Digging deep – SAR in the archive!
Leo gave me a ring yesterday and he was totally enthusiastic. Do you remember him? Leo is a quality management representative in medical devices and, by accident, he became PRRC too. He is actually a very pragmatic practitioner always striving for effective quality management solutions. So, Leo called me from his mobile directly out of the cellar of his deepest paper archives of quality records. Since a while he was trying hard to re-assemble a technical documentation for a legacy MDD product for MDR submission at his notified body. Unfortunately the whole MDR remediation project turned somewhat into a Search-And-Rescue project for quality records. Now Leo was extremely happy having found paper folders about the existing microbiological monitoring program. As in previous cases before, he wanted to hear my opinion if he could use such historical information for MDR purposes.
Fact: Historical data and information can most often be used to justify current acceptance criteria and quality practices. Historical data includes not only post-market data like complaints but also production data like results from acceptance testing or CAPA.
Leo’s timelines are short, for sure, otherwise we wouldn’t have had a call at Saturday evening. So I decided to help him the coming day as me met for some coffee in his archive onsite. For me it’s clear that a freelancer needs to be there when things are burning and that there is no time to loose, including Sundays. Leo showed me his current procedure for monitoring both production and product bioburden. There were warning limits and action limits as well as timelines given. But still missing were the justifications for all of that. So we digged deep into his paper records and found an old risk assessment as well as tons of monitoring data. For sure, all of it was not sorted and not trended, just pure data. We started to sort the mess and asked ourselves:
Some of the data sheets we found were not traceable as the lot numbers were missing. Some included the article numbers and the time of manufacturing, so at least they were somehow traceable. For that data we were looking to find the relevant batch records and in most cases we were successful and the puzzle became fully traceable data sets. Nice!
Fact: Make sure that historical data is traceable. You may discard the data if it remains unclear, which lots and articles were tested.
Much more difficult was the task to determine the test methods used at the time. In the past, the company did not always use ISO 17025 accredited laboratories and it wasn’t possible to show which test methods were used. Raw data was incomplete or even missing. In many cases we were not able to identify incubation times and media used for the microbiological tests conducted. Some records even included notes about experimental errors without further evaluation. It was unclear if results passed or failed acceptance criteria.
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Fact: Using ISO 17025 accredited test labs will strengthen the reliability of test data as such laboratories have quality systems in place for testing and impartiality. If labs are not accredited the company would do well to conduct audits at the laboratory ensuring adequate quality practices and records. Make sure that any external record will be evaluated by the manufacturer.
Finally we were looking if the test data was current. This actually means that we found a considerable number of tests, were either the underlying standards and/or the production infrastructure changed. However, this data was good enough showing that the microbiological controls at that time were adequate. For sure we found nonconforming microbiological data, but we were able showing that actions were taken in any of those cases.
Fact: You must verify if the historical data can still be used if changes took place. Standards and scientific practices are continuously changing and the manufacturing including its underlying infrastructure may have changed as well.
It was late in the evening when we touched base on the ground of the archive. Piles of paper were evaluated and sorted. Estimated 80% of the old data was of no use anymore, but this actually meant that around 20% of data was found traceable, reliable and current. Leo gave me a smile and was surprised. “I didn’t expect that so much data is available”, he said. “No surprise for me but the typical outcome of such an action”, I replied, “and now we will rearrange the data in a nice summary report for your TD submission”. The next morning I came back to Leo’s company and started writing the summary. Having drunk enough coffee, it wasn’t too difficult to generate trending charts for the different microbiological tests conducted. Following basic methods of control charting enabled us to reconfirm the warning and action levels in place. We were even able to show, that current control points for surface monitoring were determined quite well in past to monitor the most risky areas for microbiological contamination.
Advice: Please present your historical data in a simple and transparent way. Tell the story of the historical data in simple words and straight forward. There is no need at all to hide potential gaps or deviations which may have occurred in the past. Make sure, that your current quality system is strong enough and fully compliant going forward. Be committed and clear to conduct corrections and/or corrective actions if such actions are indicated!
Now, the story above is not real for sure and Leo does not really exist. This case about microbiological data is just an example and it could have been about design control, process validation, sterile packaging, aging or any other stuff as well. In my 20+ years’ experience in medical devices the issue about missing data is a steady recurrence and quite often a road block for product registration. I made good experience with evaluating historical data and presenting such data in a structured manner to notified bodies and/or authorities. Let me know if you need support in such activity! I’ll be there supporting your teams, any time. Remediation of quality management systems and technical data is not just about generating new (and unfortunately too complex) procedures, it is most often thorough and diligent evaluation of historical data followed-up with precise technical writing.
You can find more information on my website www.quality-on-site.com
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