Once you have that in place, changing and implementing change on other documents becomes a lot easier. My document control process includes a list of what is changing and why and also a checklist of questions which forces the person issuing the document to ask. These are things like - what training is required? Do any external parties need to be notified? Are there any regulatory implications? etc.

Like esalsan, I maintain a document master list which gives me an overview of the status of all the documents in the quality system. I also use it to track if any individuals are working on a document at a particular time.

I also have a planning document which lives on an intranet site so that everyone can see it. This is a dumping ground for any ideas that I have or that people request for each of the top level processes. The main advantage I get from this is that everyone can see the planned changes and what is coming up, so it fends off a lot of questions that I would otherwise have to answer!

The last tool I use extensively is formal face-to-face training with small groups. This is part of implementing any major changes and gives everyone a chance to ask questions and gives me confidence that the change has been understood and adopted. I find that people are far more likely to genuinely ask about what is confusing them when training is delivered in a small group, meeting room environment than in a lecture style environment and they also feel more able to come and ask questions after the training when it is delivered in this way.

Good Luck with your changes.
Thanks to for your informative Post and/or Attachment!
  Post Number #7  
Old 24th November 2010, 06:21 AM

Total Posts: 1,133
Re: Revising Procedures, Process Documentation and Forms - Questions about

minimal effort could be to conduct internal audit on that area, audit report enlist those deviance and within CAPA process as a correction you make the changes and as a corrective action you establish/update document management process.
  Post Number #8  
Old 24th November 2010, 01:00 PM

Total Posts: n/a
Re: Questions about revising

@RMortby: Some great ideas I will definitely use...thank you so much for your response...

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