Originally published in 2014
Picture this. We have just welcomed (ok, so maybe we have just accepted) the regulatory inspector on site.
At some stage in the proceeding we all know the inspector will ask to see our training records.
We have the piles of documents ready in the war room - per person, per SOP, per document, etc.
Now, think back to when the training program was set up a few hundred months ago. How did we decide what SOP training we needed and how much training was required?
Instinctively, we decided to train everyone on everything. Why? Well, “just in case” the inspector asks if Sally in research knows about that SOP even though she never ever does that task, it is not in her job description and there are three other individuals who actually do that job.
So, maybe this is a slight exaggeration…right? No, I will exaggerate here and go with the premise that everyone knows a QA person who insisted on everyone being trained on all departmental (and a few others for good measure) SOPs because the FDA was coming and “we’d better be sure”. My question is better be sure of what? That Sally has read each SOP? That Sally has understood each SOP? That Sally knows it exists? We do not often take the time to really think about what we need.
Tip: Take a more innovative approach and prioritize which SOPs are assigned based on two key criteria:
1. The person’s role – in other words how often does the person use the SOP and how important is the task to their role?
2. The potential impact of the SOP - does the SOP have a direct impact on patients (e.g. safety, regulatory data, etc.).
Taking these two criteria together gives us a score that we can use to decide if Sally really needs to read the SOP, how often she needs to be tested on it or if she just needs to be aware it exists (you know, “just in case”).
Sure, it would take some analysis, planning and prioritization upfront (and probably means you need to speak to the QA person and you might be pleasantly surprised) but it would reduce the number of SOPs Sally would have to read, understand and be competent in.
Tell me, do you think Sally would be happy just reading the SOPs relevant to her work, or do you think Sally wants to read more SOPs?
That’s what I thought too!
Skillpad help clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies.
Nathalie Bourgouin, PMP – Vice-President, Skillpad Canada Inc. is a leader in project management and a subject matter expert with an extensive background in risk-based quality assurance processes and training in manufacturing and clinical trials areas.