“We recognize the confusion these recent events may have caused our customers, our employees, and the public,” Emergent said in its statement. “We acknowledge that there are improvements we must make … to restore confidence in our quality systems and manufacturing processes.”
We’ve all seen by now the latest NYT reporting about Emergent and the mix-up that cost between 13 and 15 million doses of the J&J Covid-19 vaccine. As a human performance practitioner, my hair lit on fire when reading this statement: “An investigation is now underway, but federal and former company officials suspect the lot […]
My friend and colleague Dakota Stad writes on what recent reporting tells us about Emergent’s culture. Dakota’s points are spot-on – these issues start with senior leadership and are not on indicative of any sort of “rogue actors”.
It would be an easy narrative to blame the workers, but as always we should stay focused on building a just culture.
Observation 1: Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel
This one is a real bellwether to me. The failure of the quality unit to ensure a robust computer system validation program was in place, to ensure data integrity. The fact that the three parts to the observation run the gamut from infrastructure to implementation to on-going use stands out that there are significant weaknesses in data integrity as an approach.
Observation 2: Established specifications, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
Observation 5: Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components before disposition
It is like the FDA saw exactly what was going to happen and did nothing to stop it.
This 483 chilled me to the bones reading it. Major failures in quality here. The fact that this was in April of 2020 raises significant concerns in my mind about how Emergent got any contracts for vaccine delivery.
I have written to my congressional representatives demanding hearings. We need to know who made what decisions when. The trust in our regulatory regime requires full transparency and introspection.
Attributable is part of ALCOA that tells us that it should be possible to identify the individual or computerized system that performed the recorded task. The need to document who performed the task / function, is in part to demonstrate that the function was performed by trained and qualified personnel. This applies to changes made to records as well: corrections, deletions, changes, etc.
This means that records should be signed and dated using a unique identifier that is attributable to the author. Where author means the individual who created or recorded the data.
Understanding what role the individual is playing in the task is critical. There are basically six: Executor, Preparer, Checker, Verifier, Reviewer and Approver.