It’s 11.30am on a Tuesday morning and the phone on your desk rings. You recognise the number, it’s your boss, the VP of Engineering. “Dave, I need a word”. Those five words instantly fill you with fear. The last time he uttered them, you had been briefed on a new project involving the transfer of a production line from USA to China and that 40% of your team were to be relocated temporarily – during your busy time.
“Dave, as you know we’re under pressure to reduce overheads and costs. It’s been decided by corporate that the cost of validation is too high and you have to reduce it by 25% within the next 18 months”.
“We are leaving it completely up to you to decide how you do it”.
This is becoming more and more of a common occurrence in todays’ life science industry. There are a number of options available on how to reduce the cost of validation, and we will give our own opinions on the most effective.
Implementing a Lean Validation approach
A Lean approach to validation involves the delivery of validation services with as little waste as possible. Using Lean methods will have obvious benefits such as lowering costs, reducing waste, have more efficient processes and more satisfied customers. It can also achieve compliance at a much faster rate.
Effectiveness in reducing costs: Highly effective
Reducing the amount of people involved in validation is a tried and tested answer to reducing short term validation costs, but usually causes follow on problems and can, in real terms, increase costs. Less people available means that a backlog of tasks will occur and slow down, impacting on documents approved and ultimately causing production problems.
Effectiveness in reducing costs: Effective short term, causes long term problems
Lower rates paid to contractors/employees
Wage rates across the life science industry are only heading in one direction – up. Any wage or rate reduction will have an immediate negative effect, both in terms of existing employee relations and how new or potential employees and contractors will view you. If an organization is seen as not paying market rates, they become less attractive to work for, recruitment slows down and employees leave for better conditions. This causes a skills shortage and will leave fewer people available for carrying out tasks.
Effectiveness in reducing costs: Not effective
Without a doubt, implementing a Lean method of validation is the most effective way of reducing validation costs. It can require approval from a global perspective if the change in methodology will impact a global QMS. If the change is site specific, it can be implemented far faster, and a more prudent approach would be to conduct it on a trial basis at first