Risk management from the trenches - How are other medical device manufacturers implement ISO 14971 : 2012? What metric, systems, boundaries and calculations do they use? Exploring the conventions used by medical device manufacturers when performing risk assessments according to ISO 14971: 2012

1. Risk Management from the trenches
The Frank Sinatra Report
November 2013

2. Elements
Risk Management from the trenches
 I meet a lot of customers applying EN
ISO14971 using an FMEA approach
 They all claim to be compliant with
EN ISO 14971
 They all use more or less different
approaches and conventions

3. Elements
“I did it… My Way”
 So why are they different?
 14971 gives some guidance on “how”
 A lot is left open to interpretation
 This is a good thing
 Enter… Conventions!
 Conventions are agreements (based on
(usually) some degree of rationality)

4. Elements
Examples on conventions
 Method of identifying hazards
 How are the severity levels graded?
 How is the probability estimated?
 How is RPN calculated? Why?
 What is the RPN threshold for
accetable risks? Why?

5. Elements
Identification of risks
Method for identification
Company A Potential Hazards in Annex D in 14971
Company B Iterate through all Specifications
Company C Iterate through all requirements and specifications, crosscheck against
list of „standard risks“ (similar to Annex D)
Company D Preliminary hazard analysis, analyse essential design output

6. Elements
Severity and Probability
Severity Probability Method to estimate probability
Company A 1-5 1-5
Quantitative, Non linear
Expert Knowledge
Company B 1-10 1-10
Qualitative
Expert Knowledge
Company C 1-4 1-6
Quantitative, Non linear
Expert Knowledge
Company D 1-10 1-10
Quantitative
Documented statistics from
existing products, clinical studies,
expert knowledge, feedback from
customer, usability studies

7. Elements
Risk Priority Number
Forumula Threshold Rational
Company A Sev. x Prob. x Visibility Severity > 3 or RPN > 40 Don‘t know
Company B Sev. x Prob. x Visibility RPN > 100 Default by Risk
Management tool
Company C Sev. x Prob. x Visibility Defined combinations
of severity and
probability
Not given
Company D Sev. x Prob. x Visibility Mitigate as far as
possible
EN ISO 14971:2012

8. Elements
Effects of using conventions
 Flexibile adaptation
 Hot debates
 An authority problem

9. Elements
How to design the “best” conventions?
 Prio 1: save lives, minimze risk
 Prio 2: pass the audit, get the certificate
 Prio 3: least amount of work

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