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

Making Learning a Part of Everyday Work

Cultivating expertise, in short learning, is critical to building a quality culture. Yet, the urgency of work easily trumps learning. It can be difficult to carve out time for learning in the inexorable flow of daily tasks. We are all experienced with the way learning ends up being in the lowest box on the 2×2 Eisenhower matrix, or however you like to prioritize your tasks.

For learning to really happen, it must fit around and align itself to our working days. We need to build our systems so that learning is an inevitable result of doing work. There are also things we as individuals can practice to make learning happen.

What we as individuals can do

Practice mindfulness. As you go about your daily job be present and aware, using it as an opportunity to ability to learn and develop. Don’t just sit in on that audit; notice and learn the auditor’s tactics and techniques as you engage with her. Ask product managers about product features; ask experts about industry trends; ask peers for feedback on your presentation skills. These kinds of inquiries are learning experiences and most peers love to tell you what they know.

Keep a to-learn list. Keep a list of concepts, thoughts, practices, and vocabulary you want to explore and then later later explore them when you have a few moments to reflect. Try to work a few off the list, maybe during your commute or at other times when you have space to reflect.

Build learning into your calendar. Many of us schedule email time, time for project updates, time to do administrative work. Make sure you dedicate time for learning.

Share meaningfully. Share with others, but just don’t spread links. Discuss why you are sharing it, what you learned and why you think it is important. This blog is a good example of that.

What we can build into our systems

Make sure our learning and knowledge management systems are built into everything we do. Make them easy to use. Ensure content is shared internally and leads to continuous improvement.

Ensure learning is valued.

Plan for short-term wins. There is no nirvana, no perfect state. Ensure you have lots of little victories and shareable moments. Plan for this as part of your schedules and cycles.

Learning is a very effective lever for system improvement. At the very least it gives us the power to “add, change, evolve or self-organize system structure” (lever 4) and can also start giving us ways to change the paradigm (lever 2) and eventually even transcend paradigms (lever 1).

Empathy and Feedback as part of Quality Culture

Many of us have had, or given, a talk about how we can learn from children in how to communicate, whether it is being thoughtful in our relationships or learning to adapt and be resilient, or some other point.

Zach Weinersmith, Saturday Morning Breakfast Cereal

What we are really talking about how communicating empathetically is essential, including to building a quality culture and it is a key part of change management.
People need to feel respected and have a sense of self-worth in order to be motivated, confident, innovative, and committed to their work and to appropriately engage in quality culture.

I am not going to pretend to be an expert on empathy. I think it is fair to say that is still (always) one of my key development areas. That said, I think a core skill of any quality leader is that of giving feedback.

People need to feel respected and have a sense of self-worth in order to be motivated, confident, innovative, and committed to their work.

To provide good feedback focus on doing the following:

  • Focus on facts.
  • Respect and support others. Even when people aren’t performing their best, they need to feel your support and to know that they’re valued.
  • Clarify motives. Don’t jump to conclusions. Keep others’ self-esteem in mind, and you’ll be more likely to ask, “What can you tell me about this error?” instead of, “Don’t you care about quality?”

When someone has done a good job, succeeded at a task, or made a contribution, you want to enhance that person’s self-esteem. Some ways to do that are to:

  • Acknowledge good thinking and ideas. Demonstrations of appreciation encourage people to think and contribute, and they support innovation and intellectual risk taking.
  • Recognize accomplishments. People need to hear specifically what they’ve done to contribute to the team’s or organization’s success. This encourages them to sustain or exceed expectations.
  • Express and show confidence. Voicing your trust and then calling on people to show what they can do boosts their confidence and their feelings of self-worth.
  • Be specific and sincere. When you describe in detail what people do well and why it’s effective, they know exactly what you’re recognizing.

Nothing can deflate people’s confidence faster than telling them they’re responsible for something, and then doing it yourself. Conversely, when you provide support without removing responsibility, you build people’s sense of ownership of the task or assignment as well as the confidence that they can accomplish it. When you use this Key Principle, remember to:

  • Help others think and do. Provide your support in two ways: Help others think of ideas, alternatives, and solutions, then support them so that they can execute the plan.
  • Be realistic about what you can do and keep your commitments. Remember that you don’t have to do it all, but be sure to do whatever you agree to.
  • Resist the temptation to take over—keep responsibility where it belongs.

Many quality individuals tend to be action oriented and task driven, so keeping responsibility where it belongs can take resolve, even courage. You might have to overcome the protests of a team member who is reluctant to stretch into new areas or even brave objections from a key manager about your decision to support others rather than take over.

Feedback Conversation Structure

Open

In the OPEN step you ensure that the discussion has a clear purpose and that everyone understands the importance of accomplishing it.

  • Always state purpose and importance clearly in the discussion opening.
  • If you initiate the discussion, explain what you would like to accomplish and why.
  • If someone else is leading the discussion, ask questions if necessary to pinpoint the purpose and importance.
  • Cite how accomplishing the purpose would benefit others in the discussion.
  • Ask if there are any related topics to discuss.

Clarify

There are two types of information to seek and share in this step: facts and figures and issues and concerns. Both are essential to building a complete picture of the situation.

  • Facts and figures are the basic data and background information that people need to understand the situation and make informed decisions.
  • Exploring issues and concerns provides insight into potential barriers to achieving your purpose. It also helps reveal people’s feelings about the situation, which is valid, important information to gather.

Develop

When developing ideas, it’s important to ask questions and include others in the process. Most likely, you’ll have ideas about what to do, and you should share them. However, you should put equal emphasis on seeking others’ ideas. Involving people in thinking about alternative approaches can:

  • Spark their creative energy.
  • Result in more and better ideas than you alone could generate.
  • Build commitment to turning ideas into action.

Agree

It’s important that you and the people involved agree on a plan for following through on the ideas that were developed and for supporting those who will take action. During this step:

  • Specify what will be done, who will do it, and by when.
  • Agree on any follow-up actions needed to track progress in carrying out the plan.
  • Be sure to agree on needed resources or support.

Close

This is the final chance to make sure that everyone is clear on agreements and next steps and committed to following through. Closing discussions involves a summary of actions and agreements as well as a check on the person’s or team’s commitment to carrying them out.