Albert Einstein: “Everything should be made as simple as possible, but not simpler”
“Any deviations need to be addressed immediately, so that the learning can be implemented and so that focus is not removed from achieving the schedule.”
What are the processes in your business that kick in after a deviation investigation or a Corrective Action – Preventative Action is signed off and the batch under question is released for sale? Are there any? Or is it business as usual and don’t spare the horses.
Deviations and CAPA’s are unfortunate, and in theory shouldn’t occur in the business if we have everything under control. Unfortunately, these things happen -a machine or services breakdown, human error or both! We need to be ready to deal with them when they arise. Patient safety is paramount and the team must focus is on ensuring the product complies to all specifications before it enters the market. Equally, we need to do everything we can to prevent a re-occurrence and ensure compliant productivity going forward.
What processes are in place to use this opportunity to improve the process. Does your company have a value analysis / value engineering program? Is it documented? Who in operations is allocated to which function, or do we all chase the ball like under 9’s?
There needs to be a process with standard operating procedures in the business for value analysis and value engineering as part of your ongoing continuous improvement program. This SOP must include the steps that deal with deviations and CAPA’s, so that once the investigation is complete, we move automatically into VE phase and make the necessary improvements to the process. These modifications aren’t always to machines and equipment, sometimes our operating procedures or policies can be changed to eliminate errors. A word of warning, don’t over complicate SOP’s keep them as simple as possible so that they are easy to follow, Complexity leads to human error, as does simplicity.
When we are investigating the reasons for the failure, we must find the cause and not fixate on the symptom. In most cases the deviation itself is the symptom, and if we only focus on this, we can be assured that it will happen again.
If we start looking at behaviours over time, systemic structures and mental models, we will start to get a far clearer picture of what is actually happening and the actions we should take. The deeper you go, the greater the team learning and also the more leverage you will have in preventing a reoccurrence.
There are specific questions and tools that will unravel information at each level, and when applied correctly, expose opportunities for improvement. “Mental models” is the most difficult step, but when conquered gives us the greatest leverage. We are constrained by our own beliefs, assumptions, values and paradigms, and we need to be able to place these to one side and have open collaborative dialogue and debate in our teams (Listen and contribute, don’t tell). We must move from the mindset of trying to find the guilty party, to a mindset of identifying the behaviour or structure that allowed the error to occur. When we can do this, we will win the game and create an enjoyable and successful business.