John Nolan What happens within our process when we are designing a product for a market, and either our expectations or those of our customers constantly change? How do we deal with this to ensure we can deliver customer satisfaction, and also conform to the ISO 9001:2008 standard?
Elsewhere in these pages there is an excellent article about outlining the fundamental differences between “verification and validation”. As well as explaining the basic building blocks of each within a design process, the article stresses the importance of the accuracy of these facets in terms of satisfying our customer and their needs. Whether working toward ISO 9001:2008 accreditation or not, we all know that satisfying customer demand is paramount.
Dealing with changing requirements
Products aren’t always designed to a specific customer requirement. Sometimes we have an idea, take it to a customer who has a “need,” and start the negotiation process with them in terms of what we can produce versus what they require. So, the design process perhaps isn’t always prescribed, but the method of recording the specifics and matching them must be.
Verification and Validation process requirements and principles will stay the same, but recording the changes from both the customer and design aspects are absolutely critical in terms of ensuring your team is wholly focused on a common goal, thereby satisfying the customer needs and meeting the terms of ISO 9001:2008. Therefore, your Statement of Compliance for verification and First Article Inspection (or your equivalent method of checking you have actually produced a product or service that matched both yours and your client’s needs) will still be needed, but the smartest way to monitor changes is by setting up a Change Log.
Change Log principles
A Change Log can be set up for the whole management system, but sometimes for a design company it pays to set one up for each product or design. On your Document Management System, this can simply be a “form” with one revision, which you can update when requirements or specifications change from either side. What is important is that changes are captured, dates and responsibilities recorded, and a review take place regularly to ensure what is committed to is desirable and feasible, and within the team’s capabilities.
Recording the minutes of such a meeting is also a valuable resource for your Quality Management System, and can not only form the basis for you to correctly “verify and validate” at the appropriate time, but a review of such data can provide a sound basis for “Lessons Learned,” which in turn gives the foundation for continual improvement – which lies at the very heart of ISO 9001:2008.
Building Quality assurance and certainty into your process via the Change Log
Using the Change Log during the verification and validation process is critical, when you seek to ensure that you have both accurately captured and actioned all external and internal changes that have been requested, or taken place. But, why wait until the verification or validation part of the process to do this? ISO 9001:2008 places emphasis on customer feedback and customer communication, and where better to do this than during the design and build process? Consider sharing your Change Log with your customer. Why not review the Change Log at a monthly meeting or conference call, where both parties can analyze and review, to ensure the vision of what the product will be is shared, as opposed to any discrepancies or nasty surprises closer to the Verification or Validation “tollgates”?
Taking the principles from ISO 9001:2008 and involving your customer on your design and production journey can bring you closer together, and guarantee satisfaction for your end user. That customer may also be much more likely to embark on their next journey with you, too…
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