MSQ Engineer
Registered
Question:
Is anyone else experiencing feelings of harassment, intimidation, retaliation, or discrimination (HIRD) when trying to report or discuss issues of safety, quality, conformance, or compliance with management?
(Sorry for the lengthy background, the TLDR questions are at the end of the post.)
Background:
I 'grew up' as a mechanical and systems engineer in the nuclear industry where a significant focus is placed on establishing a "safety and quality culture" within the organization (for obvious reasons). I worked for three different companies where the client, customer, or regulator eventually stepped in and issued a "stop work order" as a result of the work environment that managers had created by using time and budget constraints to rationalize ignoring, dismissing, or neglecting safety and quality concerns raised by employees. I eventually gravitated towards quality systems, and I transitioned to the medical device industry a while back to help companies prepare for EU MDR conformity assessments.
For the past few years, I have been helping a small business (~15-20 FTEs) in the US prepare for MDR compliance. It was obvious (and disconcerting) from the start that the organization did not have the resources (both tangible such as time and money, and intangible such as knowledge, expertise, concern, and care) necessary to understand the intent or purpose behind the standards, regulations, and their requirements. Instead, over the past 30-some years of the company's history, management has taken a "only do the minimum required to pass an audit" approach and developed a "we don't have to do anything unless an audit finding forces us to do something" mentality. As time has progressed, the project team dynamics have become absolutely horrendous and toxic (at least for me).
The reason I mention this is that MDR Article 15 requires manufacturers to identify the person (or persons) responsible for regulatory compliance, and Item 5 states:
To me, Article 15 requires companies to implement a 'compliance policy' similar to (or as part of) their quality policy and corporate policies that identifies all employees as responsible for regulatory compliance in some manner or to some degree. That is, although they may assign or appoint a single Person Responsible for Regulatory Compliance (upper case) that is analogous to the Management Representative role, all employees are persons responsible for regulatory compliance (lower case) in some manner or to some degree - similar to the principle that 'quality is not the responsibility of the quality department alone'.
More importantly, Item 5 appears to establish 'something' (let's say 'being responsible' and 'complying with regulations') as a protected activity, which seems to be a significant change for the industry and a major gap for US manufacturers who market products in the EU under the MDR. In the case of my current client, they have a 'traditional' non-harassment policy that addresses protected classes (e.g., race, gender, etc) for EEOC purposes, but it does not cover, include, or address protected activities. In my opinion, this not only exposes the company to potential litigation, but it is also obvious from site visits that the employees exhibit behaviors and symptoms typically associated with a hostile work environment. Top management tends to rationalize this as a result of 'being a small business' and excuses it as 'all small businesses are like this."
I understand that this isn't the best forum to discuss exactly what MDR Article 15 means or how to comply. I am posting here more so to inquire about the 'state of the industry' - is this something that is usually addressed within the industry? Given that there are ~6,000 medical device manufacturers in the US (5,000 of which are small or medium businesses), is this something the industry should be aware of and addressing? Does this present an area of focus or other opportunity for me to help support the industry in my future career, etc?
Thanks for taking the time to read this post, and I will wrap it all up with a few survey questions to get to the point:
State of Industry Survey Questions RE: Organizational Culture & HIRD
Is anyone else experiencing feelings of harassment, intimidation, retaliation, or discrimination (HIRD) when trying to report or discuss issues of safety, quality, conformance, or compliance with management?
(Sorry for the lengthy background, the TLDR questions are at the end of the post.)
Background:
I 'grew up' as a mechanical and systems engineer in the nuclear industry where a significant focus is placed on establishing a "safety and quality culture" within the organization (for obvious reasons). I worked for three different companies where the client, customer, or regulator eventually stepped in and issued a "stop work order" as a result of the work environment that managers had created by using time and budget constraints to rationalize ignoring, dismissing, or neglecting safety and quality concerns raised by employees. I eventually gravitated towards quality systems, and I transitioned to the medical device industry a while back to help companies prepare for EU MDR conformity assessments.
For the past few years, I have been helping a small business (~15-20 FTEs) in the US prepare for MDR compliance. It was obvious (and disconcerting) from the start that the organization did not have the resources (both tangible such as time and money, and intangible such as knowledge, expertise, concern, and care) necessary to understand the intent or purpose behind the standards, regulations, and their requirements. Instead, over the past 30-some years of the company's history, management has taken a "only do the minimum required to pass an audit" approach and developed a "we don't have to do anything unless an audit finding forces us to do something" mentality. As time has progressed, the project team dynamics have become absolutely horrendous and toxic (at least for me).
The reason I mention this is that MDR Article 15 requires manufacturers to identify the person (or persons) responsible for regulatory compliance, and Item 5 states:
To me, Article 15 requires companies to implement a 'compliance policy' similar to (or as part of) their quality policy and corporate policies that identifies all employees as responsible for regulatory compliance in some manner or to some degree. That is, although they may assign or appoint a single Person Responsible for Regulatory Compliance (upper case) that is analogous to the Management Representative role, all employees are persons responsible for regulatory compliance (lower case) in some manner or to some degree - similar to the principle that 'quality is not the responsibility of the quality department alone'.
More importantly, Item 5 appears to establish 'something' (let's say 'being responsible' and 'complying with regulations') as a protected activity, which seems to be a significant change for the industry and a major gap for US manufacturers who market products in the EU under the MDR. In the case of my current client, they have a 'traditional' non-harassment policy that addresses protected classes (e.g., race, gender, etc) for EEOC purposes, but it does not cover, include, or address protected activities. In my opinion, this not only exposes the company to potential litigation, but it is also obvious from site visits that the employees exhibit behaviors and symptoms typically associated with a hostile work environment. Top management tends to rationalize this as a result of 'being a small business' and excuses it as 'all small businesses are like this."
I understand that this isn't the best forum to discuss exactly what MDR Article 15 means or how to comply. I am posting here more so to inquire about the 'state of the industry' - is this something that is usually addressed within the industry? Given that there are ~6,000 medical device manufacturers in the US (5,000 of which are small or medium businesses), is this something the industry should be aware of and addressing? Does this present an area of focus or other opportunity for me to help support the industry in my future career, etc?
Thanks for taking the time to read this post, and I will wrap it all up with a few survey questions to get to the point:
State of Industry Survey Questions RE: Organizational Culture & HIRD
- Do employees of medical device manufacturers understand that HIRD is not necessarily or simply an intent, set of actions, or pattern of behavior as traditionally or colloquially understood? That it is more accurately described as a neurological and biochemical response (i.e., feeling or emotion) in a biological system in response to environmental stimuli or internal conflict that can ultimately be classified as an issue of mental health and wellness?
- Are your employees and managers trained to recognize HIRD when they experience it? Are they taught that they may not recognize what it feels like or realize that they are experiencing it at first, that such feelings or emotions are more often described or understood colloquially as stress, bullying, burnout, and the like?
- Does your company recognize the importance of organizational culture in meeting quality objectives and providing safe and effective products? Do they define or specify the term 'organizational culture' anywhere within their quality management system? Do they have an established policy, program, or procedures in place to measure, analyze, and improve organizational culture?
- Do they recognize the reporting of safety, quality, conformance, or compliance concerns as a protected activity? Do they recognize this activity as a critical and necessary element of continuous improvement? Do they provide any programs or offer any assistance for employees experiencing HIRD? Do they offer any mental health benefits, executive coaching, leadership development, or other training and education to protect employees and managers from its effects?
- To what degree do you experience HIRD while attempting to fulfill your assigned duties? Do you often feel stressed, burnt out, bullied, or exhausted after discussing quality or regulatory requirements or attempting to plan out quality activities?
- To what extent would you describe your work environment as 'hostile', 'toxic', or 'chaotic'?
- Do you work for a large medical device manufacturer (>250 employees), small/medium manufacturer (<250 employees), or independent contractor/consultant? Do you work for or with a US manufacturer who markets products in the EU? Are they already MDR certified or otherwise in the process of transitioning or preparing for full MDR compliance?
