I think we would all agree that the above saying very much applies to addressing any issues with the health of any firm’s Quality Management System. It is far less painful when your own Quality Oversight (QO) system self-identifies events rather than having them pointed out by a regulator during a health agency inspection, which then results in an official citation. Indeed, an agency inspection will tend to go more smoothly if the investigators gain confidence in the capability of the firm’s QO program. So, with this in mind, a question that you should be asking yourself is: What should I consider when evaluating my QO program in terms of its ability to detect and address issues before they become a little more painful? Below is a list of considerations based on our experience (this is, by far, not an exhaustive list, and the order does not reflect the criticality).

      1. Metrics – It is recommended that quality indicator metrics are in place and monitored. The aim is to establish an acceptable “baseline” and then identify a threshold that may indicate there is an underlying/special cause at play, necessitating a CAPA.


      1. Internal Audit/Self-Inspection – Internal audit is a critical program that should be assessed for effectiveness. For example, when evaluating health agency observations, a firm should assess why such an observation was not detected during an internal audit. What is the root cause for why this was missed? Is a program-level CAPA needed?


      1. Management Oversight – How often is management on the shop floor conducting walkthroughs? Is there a procedural requirement that management conducts GEMBA walks during which they observe operations and interact directly with the workforce to see firsthand the issues and challenges? With such a program, it is critical that the outcome is documented with follow-up actions.


      1. Whistleblower Policy – A company should have a clear policy on the reporting of any issues/concerns to senior management in a consequence-free environment where they are addressed per the company’s QMS on a risk-based priority.


      1. Site Quality Council Meetings – There is an expectation that there are SOP-driven site quality meetings attended by senior management during which there are defined agendas covering the review of key site quality metrics along with other items, such as critical deviations, OOX results, stability trends, APR/AQR findings, critical CAPAs, results from internal audits, agency citations, change controls, escalations, etc. Such meetings should have recorded minutes that document outcomes and requirements for follow-up actions. These meetings are essentially discussing the health of the QMS and the need for any program-level CAPAs.


    1. Periodic Workshops – Another consideration is conducting periodic workshops during which publicly available citations are reviewed and the team risk-assesses the potential of receiving a similar citation (and what preventative actions may be required). Such workshops can be an effective component of driving a culture of continuous quality improvement along with other items, such as town hall meetings during which senior management may celebrate recently implemented preventative actions, highlighting the quality pain such actions may have prevented (cf. to a corrective action).

If you have any questions relating to quality oversight, Lachman Consultants can help you! Please contact LCS@lachmanconsultants.com for support with this critical undertaking.