Quality Assurance is not a one person or one team business. In exactly the same way that budget control is not only the CFO’s business, keeping a whole organization in compliance cannot be achieved by the QA team acting on its own. The QMS (Quality Management System) of an organization has an impact on most individuals and compliance requires everybody’s ongoing support.
At the very basic level you need people’s commitment to:
• fill and sign those training records;
• be meticulous about inspection forms;
• document contract reviews; and
• create all these other QA records.
That is, if the organization does not want to have a “QA police person” looking over the shoulder of each staff member.
At a more advanced level, QA procedures could become a true driver of quality if people are engaged with it on a higher level:
• What if more people raised their voices when something went wrong and initiated CAPAs (corrective actions and preventive actions)? Probably the CAPA trends analysis would be much more informative.
• What if the R&D team took the lead on defining the Design Control Procedure with the QA specialist providing only guidance? Maybe they would create a procedure that genuinely reflects the way they want to work.
But how do you drive such a level of engagement? Of course, there are means which relate to the organizational structure and culture, but the point of this post is to show that the right IT in place can be a significant facilitator in engaging everyone with QA.
Here’s a couple of examples:
Example 1: QMS entry/initiation points
Some SOPs, like the CAPA procedure, are created to allow input from the field to be gathered into various quality processes. An IT system can make it easier to facilitate this input. In most companies, initiating a CAPA requires filling a paper or an online form. However, people do not need to open a CAPA every day, they will do it only once in a long while, and when this happens they need to be able to do it without effort and without the need to re-learn each time how to fill the form (or where that form is, to start with). In short, filling the CAPA form is a “friction” which has to be removed.
What if a CAPA form could be initiated by a simple email to firstname.lastname@example.org? No requirements on specific subject line or body; these could just be free text. Sure, maybe some information will have to be added at a later stage but at least you have captured the “CAPA initiation moment” and funneled it into the CAPA system, where all the rest of the work can now happen.
Indeed, when we install our QMS we identify those areas where the organization wants to encourage more input and set up those email addresses to create forms in the system, which are then processed via the appropriate workflow. It’s possible you may end up having too many CAPAs or ECOs but that’s another problem….
Example 2: SOP related knowledge base
In reality, many SOPs are written in QA lingo and are not very clear, and although SOP training has to be done it is quite likely that questions will arise when wanting to follow a SOP.
Certainly those questions could be discussed directly with the author and clarified ad-hoc. But, what if these questions and answers would somehow be captured and made available to other people who need to use the SOP? What we are suggesting is that every SOP has its own online discussion board, or online forum. This board will have the official version of the SOP as well as a place for people to raise questions, comments and ideas in relation to the SOP. This approach has the following benefits:
• It captures questions and ideas people have about the SOP and these could be fed into the next version.
• Saves time in answering the same question more than once.
• Helps identify potential champions who have opinions about the SOP and who could be called in to help author the next version.
These examples also emphasize one more point: not only can an IT system drive wider engagement with QA, but it also demonstrates how vitally important those engagement features are. So, when implementing an IT solution for QA, it is not sufficient to check its compliance, it is equally important to evaluate carefully how you can use the system to increase engagement.