Teaching Quality People to Listen

Been thinking a lot on what a training program around teaching people to listen and not to talk might look like and how it fits into a development program for quality professionals.

People in quality think a lot on how to make a reasoned argument, a good decision, to provide guidance, get their point across in meetings, persuade or coerce people to follow standards. This is understandable, but it has a cost. There is a fair amount of research out there that indicates that all too often when others are talking, we are getting ready to speak instead of listening.

I think we fail to listen because we are anxious about our own performance, concerned about being viewed as an expert, convinced that our ideas are better than others, comfortable in our expertise, or probably all of the above. As a result we get into conflicts that could be avoided, miss opportunities to advance the conversation, alienate people and diminish our teams’ effectiveness.

When we really listen we create the spaces to make quality decisions. Listening can be improved by these practices:

Ask expansive questions. Stay curious, build on other’s ideas are mantras I think most of us are familiar with. Suppress the urge to interrupt or dominate a conversation and concentrate on the implications of other people’s words. It is very easy for a quality professional to instantly leap to solving the problem, and we need to be able to give space. Focus on open-ended “what” and “how” questions, which encourage people to provide more information, reflect on the situation and feel more heard. Avoid yes-and-no questions which can kill dialogue.

Engage in “self-checks”. Be aware of one’s own tendencies and prepare with ways to identify they are happening and head them off. Doing this will surprisingly allow you to focus on the listener and not yourself moving beyond the words that are being said and being able to take in the speaker’s tone, body language, emotions and perspective, and the energy in the conversation.

Become comfortable with silence. This means communicating attentiveness and respect while you are silent.

Listening needs to be part of our core competencies, and unless we work on it, we don’t get better.

Decision Quality helps overcome bad outcomes

We gather for a meeting, usually around a table, place our collective attention on the problem, and let, most likely let our automatic processes take over. But, all too often, this turns out to be a mistake. From this stems poor meetings, bad decisions, and a general feeling of malaise that we are wasting time.

Problem-solving has stages, it is a process, and in order for groups to collaborate effectively and avoid talking past one another, members must simultaneously occupy the same problem-solving stage. Clear communication is critical here and it is important for the team to understand what. Our meetings need to be methodical.

In a methodical meeting, for each issue that needs to be discussed, members deliberately and explicitly choose just one problem-solving stage to complete.

To convert an intuitive meeting into a methodical one take your meeting agenda, and to the right of each agenda item, write down a problem-solving stage that will help move you closer to a solution, as well as the corresponding measurable outcome for that stage. Then, during that part of the meeting, focus only on achieving that outcome. Once you do, move on.

A Template for Conducting a Methodical Meeting

Pair each agenda item with a problem solving stage and a measurable outcome.

Agenda ItemProblem Solving StageMeasurable Outcome
Select a venue for the offsiteDevelop alternativesList of potential venues
Discuss ERP usage problemsFrameProblem statement
Implement new batch record strategyPlan for ImplementationList of actions / owners / due dates
Review proposed projectsEvaluate AlternativesList of strengths and weaknesses
Choose a vendorMake DecisionWritten decision

If you don’t know which problem-solving stage to choose, consider the following:

Do you genuinely understand the problem you’re trying to solve? If you can’t clearly articulate the problem to someone else, chances are you don’t understand it as well as you might think. If that’s the case, before you start generating solutions, consider dedicating this part of the meeting to framing and ending it with a succinctly written problem statement.

Do you have an ample list of potential solutions? If the group understands the problem, but hasn’t yet produced a set of potential solutions, that’s the next order of business. Concentrate on generating as many quality options as possible (set the alternatives).

Do you know the strengths and weaknesses of the various alternatives? Suppose you have already generated potential solutions. If so, this time will be best spent letting the group evaluate them. Free attendees from the obligation of reaching a final decision—for which they may not yet be ready—and let them focus exclusively on developing a list of pros and cons for the various alternatives.

Has the group already spent time debating various alternatives? If the answer is yes, use this part of the meeting to do the often difficult work of choosing. Make sure, of course, that the final choice is in writing.

Has a decision been made? Then focus on developing an implementation plan. If you’re able to leave the conversation with a comprehensive list of actions, assigned owners, and due dates, you can celebrate a remarkably profitable outcome.

Leverage the CPGP for Quality Maturity

The ASQ’s Certified Pharmaceutical GMP Professional Certification is under-valued. The ASQ really needs to step up and place itself in the forefront of quality culture and maturity, utilizing this certification, as a center-piece. I don’t think there is really a comparable certification on the market and I am continually puzzled why there has not been more adoption.

Let’s break down the ten-points in the St Gallen’s FDA Quality Metrics project and how they link to the body of knowledge behind the CPGP.

Optimized set-up and cleaning procedures are documented as best practice process and rolled out throughout the whole plant.

Cleaning is pretty strong within section IV, Infrastructure: Facilities, Utilities, Equipment, starting with C. Equipment which includes:

  • Equipment layout. Determine the layout of equipment to minimize the risk of errors, to facilitate effective cleaning and maintenance, and to avoid contamination or any other undesired effect on product quality. (Apply)
  • Equipment cleaning and maintenance. Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply)
  • Equipment cleaning validation or verification. Evaluate the need and methodology for product-contact cleaning validation and/or verification. (Evaluate)
  • Equipment change control. Verify that change control has maintained the qualified state of equipment. (Apply)

And section F, General Cleaning, Sanitization, and Sterilization Systems

  • Cleaning procedures. Review cleaning procedures in accordance with cleaning validation, whenever validation is required and performed. (Apply)
  • Sanitization procedures. Review sanitization procedures for facilities and equipment, and ensure all are in accordance with any required validation studies, including details on cleaning schedules, methods, equipment, materials, sanitizers, disinfectants, sporicides, and sterilants. (Apply)
  • Pest control. Review and verify that a pest control program is in place and that it uses authorized rodenticides, insecticides, fungicides, fumigating agents, and appropriate traps for pest elimination. (Apply

A large percentage of equipment on the shop floor is currently under statistical process control.

Section VIII. Product Development and Technology Transfer, is strong here, though I recommend that section IV, Infrastructure: Facilities, Utilities, Equipment have material added here.

For root cause analysis, the firm has standardized tools to get a deeper understanding of the influencing factors for problems.

Section II, Quality Systems. The ASQ is strong in root cause analysis, and this is one of those areas where thinking of the CPGP as a industry specific to add to a problem solving certification pathway. Subsection F. “Investigations and Corrective and Preventive Action (CAPA)” covers this well with:

  • Trigger events. Identify events that require: investigation, root cause analysis, and impact assessment both directly and indirectly related to the event. (Evaluate)
  • Response actions. Define immediate action, corrective action, preventive action, management responsibility, and methods of implementing them. (Evaluate)
  • CAPA feedback and trending. Describe how CAPA trending is used to modify appropriate quality system elements. (Create)

Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives and the site has a clear focus.

Operational controls and monitoring is throughout the CPGP. This is also a great tie-in with the CMQ/OE.

Manufacturers have joint improvement programs with suppliers to increase performance.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.

All potential bottleneck machines are identified and supplied with additional spare parts.

Section 4, C 1 Equipment planning which covers “Equipment planning Review equipment location, design, construction, installation, and maintenance based on the operations to be conducted. (Apply)” and 3 Equipment cleaning and planning “Review procedures and schedules for equipment cleaning, maintenance, and, where necessary, sanitization to ensure that they meet requirements. (Apply) “

For product and process transfers between different units or sites,standardized procedures exist that ensure a fast, stable and compliant knowledge transfer.

Section VII Product Development and Technology Transfer covers this very thoroughly.

Charts showing the current performance status such as current scrap rates and current up times are posted on the shop floor and visible for everyone.

Discussed throughout the body of knowledge is operational controls and failure rates.

The firm regularly surveys customers’ requirements.

Not explicit in the body of knowledge. Much stronger in other certifications, such as CMQ/OE. Probably a good area to get added.

The firm ranks its suppliers and conducts supplier qualifications and audits.

Section 2, K Supplier and Contractor Quality Management breaks this nicely down into Supplier Quality Systems, Supplier Controls and Supplier Evaluation.

Competencies in Quality

Competence is the set of demonstrable characteristics and skills that enable, and improve the efficiency of, performance of a job. There are a ton of different models out there, but I like to think in terms of three or four different kinds of competences: professional and methodological skills; social competence; and self-competence which includes personal and activity- and implementation-oriented skills. Another great way to look at these are competencies for inter-personal (maps to social competence), intrapersonal (maps to self-competence), and cognitive (maps to professional and methodological skills).

The ongoing digital transformation (Industry 4.0) leads to changing competence requirements which means new ways of life-long teaching and learning are necessary in order to keep up.

We can look at the 4 competencies across three different categories: Human, Organization and Technology:

  Human Organization Technology
Professional & methodological expertise
(Cognitive)
System thinking
Process thinking
Results oriented work
Complexity management
Business thinking
Problem solving
Sensitization ergonomics
Structured, analytical thinking
Change management
Qualification/further education
Agile methods/tools
Lean Enterprise
Client orientation
Workplace design
Soft/hardware understanding
Cyber-physical system understanding
Usability
Human-machine interfaces
Social Competence
(Inter-personal)
Inter-disciplinary thinking
Managerial competence
Ability to work as a team
Conflict management
Communication
Empathy
Employee satisfaction
Human centering
Social networking  
Self-Competence
(Intrapersonal)
Lifelong learning
Personal initiative
Innovativeness
Independent work
Sense of responsibility
Readiness for change
Process orientation  

When it comes to the professional competencies there is a large spread depending on what our industries requires. As a pharmaceutical quality professional I have different professional expertise than a colleague in the construction industry. What we do have in common is the methodological expertise I listed above.

Understanding competencies is important, it allows us to determine what skills are critical, to mentor and develop our people. It also helps when you are thinking in terms of body of knowledge, and just want communities of practice should be focusing on.

Situational Awareness and Expertise

One of the key aspects of being an expert is the capacity to apply situational awareness: the perception of relevant information, comprehension of their meaning and the projection to future events.

Developing this situational awareness is a critical part of problem-solving and we can map the 4Cs of trouble-shooting onto these three elements.

Perception

The ability to perceive important information is a critical first step to being able to problem-solve, and one that takes time to develop especially in the highly complex and demanding environments most of us operate in. Knowing which information is important and have an understanding of the many subtle cues to evaluate is one of the hallmarks of an expert. But even for experts it can be difficult, which is why building perceptual cues in our checklists, procedures and such is important.

Comprehension

From perception we can draw meaning and significance, allowing the expert to combine, interpret, store and retain information. Integrating multiple pieces of information to arrive at a determination of relevance.

Projection

Experts are able to project from current events to anticipate future events and their implications.

Model of situation awareness in dynamic decision making (Endsley, 1995)

Further Reading