During the last couple of months I have been working with a company that is undergoing a transition as products move through their pipeline – quite a radical shift in strategy. Over the years, their Quality Management System (QMS) has evolved. But as with all evolution, the small incremental changes that occur might lead along a path to an improved system or an evolutionary dead end. With this radical shift, they invited me to come in and assess what they are doing right, what they are doing badly and what, perhaps, they are not doing.
So the first step is a gap analysis which entails reading documents and records and interviewing people. Fortunately, management is highly supportive of this exercise so I got extreme cooperation from all parties. Documents (SOPs policies, quality manuals and quality plans) were supplied to illustrate the systems. In addition, I requested records which were supplied readily. These included deviation investigations, CAPAs and change controls, to name just three types. While I cannot look at all, I asked that typical examples be shown. I want to see the average type record – neither the best nor the worst. During discussions, which ranged from 1 on 1s to small groups, people felt comfortable describing what they liked and what they found frustrating. The interesting feature I noted was that the same frustrations were felt universally across the organization. It did not matter whether it was QA, QC, engineering or production: all felt the same.
The analysis revealed that the three systems described were all weak. While the company used an electronic system to track and manage the system, the end result, the reports, did not meet the requirements of either the practitioners or me. That is, they were neither well written nor clear. They lacked the clear logic to explain what had happened and why for deviations, how the CAPAs linked back to the deviations and the rationale for the change in the change controls. And why was this? In a way the people involved had treated their systems as hurdles that had to be overcome to move to the next step, rather than the tools they should be. With the e-system, it appeared the goal was to move the document from their inbox to next person’s inbox.
They had lost sight that an investigation’s goal should be to:
- Uncover what went wrong, identifying the factors that contributed to the issue (they got some of the factors but not all).
- Recover the material or data (they were good at that)
- Prevent it from happening again (not good at that)
- Prevent similar things from happening elsewhere (almost totally absent)
In this case, the e-system had done a grave disservice to the company. It had taken the thinking out of the process; it had subverted the process from serving the operations to a system that had to be served. It had also driven behavior into short term thinking versus long term. They had cultivated a fire-fighting mentality.
The exact same thing had happened in the change control system. There was not a critical evaluation of any of the changes. The changes were made to save materials rather than build a rugged process or system.
To combat this systemic problem (and all three areas were linked), we embarked on a training session. It included three elements
- Back to basics of the three systems – explaining what the desired state was and how to get there.
- Teamworks which had real life examples of challenges using some of the principles and skills learnt.
- Practical examples from their company. I selected examples of deviations/investigations and CAPAs and change controls and worked through with the group some examples. After I gave my read on the situations, I let them loose to try out the new skills themselves.
During the second round, there was a breakthrough by one of the staff members. Suddenly, the light bulb went off. I have never seen such an excited person in all my years training. I am going back in a couple of weeks to see how things are going. I am quite optimistic. I will keep you posted.
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