Creo Quality has worked with a variety of medical device clients–from the very early stage startup to the multi-billion dollar multi-nationals. We’ve seen a variety of quality systems. And surprisingly, very few of the quality systems of our clients truly seem to work. Why?
Most companies take a clause-by-clause approach. Meaning, if FDA / ISO has a regulation / clause for a particular item (e.g. document control), the company writes a procedure around this particular item. This approach is repeated for every regulation / clause until all have been addressed in procedure form. And then the result is clunky and cumbersome and does NOT flow well. Also, the result often does a very poor job of really describing how the company does stuff.
Is there a better way? You bet. And my new “friend” from LinkedIn, Rob Packard recently wrote a blog post about it on his blog QC Is Dead (Rob also has another blog RA Review). The blog post is “How to Train an Auditor on the Process Approach”. Nevermind if you’re not an auditor. In fact, it doesn’t matter if you are an auditor or not. And in my opinion, it doesn’t matter if you have an established quality system or not. Reviewing your processes is important. Designing your quality system around your processes is important.
I realize it may be difficult for you to scrap your established quality system and restart. But sometimes, this is a healthy cleansing exercise. Your quality system must mimic what you do as best as possible. I have a couple clients right now where it would be easier to start with a blank sheet rather than try to add and adjust their current approach. But changing old habits is hard.
Keep this in mind, though. Almost any auditor who will be reviewing your processes and procedures will be doing so using the process approach. If your quality system has a flow following a process approach, the auditing (both external and internal) process should flow much more smoothly.
For startups, this is CRUCIAL! You are starting with a blank sheet with respect to a quality system. Build this around processes. And keep in mind, you don’t have to build all processes in the beginning. Bootstrap your quality system. In other words, build it as needed. Rob provides a pretty comprehensive list of processes:
- Design & Development
- Purchasing
- Incoming inspection
- Assembly
- Final Inspection
- Packaging
- Sterilization
- Customer Service
- Shipping
- Management Review
- CAPA
- Internal Auditing
If you are an early stage company, you probably only need to focus on Design & Development (I would throw in Document Control, Risk Management, and Supplier related processes if outsourcing to 3rd parties).