In this version, the responsible Task Force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), mainly made additions and updates in chapters 11 – Laboratory Controls, 15 – Complaints and Recalls, and in section 16 – Contract Manufacturers (incl. Laboratories).
The addition in section 11.11 for “Approval/rejection of materials” is pretty striaghtforward – have an SOP.
The changes in section 15 for recalls is pretty cosmetic.
I would re-read section 16 on contract manufacturers. Not much substantial here, but the rewrite makes it a good time to ensure compliance.
Interesting perspective on adapting what makes us successful as problem solvers as we move into more senior leadership positions. Resonates very well with some of my own challenges, so I stronly recommend listening to this episode.
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.