Quality Risk Management: Missing Link in the Product Lifecycle?


A quick peek into some research on … efficiently mitigating manufacturing risk from Tech-Clarity’s new report Quality Risk Management in Life Sciences: Preventing Failures, Protecting Patient Health. The study reviews two manufacturers’ experiences using Quality Risk Management (QRM) to proactively reduce risk. The report highlights the importance of managing quality in the product lifecycle, and explains how QRM software can be used to efficiently manage risk.

The Research Findings

The manufacturers interviewed, Moll Industries and F. Hoffmann-La Roche, expressed the importance of proactively identifying and mitigating risks in manufacturing. Both companies emphasized the importance of reducing risk from a patient health and safety perspective, but also from a business perspective.

Key findings from the report include:

  • Share Quality Knowledge – Many companies have the information they need to predict and prevent errors from occurring. They typically capture this information poorly, though, or manage the information in documents that are inconsistent and spread across the organization. This makes the information difficult to find and almost impossible to reuse. So manufacturers are doomed to repeat the same mistakes without learning from them. Not only is this ineffective, it is also inefficient because FMEA (Failure Modes and Effects Analysis) and CAPA (Corrective Action and Preventative Action) processes and documents are recreated from scratch and not based on corporate knowledge.
  • Closing the Loop on Quality – Just as I wrote recently about Closing the Loop on Product Innovation, there is a lot of important knowledge in Manufacturing and other departments that can be leveraged upstream. For quality information, this information can be shared with Engineering / R&D to design errors out of the process and also to Quality to develop control plans to build quality into the manufacturing process.

These two findings both point to a key theme – quality lifecycle management (QLM). Quality is one of the more pressing product lifecycle issues, and one that should be addressed in any PLM Strategy. QRM software helps to automate quality management processes such as FMEA and CAPA, and also provide the knowledge management (KM) capabilities required to share information and close the loop on quality. The report provides much more insight from each of the manufacturers, both of which are highly knowledgeable and experienced in QRM.

Implications for Manufacturers

Quality management can’t be a “check off the boxes” process. Manufacturers need to focus beyond compliance and take a business risk mitigation approach to quality. As I said in Expanding PLM’s Purview – Quality and Risk Management, “Quality is an important aspect of any product, and key to the profitability of a product across its lifecycle.” For medical device manufacturers, pharmaceutical companies, and other life sciences businesses – the stakes are even higher. Lives are at stake, and corporate executives can be prosecuted criminally and put in jail. What more motivation does a manufacturer need (short of a nice letter from the FDA)?

I will leave the final word to Wallace Torres of Roche:

Many companies are not in the hot spot right now and will do the minimum, and they will never profit from the process. They will wait until the moment of a major regulatory observation, and this might be too late.”

So that was a quick peek into some recent research on managing risk, I hope you found it interesting. Does the research reflect your experiences? Do you see it differently? Let us know what it looks like from your perspective.

Please feel free to review more free research and white papers about quality management, PLM, and other enterprise software for manufacturers from Tech-Clarity.