Risk Management & Process Management

ISO14971 is a risk management standard for medical devices. Its purpose is to help manufacturers to establish a medical device risk management process that they can use to identify hazards, to estimate and evaluate risks, and to develop, implement, and monitor the effectiveness of risk control measures.  

risk managementA large part of FDA compliance is risk management.

I can’t imagine any company that doesn’t assess their risks.  I am sure that there are thousands of ways companies assess risk.  However, if companies are not in medical manufacturing they likely won’t have a documented procedure for managing risk.


ISO14971 calls for a management group to come up with a plan to manage risk.

  • The people on this group will need to be qualified to some standard.  If they are not qualified, they will need to be trained.  They will need to create a training plan.
  • Their responsibilities will need to be defined.
  • The group will put together a process to create/change the risk management plan.  This process needs to be documented and mapped out.
  • All of these activities must be documented.  All of the documents must be controlled and versioned.
  • Any risk management plan needs to take into account safety and hazards.  Safety procedures must be written as well as plans to deal with hazards.
  • Your risk management report must include risk estimations and residual risk analyses.  Again, this must all be documented.

After you have completed all of these activities, you must come up with plans for monitoring your risk management plan.

Obviously, risk management is a required compliance activity for a medical manufacturer.  However, there may be some ideas in here that can be useful to non-medical manufacturers.

I think that monitoring risk is a great idea.  If you have a risk management process in place, employees could enter a change request to alter the risk management process.  This seems like a good strategy to stay ahead of risk.

Risk management and FDA compliance are all about process management.  BPM software that has the ability to manage documents as well would be extremely helpful.

Contact me to learn more…

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By Scott Cleveland @ Cleveland Consulting | October 21, 2014

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