It’s May 15th 2017 and I walk into the Diagnostics Development company for the first time as an employee, it was an exciting day for me, new job, new team to integrate myself into and the challenge for this experienced manufacturing quality professional to apply my skills to the Life Science Industry.
The company are now moving forward offering partnerships for Assay Design and Development with a goal of performing under industry standard product development practices ISO13485:2016 Quality Management System and applicable regulatory requirements to overall reduce risk to commercial partners. ENTER ME!
When I set about my plan of action to gain certification to ISO13485:2016, the first thing I need to do was “get everyone on board”. Always a good place to start, if you get their buy into something new then they will assist and support the implementation.
“If you book them, they will come” – The ghost of Jim Morrison in Waynes World 2 (1993)
The arrival of the Project Manager who came from industry with extensive project management experience of IVD development and Manufacturing would form a good collaboration while developing Design, Development and “customer” facing processes.
In 2016, a gap analyse was carried out by an external consultant. Along with this report, I carried out my own gap analysis against the Medical Device Standard and the In-vitro Diagnostic regulations (IVDR), taking into account the current infrastructure and proposed scope of the quality system. The company did have controls in place such as SOPs for critical processes and equipment, training records, Calibration / Maintenance schedules, logging corrective actions and monitored KPIs through scheduled meetings. This was excellent because although not complaint to a certified quality management system, had a limited understanding of what is required to maintain a Quality Management System. This gave me something to build on.
The resulting presentation and workshops that followed this effort was all about the “what, why, when, where, who and how”.
WHAT is Quality Management?
WHY they need Quality Management.
WHEN and WHERE do we need Quality Management?
WHO does this affect?
HOW (What’s in it for you).
Within this work shop we established the effect of the Quality Management System and what benefits it will bring to the organisation and its individuals. Highlighted what they had at present, the gaps that need to be filled for certification such as enhanced Documentation Control, Change Control, Competency in Training, Record keeping, increased control on purchasing and materials, data collection, internal auditing and Corrective and preventive action. I opened that meeting observing negative and ridged body language from most people which continued into the first couple of hours. Questions were asked in a fashion not to understand more but more to question why we need to do certain things. When the workshop finished, well firstly, they thanked me for my efforts and stated they had more of an understand of “what’s ahead”, but what struck me the most was people left not so ridged, they were discussing aspects with each other in a reasonably comfortable fashion. This was purely down to my approach of making it all relevant. This was my first milestone.
“I can teach Japanese to a monkey in 46 hours. They key is just finding a way to relate to the material” – Rubin from the movie “Road Trip” (2000).
When we got on with the implementation itself, it went a lot smoother than I thought it would but not without its challenges. We made sure that we developed the implementation team to have process specialist / most experienced “stakeholders” assisting and focusing on that particular process development. It was important for me to ensure that those individuals understood the clauses of the standard, appraise the current situation and realise the impact on the 5Ms - People (MAN), the process and Equipment involved (MACHINE), the process flow and associated data collection and documentation requirements (METHOD), material purchase and use (MATERIAL) and the environmental aspects (environMent). The resistance came when they failed to see what difference it would make to day to day operations, I, e collecting data (what are you going to do with it? Why retain it for it to be forgotten about? Procedure writing was the biggest pull on resource time. I had to ensure we looked at each area and defined what procedures required updating and creating, who was the right person to do this and devise a plan that firstly suited the authors and reviewer’s but also the overall implementation time. I was challenged on the fact that it won’t change how we operate this piece of equipment and what if we decide to do it different. What if I want to change my notes? By ensuring them of the reasons and benefits of a QMS like framework, consistency to process, audit trail on changes etc…, they went ahead and assisted with the implementation.
We engaged with the Certification body and we had our 1st stage audit in November 2017. The challenge of this audit was not the fact that this was “a brand new system” or “no one in the organisation apart from a couple of people had been though a certification audit before” (we provided auditee survival training), we were presented with auditors who didn’t quite understand that we were not the legal manufacturer and not all projects are geared towards third party manufacturers.
We concluded the 2nd Stage Audit with some minor NCs that were geared towards documentation updates and key process enhancements. We were recommended for certification based on the plans to close the minor NCs which were accepted and approved by the auditor.
We embarked on the project plan to implement actions to close out the minor NCs and were granted certification to ISO13485:2016 with a scope of “The design and development of nucleic acid in vitro diagnostic tests for precision oncology, and infectious disease diagnosis and monitoring”.
So, one year on, we have a certified Quality Management System that provides a framework to consistently and effectively deliver on requirements and drive improvement through increased management focus, progressing IVD projects with commercial partners with standardised processes throughout and enhanced resource management. More commercial partner opportunities in the pipeline.
How did we do it? What was the main ingredients? In my opinion, it was down to the following 4 key elements:
The vision was made clear from the start,
Hiring the right Quality Professional to lead the project,
Getting everyone on board with the project, identifying, working with and coaching the key “stakeholders” and….
Working in unison with your certification body to ensure they understand your business and your audit days are value add from the opening to the closing meeting.
What’s next? “Maintain that system”. I extended the pool of auditors to support the on-going QMS auditing of the system, work with process experts to look for improvements and document them in SOPs etc.., study the IVDR and the Requirements for Clinical Research to enhance our offering as a commercial partner and venture into other industries and certify our premises accordingly.