Upon discovery and containment of a deviation or non-conformity, the investigation begins. Whose responsibility is it, the one who discovers it or the one who gets assigned to investigate it? In most organizations, it is not the one who discovers the performance discrepancy. It usually gets assigned to an SME or a dedicated investigator if QA has the resources.
The hand-off between the discoverer and the assigned investigator is not always clearly defined and is often vaguely described in the CAPA procedures. And here is where the first misstep has potential to delay the start of the investigation clock. In this third blog of the Deviation and CAPA series, I intend to argue for the importance of the “hand-off” especially if investigations are assigned to SMEs and staff who were not present during initial discovery, containment and notification activities.
Making the Hand-off Formal
The purpose of the hand-off is to acknowledge responsibility for the investigation and review all actions taken up to the current point in time. Given the nature of the event, the significance and urgency to move forward, there can be a lot of confusion, misinformation and misunderstanding of roles, responsibilities and authority.
One misconception that can occur with novice investigators is the lack of awareness that the investigation details can change and should be revised as the investigation unfolds especially the event description.
Please Tell Me the Story (again)
There are 3 main elements in every “story”. Usually a cause and effect flow to the story unfolds and becomes the basis of the narrative that is told or captured in the investigation form. Next are the key variables that reveal the impact. The trick is to recognize and capture them and not get bogged down or distracted in the extra details. And then, there are the two sides of every story. The investigators job is to find the similarities among the interviews especially if there has been a long chain of events occurring before the hand-off.
A second misconception with new investigators is to park all the information in the investigation form as possible drafts and then revise and revise and revise again until they are finished. Alternatively, they could use a tool that is designed to capture and review the details for the event.
The Investigators Hand-Off Tool – Tell Me the Story
The tool is essentially a worksheet to capture, review and collate the answers to the “Universal Problem Solving Questions”.
- What Happened?
- Where did it happen?
- Who was involved?
- When did it happen?
- How did it happen?
- How big is the scope of the problem?
Notice that “why did it happen” is not included. How it happened can easily morph into why it happened if not carefully checked. At this stage of the investigation, root cause analysis is way too early and can misguide the investigation. Investigators in a rush to get their assignments done, need to stay true to the CAPA process and confirm the event details and then finalize the problem as they know it; more about problem statements in a future blog.
“How it happened” is more about how it was found and how it was discovered? “Where it happened” is seeking clues about a breakdown in the process, the procedures, paperwork and/or batch records. Something happened somewhere and the investigation has to first identify what and where before the why. Having these questions answered accurately allows for a richer probable cause identification step and eventual determination of the true root cause(s).
Until the next blog is released, I have a homework assignment for you. Reread your Deviation and CAPA SOPs specifically looking for the roles and responsibilities for the Initiator and the Investigator. Are they clearly written? Ask your assigned Investigators (if this applies at your site) if they follow a hand-off guide or use any kind of fact-finding/event description worksheet. If you are interested in the HPISC