Norbert Teston

I can only back Tim's comment here in understanding risks and drivers. Alongside this, I would recommend to clearly list out all IMPACTED STAKEHOLDERS: think wide! There are the obvious ones: development teams, production, sales, marketing, but then also the not-so-obvious ones: your legal counsel, customs, accounting, warehouses, supply chain, etc... Depending on the nature of the conflict, risks and drivers can come from truly unexpected areas and these teams must be contacted to truly integrate their feedback. once the context is understood, it's important to keep everyone informed as you move into solution brainstorming mode. Limitations might come from very unexpected dark areas of the business...

make sure to involve the teams working in all these areas and make them responsible and accountable for defining processes that are effective and sufficient. You don't want to overbuild systems that will be overwhelming to follow and maintain throughout and where teams will be discouraged to follow.

Make sure to leverage your distribution channels, stores, ecom sources etc and build up a return or complaint structure. Offer incentive for people to return the product if they are defective or if they don't like it, or they don't fulfill their expectations. These are your best customers to leverage because they're not afraid to tell you the truth. Collecting your returned products (not always possible) is another great way to assess how your product performs with use. Collect them, centralize them and show them to the teams. Build a strong reporting system around them so you can track your improvements as well.

I would argue that engaging the staff first and then training them after. It is critical that they also highly contribute to the development of the QMS and perceive it as a management tool for their own operations, that will benefit them on the long run, and not an additional red tape.

Don't underestimate the workload related to the creation and management of documentation throughout your organization. I recommend to clearly allocate the accountability for documentation management, to ensure regular updates but also understand interdependencies between policies/procedures across the organization. Often team find themselves at an impasse when 2 policies dictate contradictory courses of action... thus completely delegitimizing the entire system.

There is so much to learn from analyzing defective products or returns from dissatisfied customers. For all consumer goods industries, I recommend to prioritize the collection of defective products and setup a process of regular in depth analysis of the root cause. In many instances, issues can be tracked back to a gap in your QMS or be resolved by tweaking your QMS and adding/modifying current QA/QC parameters.