Q: Risk assessment associated with product quality shall include: delivery of nonconforming product; is this about risk involved after a nonconforming product is delivered, or is this about risks which cause nonconforming product?

A: Q1 states in part . . .

5.3 Risk Assessment and Management

“The organization shall maintain a documented procedure to identify and control risk associated with impact on delivery and quality of product…

Risk assessment associated with product quality shall include, as applicable:

c) delivery of nonconforming product (see 5.10.1); …”

Q1 section 5.3 is talking about the “prevention” of delivering nonconforming product.

Notification of nonconforming product that has already shipped is covered by the following Q1 clauses:

5.8 Control of Testing, Measuring, and Monitoring Equipment

“…The procedure shall include requirements for the specific equipment type that addresses:

h) when the equipment is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the equipment and product, including maintaining records and evidence of notification to the customer (see 4.1.5.2) if suspect product has been shipped….”

5.10.4 Customer Notification

“The organization shall notify customers of product not conforming to DAC or contract requirements, that has been delivered. The organization shall maintain records of such notifications (see 4.5).”

The Q1 5.3 (c) requirement of “delivery of nonconforming product” relates to ensuring that the documented quality management system includes robust requirements so that nonconforming products are not shipped to the customer. Methods of prevention are inherent in Q1’s requirements. Shown below are a few examples.

Ensuring that:

• All inspections, tests, monitoring, and measuring takes place and that results are traceable to documented acceptance criteria
• All inspection, testing, monitoring, and measuring equipment are calibrated in accordance with accuracy requirements and no out-of-calibration conditions exist
• Quality plans and/or process control documents identify the necessary steps, including hold points for inspection, testing, monitoring, and measuring to be performed
• All personnel performing inspection, testing, monitoring, and measuring activities are competent as required by job descriptions or other company specified requirements
• Where required, inspection and test personnel have regular eye examinations for near distance acuity and the determination of color contrast
• Processes requiring validation (e.g., welding, heat treating, and nondestructive examination) are clearly documented to Q1 5.7.1.5 requirements and the technical requirements for each process
• Analysis of data is performed, trends are analyzed for root cause, and corrective action is taken, implemented, and effective
• Material, parts, and product storage requirements are identified and maintained
• Product packaging meets both internal and customer requirements, as applicable

These are just a few of the examples. A case for the prevention of nonconforming product can be made with each section in Q1.

— Bud Weightman
President, Qualified Specialists, International