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Q&A

Session with Bud Weightman


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 Q1s 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.

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