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When is ISO 13485:2016 6.4.2 Contamination Control appropriate?

Schkund

Involved In Discussions
#1
ISO 13485:2016 states, "As appropriate, the organization shall plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product."

There are a few different discussions that I've found in the Elsmar Cove forums that include questions on this section, but the topic tends to get overlooked in favor of 7.5.2 - Cleanliness of product. ISO's inclusion of the term "as appropriate" seems to me to indicate that there are circumstances in which this section can be listed as "not applicable" in the scope of a company's quality manual.

When would this section be appropriate and when wouldn't it be? Is this meant to encompass all forms of contamination (chemical, bacterial, etc) or is this section mainly meant for sterile products? For example, if my company makes a low-risk medical device that will not be sterilized and is not likely to be exposed to any hazardous chemicals, should I still be making a process for contamination control?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Cleanliness of product is limited to product. The clause about preventing contamination listed "the work environment, personnel, or product", a much wider scope. See too that sterile instruments are addressed apart from product.

What occurs to me is that some types of contamination could cause a reaction that could affect work environment, personnel and/or product. This could include chemical reactions, but also mold growth or changes in physical properties.

See section 0.2, Clarification of concepts for a discussion about the term "as appropriate."
 

Ronen E

Problem Solver
Staff member
Moderator
#3
To add another perspective, 7.5.2 relates more to the original manufacturing while 6.4.2 is relevant when you get returned goods.
 

Schkund

Involved In Discussions
#4
I definitely understand what you are saying, Jen Kirley, and I agree that the personnel and work environment need to be taken into account, but it seems like most of the articles about Section 6.4.2 from what I can only assume are experts (I could be wrong about that) focus entirely on contamination of the product. Even the FDA requirement most closely associated with this sections states:

21 CFR 820.70(e) Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.

When personnel and the work environment ARE taken into account in these articles, it seems to be in relationship to how personnel and the work environment, if contaminated, could in turn contaminate the product. It seems to me that when it comes to contamination of personnel in and of itself, that would be something that should be addressed as a safety/OSHA aspect rather than a quality procedure UNLESS these authors are right when they state that ISO is ultimately expressing concern that personnel could in turn contaminate the medical devices. Am I making too much of a leap in assuming that?

I am familiar with Section 0.2, I suppose what I was trying to say is that, since the standard provides the opportunity for organizations to justify marking this section as not applicable, when CAN a company do so? It seems to me that there will always be the potential for unexpected sources of contamination in any work environment that could potentially affect the well-being of personnel (like you said, Jen, mold growth... it's not something that you expect to find in your building, but there's a potential it could happen). Perhaps I can read this section as accountability for known sources of contamination or potential contamination and focus on the materials and equipment used directly in our processes? If my company worked with salicylic acid, of course we would need to provide a procedure to address Section 6.4.2. If we used water in our processes, it's still feasible that we would need to account for potential issues involving its use (again, mold growth being a potential issue). If we simply cut dry product into finished shapes and the chances of product or personnel being exposed to contaminants due to the process is slim to none, marking the section as 'not applicable' will be justifiable (so as lot as it is justified in the Quality Manual, everything's kosher). Is that a reasonable way of looking at it?

If my company decides that this is a section we definitely need to take into account, how is this section typically addressed in an SOP? What all is taken into account? I had a look at the resources available to Elsmar members and found a set of sample SOPS, but they were from 2010... as I understand it, the requirement to document a process for control of contamination was added to the 2016 revision. How are companies addressing this requirement in their procedures? In my head I'm seeing something like a matrix or FMEA with a list of potential sources of contamination. The chart would list the severity and likelihood of the contamination happening and list actions taken in response to the ISO standard's concerns... product, personnel, and work environment. Does that seem like an approach that might be commonly taken?
 

Watchcat

Trusted Information Resource
#6
It seems to me that when it comes to contamination of personnel in and of itself, that would be something that should be addressed as a safety/OSHA aspect rather than a quality procedure UNLESS these authors are right when they state that ISO is ultimately expressing concern that personnel could in turn contaminate the medical devices. Am I making too much of a leap in assuming that?
First, it makes sense to me that FDA's regulation would be product focused, because that's the scope of its responsibility. OSHA is responsible for workplace safety and the EPA for environmental hazards. ISO itself has a much broader reach, and it also makes sense to me that this would be reflected in its standards.

Which leads me to the question of why does it matter? I think your company should be complying with all applicable regulations. In most jurisdictions, this would include workplace and environmental regulations.
 

Schkund

Involved In Discussions
#7
Ronen, thank you so much! That is really what I was looking for... something to focus my efforts to ensure I hit the points ISO is requesting without overextending my documentation to cover more than what's needed.

Watchcat, in terms of why does it matter... it certainly is common sense to comply with all applicable regulations. For a small business like the one that I work for, we aren't going to wait until a standard tells us to apply safe practices before we make sure our employees are in a safe environment... the last thing we want is to see someone that we see more than our own family injured on the job. Since the ISO standard requires documentation, my intention was to determine how far our documented procedure needs to extend.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
More of the standards are including mentions of working environment now. 7.1.4 notes in ISO 9001:2015 now describe the clause to also apply to people. Since employee well being can have an impact on performance and thus to product quality, it makes sense to include that. But it's true that you won't see it in 21 CFR 820.70(e).

It can present a slippery slope, as many quality people, including auditors, won't have the Industrial Hygiene training needed to recognize some things; that said, a person need not be licensed to question if mold growth on or in the product is bad for people as well as product.
 

Schkund

Involved In Discussions
#10
Our company had a Microbiology Audit today during which the auditor referenced this portion of the standard with regards to our cleanroom operations... I don't know why it didn't occur to me that our cleanroom procedure could be considered part of this section! I suppose I wasn't thinking of particulate as contamination in the same way that bacteria, mold, or chemicals would be contaminants.
 
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