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.
Jim – Agree completely, but quality risk mgt (i.e. FMEAs, Control Plans, etc) are only missing from the other major PLM systems. They are embedded functionality tightly integrated with Parts, Docs, change control, etc inside Aras (http://www.aras.com).
The data model and UI are really complex to implement, so can see why other PLMs don’t have it, don’t try.
It is a critical area for compliance though in Auto (TS/16949 – APQP), A&D (AS9100), Med Dev (CFR Part 820), and other industries as well so the entire supply chain has to do these product risk processes. It’s something that’s really important and has been underserved, don’t you think?
…that is, unless using Aras 😉
Jim – Agree completely, but quality risk mgt (i.e. FMEAs, Control Plans, etc) are only missing from the other major PLM systems. They are embedded functionality tightly integrated with Parts, Docs, change control, etc inside Aras (http://www.aras.com).
The data model and UI are really complex to implement, so can see why other PLMs don't have it, don't try.
It is a critical area for compliance though in Auto (TS/16949 – APQP), A&D (AS9100), Med Dev (CFR Part 820), and other industries as well so the entire supply chain has to do these product risk processes. It's something that's really important and has been underserved, don't you think?
…that is, unless using Aras 😉
Jim – Thank you for the timely article, especially when we are seeing a number of Recalls, Market Withdrawals & Safety Alerts by the FDA ( http://www.fda.gov/Safety/Recalls/ArchiveRecall… )Medical products are developed and used within an intricate system involving a number of crucial contributors: manufacturers who develop and test products; the FDA, which does pre-marketing review, authorization and post marketing surveillance; the organizations providing health care, governments, health care practitioners and patients. Such products are required to be fail-safe, but safety does not denote zero risk – rather is one that has reasonable risks, as judged against the amount of benefit/gain expected and alternatives accessible. All participants in the medical product development and delivery scheme have a role to play in maintaining this benefit-risk balance. As per FDA, most injuries and deaths associated with the utilization of medical products result from their known side effects – some are unavoidable, but others can be prevented or diminished by vigilant product selection and usage. Other sources of preventable adverse events are medication or device errors, and product defects. Another category of potential risk involves the remaining uncertainties about a product like unexpected side effects, unstudied uses and unstudied populations.The FDA recognizes ISO 14971 as an acceptable risk management model. Even if the makers choose not to implement ISO 14971, they are still expected to conduct and document a risk management process. ISO 14971 specifies procedures for a manufacturer to use in order to be familiar with the hazards involved with medical devices. The process is used to estimate and appraise associated risks, manage these risks, and keep an eye on the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. Implementation of ISO 14971, proactive quality risk management, making information retrieval and reuse easier, post marketing vigilance and reporting, and the implementation of Good manufacturing practice, Good Laboratory Practice, Good Clinical Practice etc results in better prevention of defects, higher quality, and reduces cost of poor quality including claims, complaints, and rework.Superior risk management is an imperative part of the industry. The extent of business damage due to recalls, warning letters, seizures, criminal prosecution by FDA are exponentially higher than the quantum of investment needed for a first-rate knowledge capture/management solution.
Thanks,
Jyotirmoy
http://in.linkedin.com/in/jyotirmoydutta
Jim – Thank you for the timely article, especially when we are seeing a number of Recalls, Market Withdrawals & Safety Alerts by the FDA ( http://www.fda.gov/Safety/Recalls/ArchiveRecall… )
Medical products are developed and used within an intricate system involving a number of crucial contributors: manufacturers who develop and test products; the FDA, which does pre-marketing review, authorization and post marketing surveillance; the organizations providing health care, governments, health care practitioners and patients. Such products are required to be fail-safe, but safety does not denote zero risk – rather is one that has reasonable risks, as judged against the amount of benefit/gain expected and alternatives accessible. All participants in the medical product development and delivery scheme have a role to play in maintaining this benefit-risk balance. As per FDA, most injuries and deaths associated with the utilization of medical products result from their known side effects – some are unavoidable, but others can be prevented or diminished by vigilant product selection and usage. Other sources of preventable adverse events are medication or device errors, and product defects. Another category of potential risk involves the remaining uncertainties about a product like unexpected side effects, unstudied uses and unstudied populations.
The FDA recognizes ISO 14971 as an acceptable risk management model. Even if the makers choose not to implement ISO 14971, they are still expected to conduct and document a risk management process. ISO 14971 specifies procedures for a manufacturer to use in order to be familiar with the hazards involved with medical devices. The process is used to estimate and appraise associated risks, manage these risks, and keep an eye on the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. Implementation of ISO 14971, proactive quality risk management, making information retrieval and reuse easier, post marketing vigilance and reporting, and the implementation of Good manufacturing practice, Good Laboratory Practice, Good Clinical Practice etc results in better prevention of defects, higher quality, and reduces cost of poor quality including claims, complaints, and rework.
Superior risk management is an imperative part of the industry. The extent of business damage due to recalls, warning letters, seizures, criminal prosecution by FDA are exponentially higher than the quantum of investment needed for a first-rate knowledge capture/management solution.
Thanks,
Jyotirmoy
http://in.linkedin.com/in/jyotirmoydutta
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