HR and Quality, joined at the hip

The interface between the Quality and Human Resources departments in pharma and medical devices can be poorly understood by many leaders in both departments. Quality tends to focus on product and process, HR on hiring, benefits, stuff like that. As a quality professional who oversees the training and personnel qualification system, I tend to sit between the two.

A quick summary of some regulations are in order. This is by no ways a comprehensive list.

Regulation	Requirement
ICH E6 R2, 2.8	Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
US FDA 21CFR 211.25	(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Canada C.02.006	Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic, and other training as the Minister considers satisfactory in the interests of the health of the consumer or purchaser.
EU EMA/INS/GMP/735037/201 2.1	All parts of the Pharmaceutical Quality system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
WHO Annex 3-GMP	9.2 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive so as to present any risk to quality. 9.3 Responsible staff should have its specific duties recorded in written descriptions and adequate authority to carry out its responsibilities. Its duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP. The manufacturer should have an organization chart. (also see section 9.6 and 9.7 on key personnel)
WHO Annex 5-GDP 7.2	Key personnel involved in the distribution of pharmaceutical products should have the ability and experience appropriate to their responsibility for ensuring that pharmaceutical products are distributed properly
Guideline on good pharmacovigilance practices (GVP) EMA/541760/2011	Achieving the required quality for the conduct of pharmacovigilance processes and their outcomes by an organisation is intrinsically linked with the availability of a sufficient number of competent and appropriately qualified and trained personnel (see I.B.6.). All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)]. For marketing authorisation holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].
21 CFR 58.29	(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
21CFR 820.25(a)	Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

A few examples of regulations that touch on personnel

This assortment of regulations provides structure for every aspect of employment from how we hire to how we manage people. We can divide this into the following major areas: Curricula Vitae, Job Description, Hiring Process, Training Records, Org Chart, External Job Identification. All informed by the rest of our quality system, especially Process (SOP) Roles and Responsibilities.

Like most things that concern us we want all of this to be consistent and accurate.

Training and Personnel Qualification within the Quality System

Looking at the 2020 FDA 483 data we can see that these regulations are a concern throughout organizations.

Citation Program Area	Reference Number	Short Description	Long Description	Frequency
Bioresearch Monitoring	21 CFR 58.29(a)	Personnel: education, training, experience	Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***	1
Devices	21 CFR 820.25(b)	Training – Lack of or inadequate procedures	Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***	30
Devices	21 CFR 820.25(b)	Training records	Personnel training is not documented. Specifically, ***	18
Drugs	21 CFR 211.25(a)	Training–operations, GMPs, written procedures	Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, ***	18
Drugs	21 CFR 211.25(a)	Training , Education , Experience overall	Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***	14
Drugs	21 CFR 211.25(a)	GMP Training Frequency	GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***	7
Drugs	21 CFR 211.25(b)	Supervisor Training/Education/Experience	Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. Specifically, ***	2

2020 483 citations related to Training and Personnel Qualification

Reaching beyond the regulations, we really need to ensure that a fear climate does not exist inside the organization, what is often called psychological safety. Looking to Deming, quality should extend to the performance check processes, and frankly those that introduce ranking of employees or departments are not the best for a culture of excellence.

There are many transactional differences in the roles, but if quality is not at the table for key decisions on hiring and culture the organization has missed opportunities.

Anger and the job in difficult times

On Wednesday the United States set a devastating new record in the coronavirus pandemic: 3,124 people dead in one day. This was the first time the daily number of deaths has exceeded 3,000 but I fear it will not be the last. There are over 260k deaths in the US so far, over 1.5 million deaths worldwide. This is crippling, and it is difficult to go day-by-day with the pain of this suffering.

And yet, we need to work, support our families and communities. Get the job done. Amidst all that it is important to remember that is important to grieve and it is okay to be angry.

People grieve in diverse ways with different emotions, from anger, to depression to hopelessness, to resentment over what has been taken from them. Combined with the isolation of the pandemic, this is a recipe for poor mental health and poor coping mechanisms. And then there is a question of just how much and what sort of coping is good. Two-hundred-and-sixty thousand people are dead and there is a lot of evidence this is an underreport and a lot more people are going to die.

I hope you understand that I am angry. All day long. And it is a struggle not to bring that anger to work, not to let it twist my relationships. Yet that anger always exists.

I linked earlier this week to an article on mental health. It is particularly important to make this part of our organizations. Burnout must have a systematic fix.

What we need to give permission to, give space to, is a recognition that we are not in an okay state. And it may not be okay for a very long while, long after vaccines are widely available, and we return to the office.

It is okay to have taken a step back from obligations. I have not, for example, been writing much on this blog. It just did not work for me. Be kind to yourself and be okay with the things you must do less of. And when you are ready, go back to it.

Anger and Culture

Our organizational cultures are full of anger. What we must do is work to establish mechanisms to assure that anger is directed at issues or situations, not people. This will build psychological safety, enable good decisions and enhance our problem solving culture.

Some things we should do:

Acknowledge what is happening: Senior leadership needs to be working from compassion and generosity and taking real steps to address.
Treat toxic positivity as a bias: Toxic positivity is the assumption, either by one’s self or others, that despite a person’s emotional pain or difficult situation, they should only have a positive mindset. This is especially important as we have talent discussions, evaluate performance, and perform other managerial tasks.
Have systems around burnout
Focus on decision making quality
Build employee judgement feedback loops

We are not done. This winter will be very hard for many. As leaders we need to be ensuring our organizations can get through this and then leverage what we’ve learned to build a better culture.

Mental Health and Culture

I’ve been thinking a lot today of this article by McKinsey by Jeffrey Pfeffer and Leanne Williams “Mental health in the workplace: The coming revolution.” It is a fascinating read, not just because we are in the midst of this pandemic which has certainly caused a lot of mental health issues, including depression, in many people. I know I’ve certainly been wrestling with it myself. I’m hopeful this issue remains on the agenda as I think it will provide long term benefits to culture.

I’ve written on how we need to build processes to support our employees in issues like burnout. Mental health is definitely a wicked problem, and will require systematic efforts to address. I am glad that the senior leaders I work with are thinking about this, and I look forward to deepening the conversation.

Happy Birthday to Franz Kafka

“I usually solve problems by letting them devour me.”
Franz Kafka, Letter to Max Brod

This blog is named after a great short story by Franz Kafka, a writer who should be read by every Quality professional.

Franz Kafka’s work has huge relevance for management and organization. The characteristics of bureaucracy that we find in Kafka’s fiction are widespread in the real world bureaucracies we find ourselves in, particularly the ambiguity of rules, the existence of informal networks within organizations, and systemic corruption. Reading Kafka has greatly influenced my ideas of organizational sense-making and has shaped many of my ideas on ethical issues and conflicts that arise within organizations. It is no exaggeration to say that Kafka’s name is as closely linked to the notion of bureaucracy as Weber’s, and deserves a central place in all organizational studies. Quite frankly, Quality as a practice and a profession would do well to read Kafka thoroughly.

The Value of Vulnerability

I’ve been thinking of the role vulnerability a lot in light of the current pandemic situation, and so I went back and re-read Professor Brené Brown’s Dare To Lead. In this book she lays out a framework for vulnerability, as a resource in leadership and within the workplace, which can impact the entire culture and creativity of a team.

Professor Brown defines vulnerability as uncertainty, risk and emotional exposure and lays out how vulnerability is essential to enabling collaboration. Leaders need to be transparent about their own challenges and encourage others to share their challenges with the group. Sharing vulnerability creates group cohesion.

At the same time I’m reading this book, I also started a new job and I’ve been in a lot of conversations about how we get folks comfortable with sharing their difficulties in their implementation around quality 4.0 initiatives.

Here’s the thing I want to stress, we can make vulnerability an organizational habit by instituting standard processes like after-action reviews and lessons learned. Building these processes into project lifecycle and our very culture provides a clear, designated space for sharing and vulnerability. By ensuring consistent application of lessons earned we can build this habit honesty, vulnerability, openness, and sharing of information. And through that we can help drive a culture of excellence.

Vulnerability can create space for “productive failure”, as Professor Brown terms it. A tricky thing for people to buy into but a way of thinking and working that turns failure into an opportunity to learn. When you know productive failure is a possibility you may be more inclined to be courageous and try and create something bigger and better despite the risks. When a workforce sees vulnerability named and shared by their leaders, and where they also acknowledge risks of failure but see it as an opportunity for learning they are likely to believe they can mirror some of that themselves.

There are a lot of reasons why organizations are bad at doing lessons learned, but I think at the core there is this unmovable idea that vulnerability is a weakness. It is probably for this reason that we see folks very willing to share their successes in case studies and at conferences, but not so willing to shares misses and failures. Even though we have a lot to learn from that vulnerability.

I’m curious. How is vulnerability expressed in your organization?