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  • 1.  QMS - Changing the company's quality culture

    This message was posted by a user wishing to remain anonymous
    Posted 05-Feb-2020 08:48
    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!

  • 2.  RE: QMS - Changing the company's quality culture

    Posted 05-Feb-2020 12:30
    Hi there,

    Please send me a private message. 


    Karen Zhou

  • 3.  RE: QMS - Changing the company's quality culture

    Posted 05-Feb-2020 18:41

    I found that a spirit of inclusion, shared responsibility and ownership dramatically helped move from a dictatorial QA structure to a quality culture. I work for a small company, so this was perhaps easier then it might be in a larger organization. 

    For example, when a standard was updated, I held a series of meetings with department managers and interested personnel to brainstorm. I would describe to them what was changing in regulation/standard and what that meant for them. I would then invite them to share how they thought implementation would be most practical and effective. We would then come to a solution together. This also helped with everyone's understanding/awareness of the processes. 

    Good luck!

    Claire Norton
    Spokane WA
    United States

  • 4.  RE: QMS - Changing the company's quality culture

    This message was posted by a user wishing to remain anonymous
    Posted 06-Feb-2020 08:54
    This message was posted by a user wishing to remain anonymous

    I agree with Claire.  I think one of the most important things to remember is that you can't change a culture over night.  You can't expect to overturn procedures and implement them immediately.  You need to basically get the company's buy-in, convince them that these changes are not only necessary but also positive.  The struggle is usually with those that have been with the company the longest - they're used to doing things a certain way, even if that way is not the most efficient or compliant.  

    I would say to keep an open mind, hold meetings with departments and give them a heads up of what's to come.  Let them ask questions, and hear them out if they have any objections.  It will help both you and them come to a mutual understanding and eventually agreement.  Good luck!

  • 5.  RE: QMS - Changing the company's quality culture

    Posted 06-Feb-2020 10:10
    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.


    Ginger Glaser RAC
    Chief Technology Officer

  • 6.  RE: QMS - Changing the company's quality culture

    Posted 06-Feb-2020 15:06

    Great points everyone! To add my 2 cents...

    I have found that providing departmental training is helpful in creating a quality culture shift. In these trainings, I've explained which regulations are changing, and what the intent is behind these changes. That second piece is important to help people understand where quality/regulatory requirements are coming from. Sharing the intent helps break down the "quality is just compliance" mindset that many people (who are not familiar with a good QS) have. A good quality system is not just compliant to the regs, but is a system with best practices and processes that work for your company, to ultimately help you deliver better products to your customers. Also, to echo some of the other points here: don't unilaterally make changes that will affect other departments. Get the stakeholders involved. Explain to them what needs to change and why, and give them a voice and ownership in the implementation of those changes. Map out the new/updated processes. Ask people about their concerns and suggestions, and revise until you can come to consensus on the best way to create good quality processes that not only meet the regs, but that help ensure your product is ultimately safe and effective. That way, all sides can create a process that works for everyone, rather than the Quality department dictating what needs to happen.

    And if all else fails, appealing to the commercial team always helps. Obtaining and maintaining quality certifications is a ultimately a mark of quality for your company - it will help your marketing team promote more product, and it will help your sales team sell more product. :)

    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA