Whilst investigating OOS and OOT results is nothing new to Broughton Laboratories, the nature of being a contract QC testing facility has led to some challenging investigations. Trying to meet each client’s requirements, as well as ensuring adherence to regulatory guidelines means that Broughton Laboratories’ own procedure for investigating OOS/OOT results has to be both flexible and robust.
The training delivered by Pete further confirmed that our investigation procedure was fit for purpose and reflected the requirements of regulatory agencies such as the MHRA. Hypothesis testing, risk assessments, root cause analysis and of course CAPA all come together to ensure a complete report is available that stands up to the toughest scrutiny.
For me, as a quality representative who routinely reviews OOS/OOT investigation reports, it was great to have external training provided to both Team Leader and Deputy Team Leader levels. These are the team members who write the reports and perform the investigations, so to have the requirements of a good investigation reiterated by a respected ex-QP such as Pete Gough, enforces the QA message of timeliness, thoroughness, scientific accuracy and ultimately patient protection. In less than a month we have already seen an improvement in the language used in reports in terms of detail – which our clients require to make the right decisions for their products.
An excellent part of the training was a question and answer session where our members could bring examples of investigations (confidentiality maintained of course!) that have proven to be challenging. Pete offered guidance on what he would have wanted to see from a QP perspective as well as the reasoning why, which for team members who don’t often interact with QPs directly was interesting to observe. This also allowed us to probe for responses to some of the vagaries in the regulatory guidelines such as; can re-preparations be performed to test specific hypothesise for destructive tests (re-measuring is not possible for disintegration failures for example)? The answers to which confirmed previous discussions with several clients. This itself led to discussions around root cause determination and the take home message of, “a root cause of analyst error suggests an investigation has not gone far enough” being discussed since by both experienced investigators and those only recently trained.
All-in-all a great days training from a highly regarded trainer, from which we are already seeing benefits. This training will allow us to perform more thorough investigations in a more timely manner as well as help us develop our investigation procedure to meet the needs of a varied and growing client base and those of the regulators.