Controlled Environment Procedure: Disaster Recovery Plan

T

TCdavid

#1
Hello all,
We are a medical device manufacturer and are preparing for a microbiology audit (seeking ISO certification) to be conducted by BSI. Part of the documentation they will be reviewing, listed under "Controlled environment (clean room) procedures" is "Disaster recovery plan". I haven't been able to find information here specific to that situation. Is it just a misplaced request to see if we have a general business contingency plan prepared (we don't) or are there requirements for recovery plans for clean room disasters (Oops! The HEPA vacuum just exploded!). Any information or example plans (if available) would be greatly appreciated. Thanks in advance!
David
 
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Sidney Vianna

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Staff member
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#2
Re: Controlled environment procedure: disaster recovery plan?

Are you saying that they are mandating you to have a disaster recovery plan, as part of the assessment against ISO 13485?
 
T

TCdavid

#3
Re: Controlled environment procedure: disaster recovery plan?

Are you saying that they are mandating you to have a disaster recovery plan, as part of the assessment against ISO 13485?
Yes, Sidney, and BSI has listed it under "controlled environment procedures". It is part of their "Documentation Preparation Assistance Plan".
Thanks,
David
 
M

MIREGMGR

#4
Re: Controlled Environment Procedure: Disaster Recovery Plan?

Interesting. We don't have a formal disaster recovery plan, either general or ECA-specific.

What would be the logical process of getting to such an inferred requirement?
 

Doug Tropf

Quite Involved in Discussions
#5
Re: Controlled environment procedure: disaster recovery plan?

I don't see such a requirement referenced in either the standard or the guide - ask them where is the "shall".
 

Sidney Vianna

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#6
Re: Controlled environment procedure: disaster recovery plan?

Yes, Sidney, and BSI has listed it under "controlled environment procedures". It is part of their "Documentation Preparation Assistance Plan".
So, probably you can mark it as N/A. ISO 13485 does not require it.

In the past, we've had cases of CB's that started offering "certification" to ISO 14971. Later on, some start misinforming clients that such certification was "expected", as part of the ISO 13485 certification process.

In the last couple of years, we've had entities wasting investing a hefty sum promoting certification to Business Continuity standards, e.g., BS 25999. Apparently, they have not been very successful in pushing such certification scheme onto Industry.

Make sure that you understand clearly where the requirement for a business continuity plan is coming from. Because, from where I stand, I don't see it.
 
T

TCdavid

#7
Re: Controlled environment procedure: disaster recovery plan?

Thanks, everyone. I think I need to ask the folks at BSI for clarification...
 
M

MIREGMGR

#8
Re: Controlled Environment Procedure: Disaster Recovery Plan?

I'm not finding "controlled environment (clean room) procedures" anywhere...is that wording from the NB document only?

In particular, I haven't found it in ISO 14644.

Are they expecting to apply standards to your review other than ISO 13485?

Are you asking for certification in regard to a capability to operate without interruption?
 
A

abd_sg

#10
Re: Controlled Environment Procedure: Disaster Recovery Plan?

DRP in cleanroom;provide back-up AHU to control temp at 22+/-3C and HUMIDIFIER or DEHUMIDIFIER to control %rh from 40% to 60% relative humidity.Predictive maintenance for Hepa Filters(class 100 ,class 1000,class 10k).Proper gowning and de gowning of people...and proper cleanroom smock gown or bunny suits and proper air shower room prior entering the cleanroom. These are some of the things we had done before.

for more info pls. search for this web;
http://nebbaccreditedassociate.org/
 
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