Priorities

Saftey Culture

1. Safety is a vital tool for business owners to protect their employees. It’s also necessary to safeguard the
company’s bottom line, reduce losses, and achieve and maintain compliance. To ensure this safety is achieved
companywide, a culture of safety must be established.
2. However, a true and effective culture of safety is present only if and when each and every employee, no
matter the level, is responsible for creating and maintaining a safe work environment.
Quality Culture

1. In my view, a true quality culture is an environment where team members genuinely care about the quality
of their work, and make decisions based on achieving that level of quality.
2. You know you have a quality culture when there is a recognition amongst all levels of a company that
quality should be achieved for its own sake, and not just to meet regulatory approval.
3. A true quality culture is, of course, fundamental to making a product that’s safe and effective in order to
improve patient lives. If your team has that in mind at all times, odds are you already have a good quality
culture.
4. Is an organizational value system that results in an environment that is conducive to the establishment and
continual improvement of quality.
5. It consists of values, traditions, procedures and expectations that promote quality

Note :

ESTABLISHING A QUALITY CULTURE

1. Shock
2. Denial
3. Realization
4. Acceptance
5. Rebuilding
6. Understanding
7. Recovery

MAINTAINING A QUALITY CULTURE

1. Maintain an awareness of quality as a key cultural issue
2. Make sure that there is plenty of evidence of the management’s leadership
3. Empower employees and encourage self development and self initiative among them
4. Keep employees involved
5. Recognize and reward the behaviours that tend to nurture and maintain the quality culture
 Components
1. Leadership Commitment & Investment
The executive team must set the tone by making safety a top priority, factoring it into bottom-line goals, and
ensuring their own commitment is clearly visible. They should provide the resources – time, money and
personnel – to achieve results, and be actively involved in safety program activities alongside employees.
Supervisors and managers must lead by example and ensure that workers are trained or certified, as
appropriate.

2. Empowered Employees
All employees must be personally responsible and accountable for workplace safety. For this to happen, they
must feel empowered and comfortable reporting unsafe conditions and providing suggestions for
improvement without fear of retaliation, intimidation, harassment or discrimination.

3. Methods to Identify & Control Hazards

A concrete and proactive process to find and fix workplace hazards is essential to a culture of safety. An
excellent place to start is by conducting a comprehensive safety assessment. Additionally, and more specific
to individual tasks and rolls, is completing a Job Safety Analysis (JSA). These inspections should be completed
periodically or every time there is a change in equipment or processes that could impact safety.

4. Safety Policies & Procedures

In addition to stating the purpose and goals of your safety program, your policies and procedures should
reflect the particular needs of your workplace. They must be stated in clearly understandable terms, and the
reason for them should be explained. Ensure they are reviewed at least annually and updated as necessary.

5. Ongoing Communication, Education & Training

To ensure the sustainability of a safety culture, leadership must remain informed and revise policies and
procedures accordingly. Therefore, an efficient and effective communication system must be developed to
ensure all employees receive timely updates in a language that is easy to understand. Hand in hand with
dissemination of information is ongoing education and training. Even seasoned employees should go through
general and job-specific training as new procedures, equipment, etc. are introduced as well as refresher
training.

6. Continuous Improvement
An organization with a true safety culture will review the safety program’s strengths and weaknesses on a
regular basis. An inspection by a qualified safety professional should be completed at least annually, while
internal, ongoing monitoring and measurement should be conducted to identify areas in need of
improvements. If implemented correctly, continuous improvement is self-sustaining. When employees drive
and achieve gains on a regular basis, it is motivating, builds teamwork and results in organic improvements.
DEFINE AND OUTLINE COMPANY VALUES
1. If you want to raise the standard of your quality culture, or establish a new one, the first thing you need to
do is make sure that your company values are clearly defined. Think about the values your company already
has in place - do these speak to quality? Are these values ones that you want? Is there room for
improvement?
2. As we know through working in the medical device industry, it pays off to adopt a methodical approach.
The process behind your company culture should be no different. Carefully strategize how to go about
fostering your quality culture now in order to set the example for your team, and the natural force behind it
will take hold.
3. One effective way to do this is to encourage employees to adopt a mindset that every product they work
on, regardless of which stage they touch it, eventually will be used on a family member. This approach
establishes a holistic nature to quality culture that will impact all aspects of your business - from product
development all the way to commercialization practices.

TRAIN EMPLOYEES IN QUALITY CULTURE

1. In my opinion, part of this is due to the mindset of those being trained, and I don’t mean that as a criticism.
2. People can undergo all the training in the world, but they need to have an understanding of how their
personal training will be beneficial and actually add value, both to them as an individual and to the company.
3. Training is often mandated through regulatory requirements or disciplinary course of action following an
audit or inspection, but shouldn’t be adhered to as a checkbox activity. Training is an opportunity for teams to
develop new skills that can be used to improve upon products and processes.

PURSUE QUALITY INSTEAD OF CHASING COMPLIANCE

1. Here’s the thing - just because you’re in compliance doesn’t mean you’re producing a quality product. I can
think of fast food restaurants that, on paper, are compliant with regulations, but don’t produce quality tasting
meals.
2. Considering the needs of internal and external stakeholders, which includes patients, will result in such a
high quality that compliance becomes a natural byproduct.
3. I see a lot of companies building a quality system simply as a means to satisfying regulatory requirements,
but this is another missed opportunity to build out one’s quality culture and reap the long-term rewards.

4. Companies that focus on compliance-only tend to view quality culture as a task for the Quality department,
but it must be approached as a company-wide effort. Quality teams are often viewed as separate from the
rest of the organization because they often assume the authority to inspect work, request do-overs, and in
doing so, assume the responsibility for halting progress momentum.
5. Obviously, this isn’t a fair way to view Quality staff members, and it’s a mindset you should be vigilant in
correcting if you come across it within your own company. Your whole organization should embrace a quality
mindset in everything you do, and every interaction across departments.
6. When quality is truly embraced in all facets of a company, you have a better product and fewer headwinds,
it’s as simple as that.
IMPLEMENT DOCUMENT CONTROL EARLY ON
1. Document control refers to the policies and procedures that should be in place to ensure that there is
organizational accountability for records and other data.
2. Document control is fundamental to the success of all medical device companies. Done right, this allows for
scaling, and makes quality repeatable. From a regulatory sense, it’s your way of proving your documentation
is following necessary requirements for compliance.
3. Like quality culture itself, I strongly recommend companies implement their document controls as early as
possible.
4. Early document control can often catch errors and faults that can then be corrected while still in the early
stages, making it easier to keep track of things.
5. Having a good quality management system (QMS) in place can make document control a lot easier. This is
one of the reasons why we created Greenlight Guru, to serve as an electronic QMS that addresses and solves
pain points in processes like document control, an area where it’s much too easy for documents to get lost in
paper-based systems or applications not designed to manage the specific data set required for medical
devices

COMMUNICATE CLEARLY WITH REGULATORS

1. It’s important to align yourself with regulators as much as possible. If you’re not planning and building
systems according to quality standards, your risk of noncompliance is high and will eventually be uncovered at
some point in the process.
2. Regulators are essentially looking for risk in your operations, which is one of many reasons why risk
management and quality management are so closely interconnected.
3. When working alongside regulatory officials during an audit or inspection, you should make sure their visits
are as seamless as possible. This can be practiced and perfected with internal audits amongst all team
members involved in this process. You should always be ready at a moment’s notice to produce any proof of
record or procedure.
4. People tend to get nervous when an audit or inspection is coming up, but this comes down to how
prepared they are themselves. Regulators are not the enemy - they’re simply looking out for the well-being of
your end users.
5. Follow regulation terminology from an early stage and get into the habit of doing it - that way it becomes
second nature, both within your organization and with regulators, to avoid any confusion during an audit or
inspection.
6. Regulatory changes are constant in the medical device industry and internal management of those changes
takes teams away from focusing on innovation. Greenlight Guru takes the regulatory burden off companies
with its medical device specific QMS software that is continually updated to comply with the latest
regulations, including ISO, FDA and EU MDR requirements.
7. By making all of your processes universally understood and straight-forward to regulators, you’ll earn a
considerable amount of time back to use with focusing on producing quality devices that will improve the lives
of your patients.
SEEK END-USER FEEDBACK
1. We've already touched on a critical point of your quality culture involving ensuring at all stages that your
product will have the best possible impact on the lives of your patients.
2. A great way to enhance your quality culture, while also ensuring your product meets quality standards, is by
soliciting end-user feedback. This feedback is invaluable to your process and can help you catch design flaws
that even your most critical engineers may have missed. While most companies seek this feedback well into
the later stages of the project lifecycle, there’s potential benefits to be gained if done properly in earlier
stages
3. You can solicit feedback through focus groups and surveys at any time in your lifecycle journey, and doing
so will have a positive effect on your quality culture.
4. When done effectively, you should seek feedback at multiple stages for the best possible results. Ideally,
you’ll have already placed built-in mechanisms during the design and development process to facilitate this.
You’ll also want to do this at various intervals once the product is in the marketplace to monitor its ongoing
progress
5. This type of proactive approach is prioritized by regulatory bodies and one I frequently recommend
companies take. This can reduce quality issues and create opportunities for being proactive, rather than
feeling forced to take a reactive action, such as CAPA.