Clifford Berry

With a focus on the pharmaceutical industry, Clifford Berry and Amy Wilson discuss how better management of operational risk can lead to improvements in quality.

Does your manufacturing facility experience an undesirable frequency of costly product losses? Are recurring operational issues impacting productivity and morale? Do people believe the causes of these production issues are ‘human error’?

If your answer to any of these questions is yes, it is time for you to Do Quality Differently.

Do Quality Differently will show you:
How to take a systems-based risk management approach to create more operational success.
Practical examples… Show more

Does your manufacturing facility experience an undesirable frequency of costly product losses? Are recurring operational issues impacting productivity and morale? Do people believe the causes of these production issues are ‘human error’?

If your answer to any of these questions is yes, it is time for you to Do Quality Differently.

Do Quality Differently will show you:
How to take a systems-based risk management approach to create more operational success.
Practical examples to guide improvement in your operations.
Ways to apply comprehensive approaches that reveal and address the combination of factors that influence performance outcomes.
The lessons in this book were gathered while integrating human and organizational performance principles and practices at multiple biopharmaceutical companies and manufacturing sites—real-time experiences with frontline workers, support staff, and leaders. Do Quality Differently offers practical guidance for biopharmaceutical manufacturing plants and beyond—anywhere managing risk is paramount. Create positive change in your operation’s performance. Do Quality Differently will show you the way. Show less

This article is the second part of a two-part roundtable Q&A on the topic of human performance in pharmaceutical operations. Part 1 evaluated the underpinnings of human performance and provided advice to those individuals managing rapid production scale-up to support COVID-19 production demand. Here in Part 2, we consider human performance in the context of investigation and CAPA programs.

This article is the first part of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. Part 1 discusses key drivers for human performance improvement, compares lean manufacturing and human performance programs, and provides perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. Part 2 will review human performance in the context of company investigation and CAPA programs. The four participants… Show more

This article is the first part of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. Part 1 discusses key drivers for human performance improvement, compares lean manufacturing and human performance programs, and provides perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. Part 2 will review human performance in the context of company investigation and CAPA programs. The four participants in the Q&A have significant combined experience in manufacturing operations and human and organizational performance. Show less

As an industry, biotech uses a dated manufacturing model for investigations and root cause analysis. While this model has been viewed as mostly effective in the past, as well as satisfying the criteria established by regulators and customers, there are significant opportunities for improvement. The current state of investigations and root cause analysis is self-limiting to continuous improvement as well an ineffective use of limited organizational resources.

The Human Performance… Show more

As an industry, biotech uses a dated manufacturing model for investigations and root cause analysis. While this model has been viewed as mostly effective in the past, as well as satisfying the criteria established by regulators and customers, there are significant opportunities for improvement. The current state of investigations and root cause analysis is self-limiting to continuous improvement as well an ineffective use of limited organizational resources.

The Human Performance Workstream, have identified fourteen recommendations and eleven best practices. The analysis and key learnings contained in this report provide the context and basis for the recommendations and best practices. The information in this report should be viewed as possible solutions to address opportunities for improvement in investigations and root cause analysis, rather than an all-or-none mandate of required actions.

Properly addressing these opportunities will not only improve the velocity and effectiveness of adopting a strong human performance operating philosophy but will ultimately result in enhancing continuous improvement and organizational effectiveness. Show less

In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place?
The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human error is not seen as an opportunity to learn, but… Show more

In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place?
The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human error is not seen as an opportunity to learn, but as something that drains time, money and resources.

Changing this mindset is crucial to a better understanding of how success and failure happen within an organization, and how to improve its potential to anticipate, monitor, respond and learn – the cornerstones of resilience.

As an industry, biopharmaceuticals is immature when it comes to the integration of human performance into operations. The aim of this paper is to accelerate the industry’s maturity by building a greater understanding of what is desired and explaining how to get there. Human performance is believed by many companies in our industry to be a focus on human error reduction, where work outcomes will improve by adding more requirements and coercing people to try harder to be infallible. This archaic approach is not sustainable today and is not human performance.

This paper is specific to our industry. Companies are not likely to have success by copying a program from another industry, such as nuclear. We have provided guidance that has worked within our industry and the unique regulatory space we operate within. If you think you’re doing human performance and it doesn’t look, feel and sound as we have described in this paper, then you are not there yet.

The paper summarizes the team’s shared experience over the last few years and discusses how the performance of teams and whole operations can be improved through investigations and learning, proactive learning and monitoring performance. Show less

Human Performance is an integrated risk management approach to improving systems, that includes human factors and systems safety, that leads to higher reliability and enhanced operational resilience. A clear picture of what Human Performance looks like in biopharma is available from the BioPhorum Operations Group (BPOG), where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool that will help to… Show more

Human Performance is an integrated risk management approach to improving systems, that includes human factors and systems safety, that leads to higher reliability and enhanced operational resilience. A clear picture of what Human Performance looks like in biopharma is available from the BioPhorum Operations Group (BPOG), where members of the Human Performance workstream have defined a blue-sky for the industry. This blue-sky document is both a guide and an assessment tool that will help to identify the steps to effective human performance integration with operations. The effort to improve reliable operations within biopharma using elements of human performance borrowed from other industries has experienced uneven results and slow progress across the last seven years and has been bogged down for multiple significant reasons. These include a mental model that persists within the industry where workers are assumed to be the problem that needs fixing, the mistaken belief that Lean practices (intended to improve productivity & efficiency) is a cure-all and nearly equivalent to human performance, neglecting the need to fundamentally rethink why and how investigations are performed, and truly underestimating the time, effort, strength of sponsor support needed to change how work is designed, executed, and then later learned from. Show less

Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence?

While the current model has been viewed as mostly effective in the past, as well as satisfying the criteria established by regulators and customers, there are significant opportunities for improvement. The current state of investigations and root-cause… Show more

Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence?

While the current model has been viewed as mostly effective in the past, as well as satisfying the criteria established by regulators and customers, there are significant opportunities for improvement. The current state of investigations and root-cause analysis is self-limiting to continuous improvement as well as not an effective use of limited organizational resources. Properly addressing these opportunities will not only improve the velocity and effectiveness of adopting a strong human performance operating philosophy, but will ultimately result in enhancing continuous improvement and organizational effectiveness. Show less