Formality
As I was reading through a recently published FDA Form 483 issued on 12 Aug 2022, the following statement caught my attention: “a patient death occurred while using the…” Reading through observation one, we find that the device had reached its “upper limit of notifications that can be transferred”, causing a delay of ~one week (transmissions were supposed to occur daily).
I immediately began imagining what tools the firm used for Quality Risk Management. Just like in the garage, the ability to fix anything well depends on the tools provided to the mechanic (it’s generally not the mechanic, but the resources available within the garage that matter most)! If the mechanic is only provided a multimeter to fix an electrical fault, then the outcome of the repair will be in commensurate with this limitation. The mechanic will struggle to remove the parts necessary to access the full electrical system to determine potential faults. In my experience, sites that have world-class risk management programs are those that take advantage of the full spectrum of formality (see ICH Q9(R1)), just like a mechanic should have full access to a wide variety of tools, from pliers (less formal) to a multimeter (more formal).
I wonder if combining less formal tools (data & process mapping) at the hazard identification stage with more formal tools at the risk mitigation/acceptance stage could have led the site to identifying, mitigating and controlling this critical risk appropriately? PIC/s provides an excellent roadmap within their guidance “ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION”, which states:
“The QRM process normally consists of several steps including:
Process mapping identifying all inputs, outputs and existing control measures;
Risk Assessment (incl. risk- identification, risk-analysis and evaluation);
Risk Control (including risk reduction and risk Acceptance);
Communication (i.e. the residual risk should be communicated to the regulators and customers);
Regular Review of the risks”
When a site is provided only the most formal tools (multimeter) – they are generally not able to trigger the critical thinking necessary for a successful QRM strategy. Just like the mechanic will never be able to remove the machine parts without the pliers (now only the ability to access the main battery)… What’s in your site’s toolbox? Do you have the full spectrum of tools necessary for success? Don’t be afraid of less formal tools – take another look at ICH Q9(R1) section 5.1 to gain the confidence necessary to expand the tools in your garage – it will pay dividends well into the future.
Perfection was never an option - just do the best you can with the resources you have and you will suddenly find yourself operating a world class manufacturing operation.
