Pharmaceutical

Pharmaceutical

Human Performance From Lab to Launch

Pharmaceutical manufacturing relies on people to deliver a safe and effective product for patients in a reliable and efficient way every working hour.

 Optimising Human Performance  in all areas of your business, including  safety and quality systems, makes it easier for people to work reliably and makes it easier for your organisation to learn and grow.     

For a user centred approach, you might be curious about

 

 

What is Human Performance for Pharmaceutical manufacturing?

Human Performance enables people to succeed rather than stall by looking at the context in which they work. Context drives behaviour. We want to design context and practices that give people an advantage to succeed, rather than set them up to fail.

Human Performance is related to the discipline of Human Factors. Both take a human-centred systems approach to improving work. Rather than putting excessive efforts into training people to cope with poor systems and practices, we try instead to design the system to be more intuitive and user friendly.

For example, a manufacturing site might find the serial dilution in test tubes to be prone to error. Rather than reprimanding and retraining people we can talk to people to find out what the problems could be, what context is driving this behaviour? We might find when we talk to operators they cite frequent interruptions to be a problem. So we might think of interventions to reduce these interruptions. Deeper still we might look at the structure of the task, the cognition involved and redesign and add cognitive support so the interruptions are no longer damaging. Making it easier to get things right

What’s best practice for Human Performance for Pharmaceutical Manufacturing?

It’s an exciting time for Human Performance for Pharmaceutical Manufacturing. There is no agreed upon best practice. We are working with the Chartered Institute of Ergonomics and Human Factors (CIEHF) and lead a special interest group in this area. This builds on the work and public sharing of the Human Performance BioPhorum group learning.

Different sectors have different levels of maturity in implementing Human Factors. We believe that there is a great opportunity for learning across sectors, but also need for adjustment as we transfer knowledge across. One of the things we want to do is develop a roadmap for this area, to give people an overview and structure to know where they are and where they are going.

First Steps: What steps can I take now?

  • We are developing a roadmap and would love to discuss this with you to help you assess your organisation
  • We can use this assessment to help inform where investing in human performance could help your business
  • What quality system or place in the product lifecycle would make sense to start
  • How this might enhance the existing things you do
  • Contact us for an exploration conversation-  we will share our approach and results

What are the benefits of applying Human Performance for Pharmaceutical Manufacturing?

  • Less process deviations
  • Less error
  • Less risk
  • Less regulatory observation
  • More engagement from staff in their work
  • More compliance
  • Better data integrity
  • Improved productivity
  • A competitive advantage

Where to invest? 

From Lab to Launch human performance can be optimised throughout the product lifecycle. Talk to us to find out more about where this can help you.

Where to invest?

Human Performance integrates into existing systems. Making it easier for leaders to improve the system and for everyone to work compliantly and effectively. 

 

  GMP Documentation and Data Integrity  is critial for Pharmaceutical Manufacturing. Without good practices whole batches can be thrown away and production stopped.

Human Performance approach , tools and HRA software will improve

  • Document architecture and design – automatic feature of software
  • SOPs or work instructions in use (ALCOA+)-
  • Risk-informed education including tacit knowledge from staff

Result: Reduce opportunities for error, improve ALCOA+ performance

  Root Cause Anaysis and deviation management is required by the regulators but is also critical for organisational learning. Poor investigations can prevent learning. Integrating human performance helps you delve deeper into the contributory factors and demonstrate the human aspects of how the deviation occurred, including system thinking.

 Result: The investigation or learning team will find it easier to:

  • Identify the real problem(s)
  • Pin point critical tasks and risks.
  • Assess the effectiveness of controls and barriers for different types of error
  • Effectively gather and share experience and tacit knowledge
  • Identify what Performance Influencing Factors “PIF”s are present (again, context drives behaviour)

 Effective CAPA development commensurate with risk and improvement.

CAPA (Corrective and Preventive) effectiveness  demonstrates how you  assure quality and safety and bring confidence to patients and regulators.  It reduces resource and financial burden by preventing repeat issues.

Critical Task Analysis and associated Human Performance tools help the CAPA design team to:

  • Carry out a Pre- CAPA assessment
  • Identify “SMART” CAPA objectives.
  • Create effectiveness measures that can be verified later  

 Compliance and risk management

As you manage risk in the system you can use  Critical Task analysis. An engaging process involving  stakeholders reviewing how the organisation, process, facility, and the workforce come together to succeed at work and where vulnerabilities are.

Human Performance tools including critical task analysis help the organisation to respond effectively to change control, audits, validation exercises  as risk drivers are identified and mitigated.

Find out more about Human Factors Critical Task Analysis (HFCTR) in our FREE 30min mini-course: https://the.humanreliabilityacademy.com/courses/mini-course-on-hfctr

 Organisational learning and competence management

Pharmaceutical manaufacturing is a complex working enviornment. Although documentation is critical it is not always possible, or even desirable to have every detail specified and written down. There is a certain degree of flexibility and bridging that is done by staff to make the system work. Sometimes the gap between work-as-done and work-as-documented is large. Sometimes the value of tacit knowledge in staff that might have taken decades to accumulate is not appreciated until it is gone. Our task-based approach to human performance seeks to understand work-as-done in detail, to articulate and capture tacit knowledge, so it can be part of training the next generation of technicians, operators and engineers. For critical tasks we can specify the skills, knowledge and experience needed to succeed for different task steps, which goes beyond training for general competences and is more systematic than learning on the job.

 Contact us: If you’d like to discuss these ideas further and how we can help you please contact Julie Avery at julie.avery@humanreliability.com

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