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.

RegulationRequirement
ICH E6 R2, 2.8Each 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 210.25(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.02.006Every 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 2.1All parts of the Pharmaceutical Quality system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.
WHO Annex 3-GMP9.2 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 7.2Key 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/541760/2011Achieving 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 ouch 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 AreaReference NumberShort DescriptionLong DescriptionFrequency
Bioresearch Monitoring21 CFR 58.29(a)Personnel: education, training, experienceNot 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
Devices21 CFR 820.25(b)Training – Lack of or inadequate proceduresProcedures for training and identifying training needs have not been [adequately] established. Specifically, *** 30
Devices21 CFR 820.25(b)Training records Personnel training is not documented. Specifically, ***18
Drugs21 CFR 211.25(a)Training–operations, GMPs, written proceduresEmployees 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
Drugs21 CFR 211.25(a)Training , Education , Experience overallEmployees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***14
Drugs21 CFR 211.25(a)GMP Training FrequencyGMP 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
Drugs21 CFR 211.25(b)Supervisor Training/Education/ExperienceIndividuals 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.

As we end the year it is a good idea to think about this question in your organization. I’ll be expanding on the practice in the weeks ahead.

Facilitation Planning for the Unconference

Some thoughts on how the agenda I pulled together for the 29-February-2020 ASQ Team and Workplace Excellence Forum Unconference.

Kick-Off/Introduction

A good session starts with pulling people out of their comfort zone and getting the energy level right. When building the Unconference agenda I planned for there being people I didn’t know (and I’ve been proven right!). As a facilitator I always want to get people on the right track, and for this introduction I want to go fast so I planned two activities:

  • Draw the neighbor and share. Okay I am the worst at drawing. Think of how bad you are, and I am worse – stick figures are hard to get right. But I love drawing icebreakers for the simple reason that they help get us in a fun place and out of day-to-day. The folks who come to the Unconference are giving up their Saturday and I want to let them at once know this will not be business as usual.
  • Ridiculous “How Might  We”: Start with the funny and ridiculous and you prime the pump and let folks know that we are going to be safe and creative today.

Back of the Napkin

Break into teams of 3 people and answer the question “What does Team Excellence look like” and write/draw it up on the back of a napkin. This allows us to introduce ourselves, and do some networking while at the same time starting to grapple with the core question of the day (and of the Team and Workplace Excellence Forum!)

The back of a napkin is already associated with Aha moments and inspiration.  This informal exercise helps combat people’s instincts towards worrying about whether they can draw, have the “perfect” solution to the question, and other worries that can crop up if we were to use something more formal. This game is meant to inspire conversation and ideation – two things I’m really looking forward to.

Open Space Technology

The heart of an Unconference. Harrison Owen described this methodology in his book Open Space Technology: A User’s Guide. This process is a good match, and I’m pretty excited about this as an experiment. Owen set forth five reasons to use Open Spaces:

  1. There is a genuine business issue: I feel a real urgency around the ASQ’s Team and Workplace Excellence Forum (perhaps the ASQ in general). There is a buring platform of building better culture in our organization, and it is coupled with a person feeling that I have about 18 months to make this division relevant.
  2. A great deal of complexity: Workplace excellence and quality culture are not easy; they are not simple. I am fairly sure that any three reasonable people will find a lot of things to disagree on.
  3. Lots of diversity in terms of people and points of view: This was an aspiration when I chose the agenda. I hoped to be able to attract people from beyond my network. I assumed that given Boston’s size and industrial base we would get members from varied industries, and I hoped we would get participants from various points of their careers (students to grizzled veterans).
  4. Real passion – people care! To say that folks care about quality and how we build it in our organizations may just be an understatement. Does everyone care? No. Will 500 people show up? No. Which is a good thing because I didn’t get that large of a room
  5. Genuine urgency: This may be the weakest of the criteria for me. But urgency is subjective and I for me as an organizer there is a great deal of urgency. I need to get more people involved and empowered in the division!

25/10 Crowd Sourcing

I think it’s important to generate and sort the ideas for action so participants hopefully leave ready to get things done! 25/10 Crowd Sourcing is an excellent activity designed to spread innovations “out and up” as everyone notices the patterns in what emerges. Fun, fast, and casual, it is a serious and valid way to generate an uncensored set of bold ideas and then to tap the wisdom of the whole group to identify the top ten. May go lower with a smaller group.

Every participant writes on an index card their bold idea and first step. Then people mill around, and pass cards from person to person. “Mill and Pass only. No reading.” When the bell rings, people stop passing cards and pair up to exchange thoughts on the cards in their hands. Then participants individually rate the idea/step on their card with a score of 1 to 5 (1 for low and 5 for high) and write it on the back of the card. Again, we pass the cards around a second time and then “Read and Score”. This is done for a total of five scoring rounds. At the end of cycle five, participants add the five scores on the back of the last card they are holding. Finally, the ideas with the top scores are shared with the whole group.

From this – action plan! Agree on way to keep momentum and away we go!

Other thoughts

A key requirement is to record discussions as they happen. Hopefully, that is the case and we get a nice raw output from this.

I use Session Lab for most of my facilitation planning these days. The site is a wonderful way to quickly find activities and build blocks, and the agendas it spits out are very clean.

Food is so critical.  There will be a good hot lunch. I will also grab breakfast for folks on my way in.

This is designed to be an experiment. I have kept the price low, and then charged it to the Division for ASQ members as part of the member value. I want to do at least one more this year. It is important to experiment with content building and sharing, and this format is designed to draw on the expertise and perspective of the participants. I am thrilled to be doing this and going in I am very hopeful of the outcome. 

Brainstorming usually sinks your ship

If you work in teams, chances are you use brainstorming, gathering face-to-face in groups so that everyone can share ideas. This technique has been around since the late 1930s and many in quality and excellence pursuits view it as an effective technique.

Unfortunately, the science I’ve read is not quite in agreement. A group of four people typically generates approximately half as many ideas as a nominal group of four does. Production blocking, and a few other problems, lead to some key deficiencies in brainstorming:

  •  When group members are waiting for turn-taking, there are high chances that they may forget the ideas that they had in mind, they may focus on remembering those ideas rather than listening, or they may decide their ideas are no longer relevant.
  • The competing demand for coming up with one’s own idea and listening to other’s ideas makes it difficult to build on the ideas of others.
  • As the size of the group increases, the participants might feel less identifiable or accountable which might lead to decreased social loafing or level of motivation.

Overcoming production blocking requires the use of additional tools, such as brainwriting. Brainwriting encompasses the sharing of ideas through pieces of paper – usually having people write their ideas out on post-it notes for example. This technique makes brainstorming effective by overcoming the problem of verbal brainstorming. Though their seems to be some worry here about social cues kicking in, and there may be more benefit in having folks write all their ideas on one piece of paper, or better yet on their own before the meeting.

Brain writing, to be truly effective, requires solid collaborative evaluation process to follow the idea generation phase this is the foundation of decision quality. The research seems to indicate we see results better than the norm with this combination.

This appears to be an area where more research is needed to examine different variations , the boundary conditions for demonstrating the superiority of brainwriting over nominal groups, the optimum size of the group, and the potential of mixing verbal and nonverbal brainstorming. If anyone knows of good studies in this area, please point me to them.

References

  • Coskun, H. (2005). Cognitive stimulation with convergent and divergent thinking exercises in brainwriting: Incubation, sequence priming, and group context. Small Group Research, 36, 466-498. doi:10.1177/1046496405276475
  • Cragan, J. F., Wright, D. W., & Kasch, C. R. (2009). Communication in small groups : theory, process, skills. Boston, MA: Cengage Learning – Academic and Professional Group.
  • West, M. A. (2012). Effective teamwork : practical lessons from organizational research. Wiley-Blackwell.

ASQ Team and Workplace Excellence Unconference

The Team and Workplace Excellence invites you to atted our Unconference on 29-Feb-2020 in Boston, MA.

An unconference is a wonderful way to address a problem by asking people who are passionate about the subject to drive the content, and by flexibly changing the day’s activities based on the interests of the people involved.

We are going to start with a back-of-the napkin exercise to start answering the question “What does Team Excellence look like.” This exercise is just what it sounds like, we will break into teams and write/draw an answer on the back of a napkin.

After this we will role up our sleeves and go from there. The unconference is an experiment, and we expect a small but committed crowd (right now we have about 15 people, if I get 30 I’ll be the happiest of organizers).

An unconference is a great process because everyone who cares about the challenge at hand (team excellence and quality culture) can accept the organizers’ invitation and is included with an equal opportunity to contribute. We are trying to make sure that our participants issues are raised and that there is a sense of responsibility for tacking the issues we care about. The “Law of Two Feet” governs the participation of all attendees in the various sessions: “Go and attend whichever session you want, but if you find yourself in a session where you are not learning or contributing, use your two feet!”

As an experiment, the unconference serves two purposes: 1. Try a slightly different way of working; and, 2. Drive the development of a body of knowledge for the Division and the ASQ.

We will start together in a large circle (or maybe two concentric circles depending on the space). The participants will suggest sessions and then away we go!

We will end the day by a call to action and an agreed upon plan. This will drive a lot of Team and Workplace Excellence activities for the next year.

If the experiment is a success, the Team and Workplace Excellence Forum has funds earmarked to hold 2 more this year. Ideally, I’d like to do at least one in a different region of the country.

The Unconference is free to all ASQ members. There will be a charge for non-ASQ members’ of $15.00 for lunch. This counts as professional development for those with ASQ certifications.

See the my.ASQ event page for details and register here.

Building Experts

Subject matter experts have explicit knowledge from formal education and embedded in reports, manuals, websites, memos, and other corporate documents. But their implicit and tacit knowledge, based on their experience, is perhaps the source of their greatest value — whether the subject-matter expert with decades of experience who is lightning fast with a diagnosis and almost always spot-on or the manager whose team everyone wants to be on because she’s so good at motivating and mentoring.

Experts, no matter the domain, tend to have very similar attributes. Understanding these attributes allows us to start understanding how we build expertise.

DimensionExperts Demonstrate
Cognitive
Critical know-how and “know-what”Managerial, technical, or both; superior, experience-based techniques and processes; extraordinary factual knowledge
System thinkingKnowing interdependencies, anticipating consequences, understanding interactions
JudgementRapid, wise decision making
Context AwarenessAbility to take context into account
Pattern RecognitionSwift recognition of a phenomenon, situation, or process that has been encountered before
Behavioral
Networking (“Known-who”)Building and maintaining an extensive network of professionally important individuals
InterpersonalAbility to deal with individuals, including motivating and leading them; comfort with intellectual disagreement
CommunicationAbility to construct, tailor, and deliver messages through one or more media to build logical and persuasive arguments
Diagnosis and cue seekingAbility to actively identify cues in a situation that would confirm or challenge a familiar pattern; ability to distinguish signal from noise
Physical
SensoryAbility to diagnose, interpret, or predict through appropriate senses
Attributes of an Expert

One of the critical parts of being a subject matter expert is being able to help others absorb knowledge and gain wisdom through learn-by-doing techniques— guided practice, observation, problem solving, and experimentation.

Think of this as an apprenticeship program that provides deliberate practice with expert feedback, which is fundamental to the development of expertise.

Do your organizations have this sort of organized way to train an expert? How does it work?