“There’s a tension because especially in very hierarchical systems they’re quite worried about being and looking competent and at the same time their real performance, their real safety, their longer-term survivability is based on the ability to keep getting better and to be almost unnaturally observant and attentive to failures, little mishaps in processes a weakness. So, for high-risk organizations, they need to be just unnaturally attentive to the things that go wrong but that can feel very much at odds with looking good and with looking like performance. So, one could actually say that the real tensions between the appearance of performance and learning that real performance and particularly overtime, is in fact dependent on about learning.“
Psychological safety enables individuals to behave authentically, take risks and express themselves candidly. In the workplace, psychological safety captures how comfortable employees feel as team members. Timothy Clark gives four elements of psychological safety:
- Being included
- Feeling safe to experiment
- Challenging the status quo
This is done through four pillars:
- Capability – colleagues’ competence, knowledge and skills
- Consistency – how dependable colleagues are when making commitments
- Caring – connections to colleagues that are based on genuine warmth and emotional support
- Candor – communication with honesty and integrity
Psychological safety, Reflexivity and a Learning Culture
Reflexivity is the extent employees reflect upon the work tasks they have completed and identify ways of improving performance – it is the information-processing activity. Using reflexivity, employees develop a better sense of what is done, why and how, and can adjust their behaviors and actions accordingly. Reflexivity is a powerful process that can drive performance in a learning culture that requires psychological safety to flourish. When employees reflect upon their work tasks, they need to have a deeper and better understanding of what they have done, what was done well and not as well, why they engaged in these behaviors, and changes and adaptations needed to result in better performance. People are not likely to engage in reflexivity unless they feel psychologically safe to take interpersonal risks, speak up, and admit failures without feeling uncomfortable or fearful of status and image loss.
Clark, T.R. 2020. The 4 Stages of Psychological Safety. Oakland, CA: Barrett-Koehler
Edmondson, A. 2018. The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation and Growth. Hoboken, NJ: John Wiley and Sons
West, M.A. 1996. Reflexivity and work group effectiveness: A conceptual integration. In M.A. West (Ed.), Handbook of work group psychology. Chichester, UK: Wiley.
Zak, P.J. 2018. “The Neuroscience of High-Trust Organizations.” Consulting Psychology Journal: Practice and Research 70(1): 45-48
The biggest thing I am working on is situational humility. How do I successfully balance the subject matter expertise my organization needs with the humility to truly lead? It is clear that such humility is critical to building psychological safety, and psychological safety is critical to building innovative teams.
For most of my career I’ve been prized for my subject matter expertise, but there are huge limits, no one can know everything, so I am cultivating the following behaviors in my practices.
|To build Humility do this||Which means||And I do this|
|Know what you don’t know||Resist “master of the universe” impulses. You may yourself excel in an area, but as a leader you are, by definition, a generalist. Rely on those who have relevant qualification and expertise. Know when to defer and delegate.||I have a list of key topics that are both in my space and overlap and individuals who involving in the discussion is critical.|
I’ve created a “swear jar” for every time I say something like “I have an answer” and at this rate I’ll be taking a lot of people out for drinks by the time this pandemic is over. It is all IOUs right now because I don’t remember the last time I used cash and I don’t think I’ve seen a dollar bill in 11 months.
|Resist falling for your own publicity||We all put the best spin on our success — and then conveniently forget that the reality wasn’t as flawless.||This is an interesting one for me. Having joined a new company 10 months ago it has been important to avoid the spin on my joining, and to not exacerbate it.|
I’ve taken to keeping a list of problems and who is the right people who are not me that can solve them.
|Never underestimate others||The world is filled with other hard-working, knowledgable, and creative professionals||I purposely look for opportunities to meet with folks at all levels and ask them to collaborate.|
|Embrace and promote a spirit of service||Focus on finding ways to help others to succeed||I’m all about the development. Crucial for me here is stepping back and letting others lead, even if its more work for me as I spend more time coaching and mentoring than would actually take to do the job. But lets be honest, can’t and shouldn’t do anything.|
|Listen, even (no, especially) to the weird ideas||Only when you are not convinced that your idea is or will be better than someone else’s do you really open your ears to what they are saying. But there is ample evidence that you should: the most imaginative and valuable ideas tend to come from left field, from some associate who seems a little offbeat, and may not hold an exalted position in the organization.||I love the weird, though maybe most when they are my weird ideas. Been working to strengthen idea management as a concept and practice in my organization.|
|Be passionately curious||Constantly welcome and seek out new knowledge, and insist on curiosity from those around you. Research has found linkages between curiosity and many positive leadership attributes (including emotional and social intelligence). Take it from Einstein. “I have no special talent,” he claimed. “I am only passionately curious.”||I’m a voracious reading machine, its always been a central skill.|
How I am trying to teach others to be curious and turn it to their advantage.
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.
|ICH E6 R2, 2.8||Each 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.02.006||Every 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 2.1||All parts of the Pharmaceutical Quality system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities.|
|WHO Annex 3-GMP||9.2 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 7.2||Key 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/541760/2011||Achieving 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.|
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.
Looking at the 2020 FDA 483 data we can see that these regulations are a concern throughout organizations.
|Citation Program Area||Reference Number||Short Description||Long Description||Frequency|
|Bioresearch Monitoring||21 CFR 58.29(a)||Personnel: education, training, experience||Not 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|
|Devices||21 CFR 820.25(b)||Training – Lack of or inadequate procedures||Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***||30|
|Devices||21 CFR 820.25(b)||Training records||Personnel training is not documented. Specifically, ***||18|
|Drugs||21 CFR 211.25(a)||Training–operations, GMPs, written procedures||Employees 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|
|Drugs||21 CFR 211.25(a)||Training , Education , Experience overall||Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***||14|
|Drugs||21 CFR 211.25(a)||GMP Training Frequency||GMP 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|
|Drugs||21 CFR 211.25(b)||Supervisor Training/Education/Experience||Individuals 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|
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.