ISO 13485 - Risk Assessment for medical device job shop

M

markuswelbymd

#1
Hello-
A little background on us, we are a medical device job shop. We are registered to 13488 and are transitioning to 13485.
We are currently addressing risk assessment, as it applies to us, so we are looking at the risk to business, since we do not always know the use of the components that we work on.
That said we have decided to focus on assessing risk once a project becomes a transition/production process. In our flow we have R&D =>Transition=>Production.

I was wondering if anyone is facing the same struggle that we are and how have you addressed this?

Any help and/or examples would be greatly appreciated.

Thanks in advance.
Mark Benton
 
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Al Rosen

Staff member
Super Moderator
#3
markuswelbymd said:
Hello-
A little background on us, we are a medical device job shop. We are registered to 13488 and are transitioning to 13485.
We are currently addressing risk assessment, as it applies to us, so we are looking at the risk to business, since we do not always know the use of the components that we work on.
That said we have decided to focus on assessing risk once a project becomes a transition/production process. In our flow we have R&D =>Transition=>Production.

I was wondering if anyone is facing the same struggle that we are and how have you addressed this?

Any help and/or examples would be greatly appreciated.

Thanks in advance.
Mark Benton
It's not just the risk associated with the end use, but what are the risks at each step of the process and their impact to your end product. You would perform a risk analysis on your manufacturing process. What are the risks associated with, missing or improper performance of operations during the process? Does this render your product useless or does it cause a hazard? What has been done to reduce or eliminate the prosibility of it happening? ISO 13485 requires Risk Management throughout product realization.
 

amjadrana

Involved - Posts
#4
Note 3 of section 7.1 Planning of product realization recommends to see ISO 14971 for guidance related to Risk management. Our risk management procedure is based on ISO 14971.

The standard along with amendment 1:2003 details the methods that can be used to carry out risk analysis.
 
P

Pataha

#5
ISO 14971 takes over to its Annex F where it gives you a small statement on the elements of the other commentors. Such as FMEA, Fault Tree Analysis, and Hazard and Operability Study (HAZOP). It, also, has good general safety questions. Beyond this "The Certified Six Sigma Black Belt Primer" has a good section for FMEA. The FDA has HACCP. For development purposes and a quick defense of my approach, I like Ishikawa or Fishbone Analysis. And the Anticipatory Failure Determination(AFD) http://www.triz-journal.com/archives/1999/10/a/index.htm from the TRIZ group are all good at setting up your risk assessment on your approach to the technical file. I use my library for some of this information. As a "medical device job shop", your customers would need to have policies and approaches to be compliant with the FDA and others, if you have a good releationship ask for their polices and samples of their technical files.
Craig.
 
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