I am in constant contact with validation professionals and often think about what makes people successful in this sector, besides having strong technical skills. It is important to understand what other skills are needed when carrying out such an important role, because ultimately it will have an impact on the result of the work you do. Jim Harper, a highly experienced Validation Engineer, kindly took the time to share his thoughts on how having a collaborative approach is so important:
“When I first became aware of validation I was working in production within a biotech manufacturing organisation and felt, as I’m sure anyone who has been in that role will tell you, frustrated at the time required to carry out qualification and validation exercises when all I really wanted to do was make things. The Quality department, of which validation was part, were quite dismissive of my concerns and said that that was the way it had to be with no further explanation.
I was quite junior at that time and felt annoyed and a bit resentful at the casualness of the attitude toward the production team. As time has moved on my career path shifted to management systems development, to Quality Assurance and then to Validation, where I have now worked for nearly 15 years, I now look back with an understanding of how important these interactions with other parts of the organisation are.
I moved toward validation in my career due to both opportunity and the lure of a systematic and organised approach to work that validation provided. There is a beauty, symmetry and a sense of order when you look at the principles and theory that you want to give to any new project, but I would argue that validation can only be truly effective when everyone involved understands their role in achieving the end result.
Validation is the glue that binds a biotech or Pharma organisation together, whether it is new project, process or product introduction or ongoing compliance with industry standards and requirements. Collaboration between team and individuals is imperative to ensure the organisation is effective in meeting its objectives and when implemented correctly validation can be the lubrication that oils the continually moving parts of the organisational engine.
Validation can be the link between disciplines that explains why the way we do things is important to ensure the quality of a product or process and explain that planning and documentation demonstrates to anyone who cares to look at that the quality organisation operates as intended. This includes helping to ensure;
· Purchasing have the correct equipment identified
· Planning understand the need for validation batches
· Engineering identify criticality of equipment and instruments and tailor calibration requirements accordingly
· Quality Assurance understand the quality critical parameters and their allowable ranges
· Quality Control develop the testing requirements needed to demonstrate compliance with specification
All of the above, and more besides, falls within the different stages of a validation project and requires an understanding by Validation of the functions of others and for the others to understand how validation links each of the functions together. It is my experience that although validation may not be responsible for each of the requirements, they play a key role in explaining the reasons behind them.
If other disciplines are resistant, or don’t understand how it all fits together, the validation professional, if they are doing their job correctly, will have to interact with all them and should explain and ensure others understand how they play their own individual critical part in the process. By validation being the glue within the organisation not only does everyone know their importance and feel valued but will also assist the ultimate aim of a smooth product or process introduction.
This is not a politically correct viewpoint but a point of view that makes life and validation project management easier. Validation enjoys the position of being both a service to other disciplines and as a driver to ensure that those disciplines collaborate effectively. The validation professional has a unique place in any project or operation and should take that opportunity responsibly and use it to bring people together for the common goal.
As I explained earlier, I’ve seen this from both sides and understand that conflict never helps so the validation professional needs to speak to people, including the production technician who doesn’t understand why they can’t make things, and explain the reasons why."
What do others think? If you enjoyed reading this please feel free to share, and I will be interested to hear other ideas.