Meaningful KPIs and MDR Technical File Requirements
Key Performance Indicators
Recently, I’ve been doing a lot of work on Key Performance Indicators, and one thing I’ve seen is that a LOT of Quality Management Systems (QMS’) have LOTS of metrics, however, very few of them seem key. It’s the the name, you know…Key Performance Indicators…
Here are some of the examples I’ve seen, do these look familiar?
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Number of audits
Number of nonconformities
Number of SCARs closed
These aren’t doing anything for anyone, let’s be honest. Number of audits? Honestly who cares.
Number of nonconformities? I’d like to know how many were major? how many were minor? How many were repeat? How many were on one process area?
Number of SCARs closed? Again, how many were raised?
I’ve put some guidance down for how to develop KPIs below:-
Think about what question(s) you’re trying to answer?
Are the indicators you have leading (inputs) or lagging (outcomes)?
Do you know the difference between measures and monitors and how they’re used within KPIs?
Measures are singular readings of a certain element at a point in time
Monitors are several measures over a period of time
Consider developing target and acceptance criteria, for when KPIs are achieved and archived.
Technical File Checklist
MDR gives far more guidance on technical file requirements as opposed to MDD.
To be safe, it is recommended to utilise the requirements specified within Annex II of the MDR:
Identification of the device (e.g. with a UDI— Unique Device Identifier)
Description of the device, including variants, configuration and accessories
Intended use
Labeling (packaging, instructions for use, etc.)
Information on the design and manufacture of the device
A risk management file
Verification and validation of the device and, therefore, proof that the device meets the general safety and performance requirements
The MDR goes further and includes post-market surveillance (PMS), with planning and implementation, under technical documentation. It establishes the corresponding requirements in Annex III.
Traceability of Directives to Regulations
The following sections of the UK MDR offer some guidance to utilising EU MDR and IVDR as well as the UK MDR/IVDR in tandem and vice versa.
What this means is that by having EU MDR or IVDR, or UK MDR implemented, you can trace conformance to the other legislation➖
30A. Obligations in Part III which are met by complying with obligations in Directive 90/385
44ZA. Obligations in Part IV which are met by complying with obligations in Directive 98/79
It’s incredibly important not to assume compliance between directives and regulations.
The manufacturer should always be able to demonstrate complete traceability and conformance to the particular standard they have declared conformity on.
I’ve covered this in some previously issued newsletters on Compliance Matrices being the best way to do this.