How do you design and implement a product quality management system (PQMS)?

Just like organizational values, quality goals are closely tied to company culture and are intrinsically already in it. Getting clarity around what really matters to the organisation across levels, what triggers concern or celebration, what the customers really care about, will help the organisation find its own meaning of quality and, with that, the right quality KPIs. Forcing in some general-purpose objectives or artificial parameters without introspective analysis won't work.

When developing and implementing a PQMS, I recommend defining specific, measurable quality goals in areas such as defect rate reduction, cycle time improvement, customer satisfaction metrics, cost reduction targets, compliance and regulatory goals, and process improvement objectives.

Looking into industrial product quality assurance, its important to have APQP concept since begging of any new product development. Advanced Product Quality plan. Two main things are important to be along APQP management: clear process and procedure & disciplined people.

One thing I have found to be helpful in designing a PQMS is to ensure the following statement: " To say what you do and do what you say" The process approach in QMS should be at every stage of the company business from getting proposal from customers to delivery of products. Once the process approach is implemented then maintaining a quality system can be achieved via following standards such as ISO 9000 & etc..

The Quality requirements will be dictated by the product requirements. If you need a high performing product, a more rigorous QC programme will be required.

The term quality roles should be defined more specifically. It is vague statement. What is needed is to ensure that all employees are trained and have enough qualification and resources to perform their task as required

Once the quality plan is rolled out, the required metrices should be closely assessed as QPIs (Quality Performance Indicators) or in other word we can term as Quality Health checks. These QPIs should be linked with individuals in the cross functional teams as well as the respective processes. Quality indicators can be a part of periodic performance review which may indicative of product quality, process performance & customer (internal and/or external) feedback.

As an example we can think of customer returns as an opportunity for improvement. Analyzing customer return data and identifying root cause of the nonconformance and implementing (RCCA) can lead to a better design and /or manufacturing process and consequently less return and achieving higher customer satisfaction and ultimately better ROI.

You can't implement PQMS once and forget about it because business environments constantly change. New challenges emerge, customer needs evolve, and industry standards may be updated. By continuously monitoring and improving the PQMS, you can adapt to these changes and ensure that your processes remain effective and aligned with your company goals. Ignoring the need for ongoing advancement can lead to outdated practices, decreased quality, and, ultimately, loss of competitiveness in the market.

As ISO 9001 continues to evolve across its various versions, it's important for a Product Quality Management System (PQMS) to encompass discussions on topics such as regulatory compliance, sustainability, health, safety and environment (HSE), risk management, and data management. By including these aspects, a PQMS can provide a more comprehensive coverage of factors that contribute to customer satisfaction.

Choose a tool to manage documents, signatures and training in a way that is compliant, user-friendly and practical for audits. This may be a combination of tools already in use in the organisation. Indeed, better start with something familiar yet a bit clunky and to improve it or replace it later once needs become clearer.