Competence is a combination of Capability and Skill. If I do not have the capability for the work, no amount of developmental training will be helpful. And, I don’t have the skill, you will never see my capability. Competence is a combination of both.
Interest or passion for the work will influence the amount of time for practice. The more interested I am, the more time I will spend in practice. And if I don’t practice a skill, the skill goes away, and competence diminishes.
There is also a set of required behaviors. Practice arrives with many qualities, frequency of practice, duration of practice, depth of practice, and accuracy of practice. Accuracy of practice relates to required behaviors. Practice doesn’t make perfect, only perfect practice makes perfect.
W. Edwards Deming’s substantive influence upon management thinking and practice is evidenced by the number of organizations that have worked to implement his key points, the abundance of books and papers related to his ideas, and the impact of his ideas on the practice of business today. While I’m not a fan of the term Quality Guru, it is hard to miss his impact.
Deming’s main concepts can be summarized as:
Visionary Leadership: The ability of management to establish, practice, and lead a long-term vision for the organization, driven by changing customer requirements, as opposed to an internal management control role.
Internal and External Cooperation: The propensity of the organization to engage in non-competitive activities internally among employees and externally with respect to suppliers.
Learning: The organizational capability to recognize and nurture the development of its skills, abilities, and knowledge base.
Process Management: The set of methodological and behavioral practices emphasizing the management of process, or means of actions, rather than results.
Continuous Improvement: The propensity of the organization to pursue incremental and innovative improvements to processes, products, and services.
Employee Involvement: The degree to which employees of an organization feel that the organization continually satisfies their needs.
Customer Satisfaction: The degree to which an organization’s customers continually perceive that their needs are being met by the organization’s products and services.
Summarizing the System of Profound Knowledge
Almost thirty years after the publication of The New Economics for Industry, Government, Education and we are still striving to realize these. They are still as aspirational and, for many organizations, out of reach today as they were in the eighties. We can argue that a lot of the concepts that swirl around Quality 4.0 is just trying out new technologies to see if we meet those objectives.
We can, and should, discuss the particulars of the System of Profound Knowledge. For me, it makes an excellent departure point for what we should be striving for. By looking to the past we can discover…
A SME is engaged in knowledge management activities, what we want is for those activities to be a explicit and systematic management of the processes of creating, gathering, validating, categorizing, archiving, disseminating, leveraging, and using knowledge – whether for improving the organization and the individuals in it or the broader profession.
The thing is, this is another skill set for most SMEs. There will be SMEs out there who can do this from practice, but we need to be more deliberate in providing the skills. To provide the skills we must understand what we need to teach, which is where a competency model is valuable.
Basic: Possesses general, conceptual knowledge or awareness of this concept OR a limited ability to perform this skill. Needs reference materials to complete tasks related to this concept.
Intermediate: Able to apply knowledge of this concept in work OR can perform this skill consistently with minimal guidance.
Advanced: Provides expert advice and make sound judgments using knowledge of this concept OR provides consultation and leadership to others using this skill. Can foster greater understanding of this concept among colleagues and stakeholders.
Competency
Level to build towards
Knowledge of principles of knowledge management, for example conceptualizing, managing, preserving, and/or maintaining organizational knowledge.
Knowledge of methods and techniques for disseminating and/or sharing knowledge across individuals, groups, and organizations.
Advanced
Skill in designing and implementing knowledge management strategy.
Intermediate
Skill in identifying the quality, authenticity, accuracy, impartiality, and/or relevance of information from various sources, for example databases, print and online media, speeches and presentations, and observations.
Advanced
Skill in organizing and synthesizing information from multiple sources, for example databases, print and online media, speeches and presentations, and observations.
Advanced
Skill in curating instructional content, tools, and resources, for example researching, evaluating, selecting, and/or assembling publicly available online courseware.
Basic
Skill in identifying the type and amount of information needed to support the development of others in the topic.
Advanced
Skill in developing, managing, facilitating, and/or supporting knowledge networks and communities of practice.
Advanced
We need to recognize that not every SME will get to this level, or have the time to consistently apply it. This is why it is important to have knowledge management experts to support, nurture and step in where needed to assist.
Previously I’ve talked about defining the values and behavior associated with quality culture. Once you’ve established these behaviors, a key way to make them happen is through microfeedback, a skill each quality professional, supervisor, and leader in your organization should be trained on.
We are all familiar with the traditional feedback loop: you receive feedback, reflect on it, make a plan, and then take action. This means feedback is given after a series of actions have taken place. Feedback addresses a few key observations for future improvements. In a situation when actions and sequences are quite complicated and interdependent, feedback can fail to provide useful insights to improve performance. Micro-feedback potentially canbe leveraged to prevent critical mistakes and mitigate risks, which makes it a great way to build culture and drive performance.
Micro-feedback is a specific and just-in-time dose of information or insights that can reduce gaps between the desired behavioral goals and reality. Think of it as a microscope used to evaluate an individuals comprehension and behavior and prescribe micro-interventions to adjust performance and prevent mistakes.
Microfeedback, provided during the activity observed, is a fundamental aspect of the Gemba walk. These small tweaks can be adapted, and utilized to provide timely insights and easy-to-accomplish learning objectives, to drive deep clarity and stay motivated to modify their performance.
Where and when the microfeedback happens is key:
1. Task–based microfeedback focuses corrective or suggestive insights on the content of a task. To provide higher impact focus micro-feedback on the correct actions rather than incorrect performance. For example “Report this issue as an incident…”
2. Process-based micro-feedback focuses on the learning processes and works best to foster critical thinking in a complex environment. For example, “This issue can be further processed based on the decision tree strategies we talked about earlier.”
3. Self-regulation-based micro-feedback focuses on giving suggestive or directive insights helping individuals to better manage and regulate their own learning. For example, “Pause once you have completed the task and ask yourself a set of questions following the 5W2H formula.”
For microfeedback to be truly successful it needs to be in the context of a training program, where clear behavorial goals has been set. This training program should include a specific track for managers that allows them to provide microfeedback to close the gap between where the learner is and where the learner aims to be. This training will provide specific cues or reinforcement toward a well-understood task and focus on levels of task, process, or self-regulation.
During change management, provide positive micro-feedback on correct, rather than incorrect, performance. This can be very valuable as you think about sustainability of the change.
Leveraged sucessful, but well trained observers and peers, microfeedback will provide incremental and timely adjustments to drive behavior.
Specialty Process Labs LLC is a specialty API manufacturer of natural desiccated thyroid. Which is, yes, what you might think it is. And as far I can tell, mostly ships direct to compounding pharmacies and patients. This month they got a warning letter.
The warning letter highlights:
Failure to validate the process
Failure to test to specification
Failure to exercise sufficient controls over computerized systems
All three of these observations make me rather glad my loved-ones take levothyroxine and I am deeply aware of all the difficulties in that drug supply.
Focusing more on the computer system, it is an unsurprising list of bad access controls, change controls not controlled, and failure to validate excel spreadsheets.
The last observation really stood out to me:
“Manufacturing master batch records held in electronic form on your company’s shared drive do not have restrictions on user access. Your quality unit personnel stated that there are no restrictions for any personnel with login credentials to access new and obsolete master records. Our investigator observed during the inspection multiple versions of batch records were utilized for API lot production.”
This is truly a failure in document access and record management. And it is one I see a lot of places. The core requirement here is really well stated in the PIC/S Data Integrity Guidance requirement 8.4 “Expectations for the generation, distribution and control of records.” Please read the whole section, but pay close attention to the following:
Documents should be stored in a manner which ensures appropriate version control.
Master documents should contain distinctive marking so to distinguish the master from a copy, e.g. use of coloured papers or inks so as to prevent inadvertent use.
Master documents (in electronic form) should be prevented from unauthorised or inadvertent changes.
Document issuance should be controlled by written procedures that include the following controls:
details of who issued the copies and when they were issued; clear means of differentiating approved copies of documents, e.g. by use of a secure stamp, or paper colour code not available in the working areas or another appropriate system;
ensuring that only the current approved version is available for use;
allocating a unique identifier to each blank document issued and recording the issue of each document in a register; – numbering every distributed copy (e.g.: copy 2 of 2) and sequential numbering of issued pages in bound books;
where the re-issue of additional copies of the blank template is necessary, a controlled process regarding re-issue should be followed with all distributed copies maintained and a justification and approval for the need of an extra copy recorded, e.g.: “the original template record was damaged”;
critical GMP/GDP blank forms (e.g.: worksheets, laboratory notebooks, batch records, control records) should be reconciled following use to ensure the accuracy and completeness of records; and
where copies of documents other than records, (e.g. procedures), are printed for reference only, reconciliation may not be required, providing the documents are time-stamped on generation, and their short-term validity marked on the document
There are incredibly clear guidelines for these activities that the agencies have provided. Just need to use them.
Investigations of a Dog 