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 220.127.116.11) 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.
- 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 18.104.22.168 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
Who We Are
Qualified Specialists, International (QSI) is a professional consulting, training, and management systems technology firm headquartered in Houston, TX. Founded by R.T. (Bud) Weightman in 1989, QSI has a global presence and has implemented and assessed management systems in over 28 countries world-wide – with certifications ranging from ISO 9001, ISO 14001, OHSAS 18001, API Spec. Q1 / Q2, and more.
Our specialty spans quality, health and safety, and environmental (QHSE), and our products and services have been applied in engineering, manufacturing, fabrication, distribution, service, projects, and operations.
We excel in helping our clients to achieve regulatory compliance, certification, and industry licensing through our superior software solutions, consulting services, and industry-leading training.
Bud Weightman, President of QSI, is an international management systems expert involved with management and technical systems for over 40 years. As President of QSI, Bud is involved with the industry committees responsible for emerging requirements, including: revision of API specifications, leading various API Task Groups, and lead auditor for the accreditation of SEMS Audit Providers through the Center for Offshore Safety. Bud’s experience includes working with ISO 9001, ISO 14000, and OHSAS 18000 management systems, as well as industry-specific certification schemes such as API Q1 and Q2, AS9100, ASME systems, and numerous other standards.
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