CVs and JDs and Training Plans

In the post “HR and Quality, joined at the hip” I covered some of the regulations that set the expectations in the pharmaceutical and medical device industries that employees have the appropriate education, experience and training to do their jobs. What is often called the personnel qualification triangle.

A job description is a written document that outlines the duties, responsibilities, contributions, behaviors, outcomes and required qualifications for a specific job in an organization. A good job description is a specification that results from a detailed job analysis. It is used in hiring and performance evaluation. It is also the starting point for determining a good GxP training plan.

In order to providing the specific knowledge, skills, abilities and behaviors that need to be addressed for each employee, the job description needs to specifically call out the roles in the processes an employee will play. Instead of providing broad statements like “participate in CAPAs” or “Manufacture product” it should be more specific such as “create and project manage CAPAs” or “Perform visual inspection.”

I challenge everyone to think broadly about the job description as a tool to drive excellence. Utilized throughout the life of employment, a job description is a powerful tool that can aid managers. Managers have a road map that can help them with their duties of planning, leading, organizing, controlling and staffing. With a road map, the complexities of the organization become easier.

The curricula vitae provides evidence that the employee is fit-for-purpose to the job description. The curricula vitae shows education and experience that demonstrates the possession of knowledge, skills, abilities and behaviors.

The training plan then lays out what the employee needs to bit fit-for-use, to be able to do all the roles in the job description. It includes all the process and role specific training, as well as filling in any gaps that might exist on the curricula vitae.

The Personnel Qualification Triangle of Education, Experience and Training

It is important to note that this may not be a fine equilateral triangle. Experience, for example, can often, but not always make up for education.

Failure Points in the Personnel Qualification Triangle

  • Position and experience descriptions on CVs do not match the corresponding job description. This red flag stems from a lack of coordination between the curricula vitae and job description, which can be particularly concerning when an employee has a job description that requires very specific technical knowledge or oversees other seemingly unrelated areas that their experience would indicate.
  • Employee positions current position is not included in curricula vitae. The curricula vitae should always include the current position. While not a deal breaker, this is perhaps the easiest way to see large gaps in the cv, especially if the employee moves around or up in the same organization.
  • Curricula vitae do not reflect the level of experience expected given the employee’s job title.
  • The roles and responsibilities documented in in the job descriptions do not correspond with those included in SOPs. A reviewer should be able to go from a process to anyone engaged in the process and be able to see the work the individual does reflected.
  • Job titles match. Curricula vitae, job descriptions and what an individual is listed as on an organizational chart need to all match. I usually go as far to check someone’s business card before they go into meet with an inspector or external auditor.

What prevents us from improving systems?

Improvement is a process and sometimes it can feel like it is a one-step-forward-two-steps-back sort of shuffle. And just like any dance, knowing the steps to avoid can be critical. Here are some important ones to consider. In many ways they can be considered an onion, we systematically can address a problem layer and then work our way to the next.

Human-error-as-cause

The vague, ambiguous and poorly defined bucket concept called human error is just a mess. Human error is never the root cause; it is a category, an output that needs to be understood. Why did the human error occur? Was it because the technology was difficult to use or that the procedure was confusing? Those answers are things that are “actionable”—you can address them with a corrective action.

The only action you can take when you say “human error” is to get rid of the people. As an explanation the concept it widely misused and abused. 

Human performance instead of human error
AttributePerson ApproachSystem Approach
FocusErrors and violationsHumans are fallible; errors are to be expected
Presumed CauseForgetfulness, inattention, carelessness, negligence“Upstream” failures, error traps; organizational failures that contribute to these
Countermeasure to applyFear, more/longer procedures, retraining, disciplinary measures, shamingEstablish system defenses and barriers
Options to avoid human error

Human error has been a focus for a long time, and many companies have been building programmatic approaches to avoiding this pitfall. But we still have others to grapple with.

Causal Chains

We like to build our domino cascades that imply a linear ordering of cause-and-effect – look no further than the ubiquitous presence of the 5-Whys. Causal chains force people to think of complex systems by reducing them when we often need to grapple with systems for their tendency towards non-linearity, temporariness of influence, and emergence.

This is where taking risk into consideration and having robust problem-solving with adaptive techniques is critical. Approach everything like a simple problem and nothing will ever get fixed. Similarly, if every problem is considered to need a full-on approach you are paralyzed. As we mature we need to have the mindset of types of problems and the ability to easily differentiate and move between them.

Root cause(s)

We remove human error, stop overly relying on causal chains – the next layer of the onion is to take a hard look at the concept of a root cause. The idea of a root cause “that, if removed, prevents recurrence” is pretty nonsensical. Novice practitioners of root cause analysis usually go right to the problem when they ask “How do I know I reached the root cause.” To which the oft-used stopping point “that management can control” is quite frankly fairly absurd.  The concept encourages the idea of a single root cause, ignoring multiple, jointly necessary, contributory causes let alone causal loops, emergent, synergistic or holistic effects. The idea of a root cause is just an efficiency-thoroughness trade-off, and we are better off understanding that and applying risk thinking to deciding between efficiency and resource constraints.

In conclusion

Our problem solving needs to strive to drive out monolithic explanations, which act as proxies for real understanding, in the form of big ideas wrapped in simple labels. The labels are ill-defined and come in and out of fashion – poor/lack of quality culture, lack of process, human error – that tend to give some reassurance and allow the problem to be passed on and ‘managed’, for instance via training or “transformations”. And yes, maybe there is some irony in that I tend to think of the problems of problem solving in light of these ways of problem solving.

Pandemics and the failure to think systematically

As it turns out, the reality-based, science-friendly communities and information sources many of us depend on also largely failed. We had time to prepare for this pandemic at the state, local, and household level, even if the government was terribly lagging, but we squandered it because of widespread asystemic thinking: the inability to think about complex systems and their dynamics. We faltered because of our failure to consider risk in its full context, especially when dealing with coupled risk—when multiple things can go wrong together. We were hampered by our inability to think about second- and third-order effects and by our susceptibility to scientism—the false comfort of assuming that numbers and percentages give us a solid empirical basis. We failed to understand that complex systems defy simplistic reductionism.

Zeynep Tufekci, “What Really Doomed Americas Coronovirus Response” published 24-Mar-2020 in the Atlantic

On point analysis. Hits many of the themes of this blog, including system thinking, complexity and risk and makes some excellent points that all of us in quality should be thinking deeply upon.

COVID-19 is not a black swan. Pandemics like this have been well predicted. This event is a different set of failures, that on a hopefully smaller scale most of us are unfortunately familiar with in our organizations.

I certainly didn’t break out of the mainstream narrative. I traveled in February, went to a conference and then held a small event on the 29th.

The article stresses the importance of considering the trade-offs between resilience, efficiency, and redundancy within the system, and how the second- and third-order impacts can reverberate. It’s well worth reading for the analysis of the growth of COVID-19, and more importantly our reaction to it, from a systems perspective.

Procedure Lifecycle

We write and use procedures to help the user complete the task successfully and avoid undesired outcomes. Well-written procedures are an integral part of any organization for operation, managing risks, and continuous improvement. Effective procedures are important for the transfer of knowledge from the engineers/architects of the system to the users of the system.

Good procedures, and we are not talking format so this can be paper documents to a mixed reality guide, provide these four categories of information:

  1. Goal: The goal presented to the user as a state to be realized. This can be an end state or an intermediate state of the overall system.
  2. Prerequisites: The condition for moving toward the desired state or goal. These are the conditions that must be satisfied so that the user can achieve the goal.
  3. Actions and reactions: These states are reached through actions of the user and the reactions of the system. They may have milestones or sub-goals. It involves the description of (a series of) action steps.
  4. Unwanted: These are the states to be avoided (e.g., errors, malfunctions, injuries). It provides guidelines on what to avoid for successful and safe execution of procedure and may include warning, caution, or instruction for solving a potential problem.

Procedures have a lifecycle through which they are developed, administered, used, reviewed, and updated. In the post “Document Management” I discussed the document management lifecycle.

I want to focus specifically on procedures by covering five distinct phases: procedure plan, design and development, procedure authorization, procedure administration, procedure implementation and use, and procedure review and maintenance.

Outlines the 5 phases of a procedure lifecycle
Lifecycle of a procedure
PhaseIncludesDocument Management Steps
Procedure plan, design and developmentIdentifying whether a procedure is necessary; collecting required information; producing instructions and information on the work, regulatory compliance, process and personnel safety; a walkthrough to ensure quality and potential compliance of the procedure“New SOP is needed”   Drafting    
Procedure AuthorizationProcedure review; publishing the final document; revision control; the approval process.Review Approval
Procedure AdministrationManaging procedure repository, control, and deployment; identifying administers how, when, and to whom procedures are to be delivered. 
Procedure Implementation and UseProcedure is used in operations 
Procedure review and maintenancePeriodic review of documents, as well as updates from the CAPA and Change Management processesPeriodic Review

References

  • Procedure Professionals Association (PPA), 2016. Procedure Process Description. (PPA AP-907-001)
  • Van der Meij, H., Gellevij, M., 2004. The four components of a procedure. IEEE Trans. Prof. Commun. 47 (1), 5–14