Do we have too many operational procedures and are they too long?

M

MtlGuy - 2009

#1
Hi All,

I introduced myself before the holidays and mentioned that I would be asking questions in the new year. Well, here is the first of many (I'm sure).

Background: Our company (80 employees) manufactures medical imaging software only, and does not sell any hardware (computer, medical or otherwise). We meet ISO 13485-2003, have achieved CE marking and are FDA and Health Canada approved. We are due to have our ISO and CE marking surveilance audit the first week of February.
I recently moved into the position of Quality Systems Manager at our company and have no prior experience in quality systems or regulatory affairs. The previous QMS manager has left the company, so I am flying solo. Luckily I found this site and am hoping to learn as much as I can as quickly as possible.

Question: I am reviewing the operational procedures that we currently have in place, and was wondering if they are all needed. We currently have 26 individual procedures, but I'm thinking (perhaps incorrectly) that some of these can be dealt with simply by mentioning them in the Quality Manual (for example, do we need a documented procedure on how we do project management to deal with 7.2 of ISO 13485?).
I found a list of documentation requrements on this site, but was wondering if it is still valid as it states only 7 procedures are required to be documented.

Several of the OPs are also quite lengthy (15-25 pages). After deciding which OPs are necessary, the next step is to create work instructions from the detailed information in the remaining operational procedures in an effort to reduce them to a more manageable 4-5 pages. Does anyone see a problem with doing this?

Thanks for your help.

MtlGuy
 
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Sidney Vianna

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Staff member
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#2
Re: Do we have too many operational procedures?

Several of the OPs are also quite lengthy (15-25 pages).
Indeed they are lengthy.
After deciding which OPs are necessary, the next step is to create work instructions
Be careful before adding unnecessary layers of documentation. Work instructions, just like procedures and any other type of command media should only be developed if they serve a purpose and aggregate value to the process. Question the wisdom of having to develop WI's. They might be required, but you have to assess the complexity of the tasks at hand, vs. the skills and experience of the people performing the tasks.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Re: Do we have too many operational procedures?

Welcome mtlguy! :bigwave:

Standards define a minimum of required documented procedures, and require that other procedures exist (without expressly demanding they are documented) but leave it up to the organization to decide how many are too many or not enough.

Since you meet FDA and Canada requirements I am not surprised that you have 26 procedures. Nor do I disapprove, even if it were my place to do so. Further, the number of pages isn't surprising, especially given the habit to use one for revisions, one for table of contents, etc.

It's really up to your organization, you see. The procedures need to be manageable and they should be useful. Sometimes procedures can be broken down into smaller parts, like work instructions or appendices. If doing that maintains accuracy while making them easier to use, and still maintains control, it seems good to me.

In short, past the minimum to demonstrate conformance, it's up to your organization to decide what's needed and what is manageable.
 

Wes Bucey

Quite Involved in Discussions
#5
One document you might want to take the time to read through is the audit report and findings from the third party registrar that registered your company to ISO13485.

Especially keep an eye peeled for any comments labeled "opportunties for improvement."

My experience with established medical device companies has been that the paperwork is always sufficient and rarely unnecessary to meet business and regulatory purposes, BUT the language used within the documents could use more clarity and succinctness.

I have seen customer correspondence written by ISO 13485 registered companies dated as recently as 2006 which open with this phrasing (common in my GREAT grandfather's time):
""Yours of the 15th in hand. I beg to inform you that our missive of the 11th instant did refer to our reconfiguration of packaging . . ."

(I had to look up a secretarial handbook published before I was born to understand what "the 11th instant" means - suffice to say most people would not understand, especially anyone under 60!)

The primary question in reviewing any of your company's current docmentation, especially about processes and work instructions, should be whether the intended audiences can read and understand and perform the activities and processes contained therein correctly. Jennifer makes an excellent point
It's really up to your organization, you see. The procedures need to be manageable and they should be useful. Sometimes procedures can be broken down into smaller parts, like work instructions or appendices. If doing that maintains accuracy while making them easier to use, and still maintains control, it seems good to me.

In short, past the minimum to demonstrate conformance, it's up to your organization to decide what's needed and what is manageable.
 
M

MtlGuy - 2009

#6
Thanks all for the quick responses. Al, that thread is the one that made me question the need for so many procedures to be documented in the first place.

I don't think 26 procedures are too many for ISO 13485. You can look at this thread where it is also discussed.
The list of documentation requirements I refer to comes from that post. The second section "Required to be Documented" only specifies 7 procedures. I read this to mean that the 7 listed needed a specific document created to address that specific procedure, and that others 'could' be created if needed, or simply mentioned in the Quality Manual or covered in a sub-section of one of the required 7 procedures.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Mtlguy, it is easy to "read into" a standard's clause and derive a meaning that's possibly more complex than intended. In this forum we often discuss and parse some of these clauses. By all means, when you have such a question raise it here and you can get the perspective of our various exposures to systems management.

Best of luck to you in your new job!
 

Al Rosen

Staff member
Super Moderator
#8
Thanks all for the quick responses. Al, that thread is the one that made me question the need for so many procedures to be documented in the first place.



The list of documentation requirements I refer to comes from that post. The second section "Required to be Documented" only specifies 7 procedures. I read this to mean that the 7 listed needed a specific document created to address that specific procedure, and that others 'could' be created if needed, or simply mentioned in the Quality Manual or covered in a sub-section of one of the required 7 procedures.
There are more than seven documented procedures required. I think that those seven and all the additional required procedures can be incorporated into your Quality Manual. Personally, I prefer stand alone procedures.
 
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