API Q1 adds Risk management to 9th Edition
API Q1 9th Edition adds a new clause on Risk Assessment and Management. It is positioned in the standard clause 5.3 under “product realization”. It has an important bearing throughout the standard and cross-references to Risk Assessment have been made directly and indirectly by other requirements of API Q1 9th Edition.
So what is Expected by this new clause of Risk Assessment and Management :
1 ) The organization is expected to maintain a documented procedure
2) The procedure should identify the techniques (tools) and the process of application of these chosen tools through the stages of identification till risk mitigation.
3) The standard adds a NOTE mentioning considerations of Severity, detectability, and probability of risk
4) Risk assessment has to be carried out for (a) Product Quality (b) Product Delivery
5) Records for Risk Assessment should be kept handy
So How are the other clauses of API Q1 9th Edition linked to this clause
- Risk assessment is a input to the contingency planning ( 5.5)
- Risk Assessment is actively linked to corrective(6.4.2) and preventive action( 6.4.3)
- Risk Assessment is indirectly referenced in planning (5.2)
- As an input to Design and Development ( 5.4.2)
- Preventive maintenance (5.7.8)
- Management of Change (5.11)
- Management Review( 6.5.1)
Although PQP, Product release, and Initial Supplier Evaluation – Critical Purchases – may not appear to refer to risk analysis and management, however in practice it is always required to consult as you prepare or review these
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API-U Specification Q1 9th Edition Training Course Overview for Quality Systems– Fundamentals
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