QUESTION:
From: Yusri
Sent: Aug. 12, 2014
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 5.3, Risk Assessment Requirements

Yusri asks the following questions about API Q1:
API Q1, requires the organization to maintain a documented procedure for risk assessment and management.  What parameters need to be considered for determining risk and their impact on delivery and quality of product?  Should the risk assessment be performed before manufacturing, during manufacturing or after manufacturing?

RESPONSE:
From: ATCS QBlog
Received: Aug. 14, 2014
Hello Yusri,
Thanks for contacting ATCS’s QBlog.  With regard to your inquiry, it’s important to know that API Q1, clause 5.3 “Risk assessment” is applicable product quality and delivery of nonconforming product.  For this reason, risk assessment contingency planning or risk assessment results must be included as part of product “Planning” (clause 5.2) and “Design and development input” (clause 5.4.2) processes.  Risk assessment is inclusive of product planning, design and development, manufacturing and delivery processes.

Although it is not specifically required by API Q1, as a minimum, a risk assessment should identify the risk, risk impact, probability of occurrence, include availability of resources, such as equipment and personnel, materials, manufacturing processes and existing controls or barriers already in place such as procedures and work instructions to minimize impact and/or probability.  See ISO 31000, Risk Assessment and Management for more guidance.

I hope this helps.
Bill Aston, Managing Director