21 CFR 820 Compliant way to use Kaizen to address Nonconformances

ValGal

Starting to get Involved
#1
Hey there!

Would you say that there is a 21 CFR 820 compliant way to use Kaizen to address NC in medical device manufacturing?

Any ideas or opinions?

This is in Japan, by the way. I am really uncomfortable with Kaizen so I would love to hear for others!

Thank you for your help!!!!!!!!!!!!!!
 
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v9991

Trusted Information Resource
#2
'Kaizen' could be certainly a tool
* integrated with 'preventive action' section
* this could also be extended to the correction action section; but with a specific time line and focus-area i.e.,root cause)

about the 'part 820 compliant way', need to focus on
* formalize/outline the kaizen steps in the SOP
* record various activities/steps of implementation (evidence!...records)

:2cents:
 
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ValGal

Starting to get Involved
#3
Thank you!

I wanted to make sure that others have "heard" or actually made a Kaizen SOP. The people I am working with seem quite put off on the idea.

Thank you for your help!
 

v9991

Trusted Information Resource
#4
Thank you!

I wanted to make sure that others have "heard" or actually made a Kaizen SOP. The people I am working with seem quite put off on the idea.

Thank you for your help!
IF the question was towards, 'intent'of making the 'kaizen' as a tool for implementation of NC-CAPA ==> would obviously lead to 'integrating same into SOP' an obvious step and appreciable.

this is to enable
* a harmonized and sustainable practice
* retaining the spirit of "doing as it is written and writing as you do it" ; and the level of details could be differed to an annexure which broadly entails the framework, to a 'format' which enables you to evolve a template for implementation steps.
* traceable - audit-able - compliant practice.

IF you meant otherwise, 'feasibility of adopting kaizen as a tool for CAPA system implementation ' without affecting the 'compliance; aspect to regulations/auditability ....==> it can very well be done,

viz., SOP deals with the auditable-minimum-criteria (viz., follow up for completion-timelines, trending of NC, CAPA etc)
and process of kaizen-implementation would be driven outside SOP, with "minimum or even no-reference" to it.

however, personally, the SOP has to have representation to the implementation process/steps. (viz., if the tracking is through SAP or any other software tool, it is required to add an reference in SOP!)
in this case, if we use kaizen! as an improvement tool, it ought to have minimal reference.

:2cents:

supplement response.,

true, SOP for kaizen, or integrating kaizen into QMS would not only raise eye brows, but when implemented in a 'compliant' manner, it would also turn heads;

integration of QMS tool into QMS-systems&processes would really shift the definition from 'compliance to standards' to 'quality_improvement'.
kaizen integration would boost the "continuous improvement" (read preventive actions" process; today this is more or less tightly coupled with the QMS-CAPA, however there is a opportunity ( not long before it becomes a regulatory requirement wrt expectation of Continuous improvement.)
 
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Ronen E

Problem Solver
Staff member
Moderator
#6
Hey there!

Would you say that there is a 21 CFR 820 compliant way to use Kaizen to address NC in medical device manufacturing?

Any ideas or opinions?

This is in Japan, by the way. I am really uncomfortable with Kaizen so I would love to hear for others!

Thank you for your help!!!!!!!!!!!!!!
Why should the "part 820 way" of addressing NC be conflicting with Kaizen in the first place?

If you search Elsmar for "Kaizen" you'll find a lot of interesting (and possibly useful) reading. You'll also find conflicting opinions about Kaizen.
 

v9991

Trusted Information Resource
#7
Why should the "part 820 way" of addressing NC be conflicting with Kaizen in the first place?

If you search Elsmar for "Kaizen" you'll find a lot of interesting (and possibly useful) reading. You'll also find conflicting opinions about Kaizen.
I guess the question is about including 'kaizen' process as part of SOP.
reluctance could be that, it is not required as per 'requirements' ( traditionally/typically the procedures emphasize more on procedure not on tools , )

Further, integrating tool could place further expand the exposure and scope of compliance.!!!
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I guess the question is about including 'kaizen' process as part of SOP.
Kaizen is an approach / state of mind, and also a technique (or set of techniques). Why should there be a problem with the organization adopting it in a formal way, ie capturing it in an SOP? Would doing it without an SOP make it better? I think the opposite, it would only make it less consistent, more prone to arguments and less committed to.

Now, in general there is no conflict between "the part 820 way" and making something that isn't spelled out in part 820 an SOP. A problem may occur only if that SOP requires something that is against an explicit part 820 requirement. The title "Kaizen" is too general to comment on whether or not "making it an SOP" will result in a clash with a part 820 requirement. Make sure that it won't, and it won't... As a general statement, I don't see why a Kaizen implementation should contain such a conflicting requirement.

reluctance could be that, it is not required as per 'requirements'
Yes, that can be an issue - management might question the necessity of a perceived "extra" beyond the regulatory minimum (though in my opinion it's not really an extra). But that's not unique to Kaizen.

traditionally/typically the procedures emphasize more on procedure not on tools
Not sure what you mean. A procedure is just a way of providing instructions/guidance, typically for something sequential. Most methodical tools can be covered by procedures.
 

v9991

Trusted Information Resource
#9
Not sure what you mean. A procedure is just a way of providing instructions/guidance, typically for something sequential. Most methodical tools can be covered by procedures.
:agree:
I take same line here (ref. initial responses); and, in earlier-post I was just reflecting on the counter points from 'practice or trend' of handling SOPs.
 

Ajit Basrur

Staff member
Admin
#10
Hey there!

Would you say that there is a 21 CFR 820 compliant way to use Kaizen to address NC in medical device manufacturing?

Any ideas or opinions?

This is in Japan, by the way. I am really uncomfortable with Kaizen so I would love to hear for others!

Thank you for your help!!!!!!!!!!!!!!
Hello ValGal,

First of all, there is no "21 CFR 820 compliant way". The 21 CFR Part 820 is a regulation and tells us what to do and does not tell "how" to do. The "how" is up to the manufacturer to contain the nonconformities to meet the 21 CFR Part 820.90 requirements.

Kaizen is a Japanese word for "continuous improvement", and agree with Ronen that there is no harm in including the tools in the SOP.

Refer Wikipedia reference-linkKaizen
 
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