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Control of Nonconforming Product or Service
The quality control or QC department is usually responsible for the management of nonconforming product by implementing and maintaining comprehensive methods and reports for monitoring and measuring the characteristics of the product, to verify requirements are being met throughout the product realization processes, in accordance with quality requirements, as outlined on the quality control plan.
Verification of customer specification, legal requirements, product characteristics, equipment, etc. would be addressed at suitable measurement location points. Inspections or tests resulting in unacceptable or nonconforming products would be recorded, segregated, and adequately identified to prevent further use until disposition.
Notification will be given to applicable managers about relevant functions of the nonconforming product(s), and there may be release or acceptance under concessions by relevant authorities where the product could be reworked or repaired, depending on circumstance. When a nonconforming product is corrected, it will be subject to reverification. Records should indicate the authority responsible for submission and release of products and delivery of services to the customer.
Issues tied with products or services from external providers may be monitored and managed through the supply chain, however it is advisable to have one central area for tracking all nonconforming product, which may be in your nonconformance-corrective action system.
Monitoring includes the control of monitoring and measuring equipment. Performance cannot be accurate if the machinery has not been calibrated and verified to provide the correct measurements.
Analysis of Information
Through the analysis of information comes the insight for change and the need to take action. It is important to have a process in place to manage your changes to ensure resources are assigned and the management system structure is reviewed regarding how this change will impact all areas. This process can be used for changes such as specifications, processes (machine technique), equipment, raw material, or packaging, or any other change.
Monitoring any changes at the organization related to processes, materials, and equipment through the management of change process ensures the review of risks and controls. A reexamination needs to be done after the change as well.
The quality standard revision, ISO 9001:2015, now emphasizes evaluation. An organization will now look to evaluation, and this brings to the forefront requirements to make the organization data-driven so that the monitoring will include evaluation of the data that is being kept.
Evaluation is focused on lessons learned and bringing them into the decision-making process for continual improvement. Here is where the manager looks at data to drive business decisions; therefore, the data needs to be measurable, having key metrics or performance indicators.
The evaluation needs to be objective so that it provides credible information. Evaluation addresses the analysis of data or, digging deeper, looks at root causes and the bigger picture.
Evaluation looks at your business risks and opportunities for the future and the fulfillment of objectives, where transparency is essential for investors, third-party registrars, corporate head offices, and the public, who are interested in the results of something.
Regardless of what monitoring and evaluation you are doing, it is imperative that the data is relevant, reliable, and complete; otherwise you will be making incorrect decisions.
Senior management of an organization analyzes data from various sources to assess performance against plans, objectives, or criteria. The management system itself has systems in place, such as the internal audit process and a nonconforming product and nonconformance system that assist in the analysis and review of your management system.
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