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.

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?

Task Analysis

What is Task Analysis?

A task analysis breaks down a complex task into its components – the steps involved and the knowledge required. To do a task analysis, you observe the work and interview a subject matter expert (SME) or key performer.

What do you want to identify in a task analysis?

  • Why someone would learn the skill
  • Prerequisite skills, knowledge and attitudes
  • Special materials or tools required
  • Warnings of dangers, both overall and at specific points in the process
  • The critical steps (no more than five to seven, otherwise you should split it into another task) and their sequence
  • Whether the sequence is critical or flexible
  • Any other steps necessary to complete the task and their sequence
  • How critical any given substep is
  • Conditions that must be satisfied before going on to the next step
  • Reasons for doing steps at a particular point
  • Signs of success for each step (for confirmations)
  • Signs of failure for each step

What is the process for doing a task analysis?

  1. Review any documentation, manuals or process maps
  2. Observe at least one expert and take notes as you observe
  3. Either slow down experts during the task to ask questions or interview afterward
  4. Identify each step
  5. Document what you saw and what the expert told you, then ask for the SME’s reaction, there will almost always be gaps identified
  6. Expect the process to be iterative

What should you ask the SME?

  • What is the SME doing?
  • Why is it important, or what is the rationale?
  • Why is the SME doing it that way?
  • Is there a warning necessary?
  • How does the SME know what to do next (if there is a choice between two or more actions)?
  • How can the SME tell if a step was done right?
  • How can the SME tell if a step was done wrong or incompletely?
  • How is the sequence critical?
  • What does the SME do that isn’t documented?

While often viewed from the training perspective, task analysis is a core quality tool that is utilized in procedure writing, automation, user interface development, problem solving and so much more.

ASQ Lean and Six Sigma Conference – Speaker

I will be presenting at the ASQ Lean and Six Sigma Conference on March 5, 2019 on the topic “Training as Part of Lean Change Management.”

If you plan on being at the conference, let me know. I always enjoy sitting down with colleagues and chatting.

This topic unites three of my passions: change management, knowledge management and continuous improvements. 

One of the key parts of any change stemming from a project is preparing people to actually do the work effectively. Every change needs to train and building valid and reliable training at the right level for the change is critical.

Training is valid when it is tied to the requirements of the job – the objectives; and when it includes evaluations that are linked to the skills and knowledge started in the objectives. Reliability means that the training clearly differentiates between those who can perform the task and those who cannot.

In this session we will take a risk based training approach to the best outcome for training. The following criteria will be examined and a tool provided for decision making:

  • Is a change in knowledge or skills needed to execute the changed process?
  • Is the process or change complex? Are there multiple changes?
  • Criticality of Process and risk of performance error? What is the difficulty in detecting errors?
  • What is the identified audience (e.g., location,size, department, single site vs. multiple sites)?
  • Is the goal to change workers conditioned behavior?

Armed with these criteria, participants will then be exposed to specific training tools to enable quick adoption of the training:reader-doer, pre-job briefings, and structured discussions. Advantages of each method, as well as common mistakes will be evaluated.

Knowledge management as a key enabler to lean improvements will be examined. Participants will gain an understanding of how to draw from their organizations formal and informal knowledge management systems, and gain an understanding a tool to ensure results of a lean project feedback into the knowledge management system.

Participants will leave this training with the ability to execute decision making around providing successful training for their lean projects and ensuring that this deepens their organization’s knowledge and the ability to apply that knowledge in the future.

Change Management of multi-site implementations

A colleague asks in response to my post Group change controls:

… deploying a Learning + documentation system … all around the word [as a global deployment]  … do we I initiate a GLOBAL CC or does each site created a local CC.

The answer is usually, in my experience, both.

Change management is about process, organization, technology and people. Any change control needs to capture the actions necessary to successful implement the change.

so at implementation I would do two sets of changes. A global to capture all the global level changes and to implement the new (hopefully) harmonized system And then a local change control at each site to capture all the site impact.

System Element Global Local
Process Introduce the new global process

Update all global standards, procedures, etc

How will local procedures change? How will local system interactions change – clean up all the local procedures to ensure the point to the new global procedures and are harmonized as necessary.
Technology Computer system validation

Global interfaces

Global migration strategy

Local interfaces (if any) and configurations

Are local technologies being replaced? Plan for decommissioning.

Local migration (tactical)

People What do people do on the global level?

How will people interact within the system in the future?

Global training

What will be different for people at each individual site?

Localized training

Organization Will there be new organizational structures in place? Is this system being run out of a global group? How will communication be run.

System governance and change management

Site organization changes

How will different organizations and sub organizations adopt, adapt and work with the system

If you just have a global change control you are at real risk of missing a ton of local uniqueness and leaving in place a bunch of old ways of thinking and doing things.

If you just do local change controls you will be at risk of not seeing the big picture and getting the full benefits of harmonization. You also will probably have way too many change controls that regurgitate the same content, and then are at risk of divergence – a compliance nightmare.

This structure allows you better capture the diversity of perspectives at the sites. A global change control tends to be dominated by the folks at each site who own the system (all your documents and training folks in this example), while a site change will hopefully include other functions, such as engineering and operations. Trust me, they will have all sorts of impact.

This structure also allows you to have rolling implementations. The global implements when the technology is validated and the core processes are effective. each site then can implement based on their site deliverables. useful when deploying a document management system and you have a lot of migration.

Multisite changes

As part of the deployment make sure to think through matters of governance, especially change management. Once deployed it is easy to imagine many changes just needing a central change control. But be sure to have thought through the criteria that will require site change controls – such as impact other interrelated systems, site validation or different implementation dates.

I’ve done a lot of changes and a lot of deployment of systems. This structure has always worked well. I’ve never done just a global and been happy with the final results, they always leave too much unchanged elements behind that come back to haunt you. In the last year I’ve done 2 major changes to great success with this model, and seen one where the decision not to use this model has left us with lots of little messes to clean up.

As a final comment, keep the questions coming and I would love to hear other folks perspectives on these matters. I’m perpetually learning and I know there are lots of permutations to explore.