Friday, May 26, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.7.3. QUALITY RISK MANAGEMENT

1.   Risk management should be integrated into all (primary) processes of TEs, including medical donor screening.  Risk management should be used to identify and control risks associated with product quality, reliability and safety.  Risk management processes should result in situations where residual risk is within manageable or acceptable limits.

2.   Risk management principles and methodologies should be incorporated into TE staff training programmes.

3. Risk management should serve as documentation of the rationale for key safety or quality related decisions.  Risk assessment should be used to support better and more informed decisions on improving organisations and processes.

4. Risk management should be used to support decision-making regarding the specific validations that the TE needs to perform.  The risk assessment should highlight the critical points in the processes allowing the development of an appropriate validation plan.

5. The only circumstances where it can be justified that general requirements are not followed is where a decision is based on risk management by the responsible person.  Otherwise all aspects of the EU directives must be followed.

6. Risk management should be based on the following steps:

a)    Risk identification;

b)    Risk analysis;

c)     Risk evaluation;

d)    Risk control;

e)     Risk reduction;

f)      Risk acceptance;

g)    Risk review;

h)    Risk communication.[1]



[1] EU Good Manufacturing Practices Guidelines

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