INFORMATION (Procedures, WHO participates in this process?

methods, forms, information, and so on)  Leadership team (assesses

 QP-12—Risk assessment business risks, determines
 Customer satisfaction surveys actions, reviews status at
 Failure mode & effects analyses management reviews)
 Benchmark data  Engineers (assess product risk)
 Management review data  Quality manager (tracks status of
 Opportunities for improvement risk mitigation actions; manages
noted during an internal audit necessary changes to the QMS)
 Employee feedback  Risk mitigation teams

OUTPUTS:
 Continual improvement through
PROCESS: identifying and mitigating risks
Risk assessment to product and business
performance
OWNER:
Quality manager RECORDS:
 Risk assessments
 Risk mitigation plans
 Action tracking
 Management review records

With WHAT? (Machines, tools, parts, What METRICS are maintained to

equipment, hardware, software, and so determine process effectiveness?
on)  Scrap and rework
 Risk management software  Customer satisfaction ratings
 Action item tracking software  Profitability
 Actions effectively completed by
the estimated completion date