Having had to do this a few times, I will say each situation is somewhat unique. However, there are certainly things that can make it easier...
- It generally works better to work from both the top down and the bottom up. If you are not part of executive management, try and find a sponsor who is. This can be anybody who "gets it" and will help you advocate for change, and it may not necessarily be your direct boss. For instance, in one of my jobs, the CTO and GC were my best allies. If you can't find
anyone on the executive level to help, the job will be much harder. If they are all actively hostile, then, quite frankly, you are not likely to fully succeed - executive teams do have a big role in setting company culture
- As quickly as possible, identify the QS improvements that can have the most i positive impact on the business while limiting negative impacts. Positive impacts can be reducing compliance risks, reducing scrap, making things more efficient etc. Compliance risk arguments work best if your "sponsor" understands these types of risks. Sometimes gathering Warning Letters or the like can help get attention. Try to start by working on these.
- Recognize that you can't "boil the ocean" and that culture change takes time. Keep that entire list of things to work on, but realize you can't shut down the business to get there, and prioritize ruthlessly. Ideally, things that improve provide some bandwidth to work on the next things to improve. Sometimes you really do have to have a 5 year plan.
- Similar to the above, learn to pick your battles. Perhaps you should battle for better DV testing before releasing products more than better complaint investigations. Or maybe the reverse. Assess where the QS challenges are leading to product problems and start there. Wherever you start, hold that line. Eventually everyone will figure out that this is where you stand and do it to limit battles.
- If you can, start with management reviews and ruthlessly use your data. Has every new product you've launched been recalled? Show it. Do you have a 60% rework rate? show it. Is your throughput time excessive because of quality issues? Is it taking 3 years to finish CAPA? Is overdue training endemic? Show the people responsible with data - and bring a recommendation on where/how you want to start addressing it.
- When working bottom up, focus on how whatever it is you want to change can help your peers and/or your teams. Trade favors if you can (if you will help implement this, I will push that through quickly). Build trust and confidence that you understand their goals. Train and explain the "why" of what you are trying to do. Grab the first people who understand (even better if they are informal influencers in the organization) and start working through them.
- Talent - to the extent you have a team and can impact this, assess your team. Get rid of dead weight. Re-organize to better focus on the areas you want improvements - put your best leaders/workers there. Don't keep around people who just want to say "no" but can't propose good ways to have quality and business needs met. Do bring in people that can prioritize and execute.
- Train, teach and reward - assume a lot of your employees have not been exposed to what a good QS looks like. Teach them. Send them to classes, introduce them to people in their area who do it well. You'd be surprised how many run with it - most people want to do a good job. Celebrate as you knock off milestones - make sure people look back year to year and see how much better it is.
- Continue to build your leadership skills. Understand the data on what change processes look like (google HBR and change). Figure out how you leverage best practices around implementing changes. Leaders come from all levels of the organization, and the better you are as a leader, the more progress you will make implementing the changes you believe will add value.
Good luck! It really can be doable, and while it is a huge amount of work, it is also hugely satisfying.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 04-Feb-2020 20:16
From: Anonymous Member
Subject: QMS - Changing the company's quality culture
This message was posted by a user wishing to remain anonymous
Hi All,
I joined a medical device company a few months ago and based on what I've seen so far, I need to stir (dramatically) the QMS to a better place.
I need some tips about how to change the quality culture in the company.
Where do I start?
Many thanks!