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.
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.
Take responsibility. Say, “I was wrong.” (Don’t say “mistakes were made” or “it didn’t turn out the way I had anticipated” or any other version that deflects or minimizes your personal contribution). Offer a brief explanation, but do not make excuses. Acknowledge that your error had a negative impact on others, and be willing to really listen, without defensiveness, to others’ recounting of that impact. Do not interrupt. Apologize.
Address what you need to do right now. Taking responsibility is critical, as is taking action. This is core to crisis communication, even if your mistake doesn’t constitute a major crisis. Tell others what you are doing right now to remedy the mistake, and distinguish between the parts that can be fixed, and those that can’t. Include what you are doing to address the substantive impact (money, time, processes, etc.) and well as the relational impact (feelings, reputation, trust, etc.) of having been wrong. Be open to feedback about what you’re doing. Over-communicate your plans.
Share what you will do differently next time. Being wrong is messy. Being wrong without self-reflection is irresponsible, even if you hate self-reflection. Take some time to think about what your contribution was to this situation, and identify how others contributed as well. (Try to stay away from using words like “fault” or “blame” — which tend to put people on the defensive.) Then tell those impacted by your error what you’ve learned about yourself, and what you’re going to do differently in the future. For example, you might recognize that you tend to dismiss the input of someone you don’t see eye-to-eye with, and that in the future, you’re going to actively engage her, and consider her perspective. Ask for help where you need it. And ask others to give you frequent feedback down the road on the commitments you’re making.
Someday these reports won’t take a year to write. If I took a year writing my annual reports I would receive an inspection finding from the MHRA.
There is no surprise that the five critical observations are all from risk management. Risk management is also the largest source of major findings, with quality management a close second with a lot of growth.
There are a lot of observations around the smooth and effective running of the CAPA program; a fair amount on PSMF management; and a handful on procedure, training and oversight.
Looking at the nine major observations due to deficiencies in the management of CAPA, the MHRA reports these problems:
Delays to CAPA development
CAPA that did not address the root cause and impact analysis for the identified noncompliance
Open CAPA which were significantly past their due date
CAPA raised from a previous critical finding raised at an earlier MHRA inspection had not been addressed
I’m going to go out on a limb here and say some of these stem from companies thinking non-GMP CAPAs do not require the same level of control and scrutiny. Root Cause Analysis and a good CAPA program are fundamental, no matter where you fall on (or out of) the pharmaceutical regulatory spectrum.
PIC/S recently updated an Aide Mémoire on inspections of biotech manufacturers in January. The aim of this AiM is to harmonize GMP inspections in biotechnological and biological facilities and to ensure their quality. There wasn’t much new in this version, the revision history says “Minor edits to update cross-references to PIC/S GMP Guide (PE 009-14),” but this is a good time to review the document.
Many of the influencing tactics require you to have informal power. It is a good idea to understand what your major forms of informal power are, so here’s an evaluation tool.
Step 1: List your top 10 contacts that enable you to get work done. These contacts can be either internal or external to your organization.
Step 2: For each contact, assign a score from 1 to 10 indicating how much you depend on them. If a contact provides a lot of value and is also difficult to replace, assign a high score. Think broadly about the value your contacts offer. This includes career advice, emotional backing, support with daily activities, information, and access to resources or stakeholders.
Step 3: Do the same in reverse. Assign a score to yourself from others’ perspectives. Approximate how much value you offer your contacts and how difficult it would be to replace you. Be honest.
Next, look for red flags which could indicate that you lack informal power.
Do all of your contacts work in one team, function, product unit, or office building? This could indicate a limited ability to generate value beyond the basic requirements of your job description.
Do your contacts provide you with more value than you return? Such relationships are difficult to sustain in the long run. Asymmetries in dependence indicate others hold the power in a relationship.
Is all of the value you give or receive concentrated in a couple of contacts? You could be vulnerable if you lose these contacts or your relationship changes.
Once you understand where your informal power lies, figure out how you can improve.
To address the unfavorable power scores, earn relationships by delivering value to your contacts. Ask yourself: what value can you deliver to them? One way is to develop and continuously improve upon a skill set that leads others to value your contributions. Then proactively use your skills to help others, well beyond the demands of your formal role. You don’t want to be the expert whom nobody knows.
Let your job help you. Manage your job description so that you can contribute to the workflows of multiple functions inside the organization as well as customers, outside partners, or regulators. Volunteer for cross-functional initiatives. View lateral transfers as a move up. By positioning yourself at the intersection of workflows, you position yourself to meet, learn from, and deliver value to a variety of diverse groups in the organization.
Get to know your stakeholders and collaborators better as individuals. You may be surprised how something that is rather easy for you to do carries significant value for them. Sometimes we freeze because we believe that we have to offer really significant contributions or do massive favors for others. Knowing others well can present us with helpful alternatives.
Outside of work, join social and professional ones. Shared activities have an underestimated impact on expanding our networks.
Your value is never solely defined by your ability to perform a formal organizational role. By creating value for diverse stakeholders and making yourself irreplaceable, you open possibilities for yourself within the organization and beyond. And, by doing so, you add value to your company.