QPack Risk Form According to ISO14971

Rami.Azulay October 23rd, 2012 Posted by Rami Azulay( ) IEC60601, ISO 14971, Risk Management

Following is breakdown of each phase in the risk management process described in ISO 14971:

4. Risk Analysis
4.3. Hazard Identification

  1. Describe the hazard
  2. Select risk category
  3. Define the feature/function hazard relates to
  4. Describe Potential harm
  5. Describe Cause of failure

4.4. Risk Estimation

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The risk level (RPN=Risk Priority Number) is automatically calculated

5. Risk Evaluation

Decide whether risk should be controlled by the predefined acceptability zone (Acceptable, ALARP, Unacceptable)

6. Risk Control

6.2 Risk Control Measures

Define control type

6.4 Final Risk Evaluation – Residual Risk

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The residual risk level (RPN=Risk Priority Number) is automatically calculated

6.6. New Hazard

A new   hazard created? (yes/no)

7. Verification and validation

Evaluation of overall residual risk acceptability

Use QPack traceability to relate artifacts used for risk control.

The test cases (verification) should be connected to design artifacts to assure verification


About the author, Rami Azulay

Rami has over 20 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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