In the post “Design Lifecycle within PDCA – Planning” I laid out a design thinking approach to planning a change.
Like most activities, the level of effort is commensurate with the level of risk. Above I provide some different activities that can happen based on the risk inherent in the process and problem being evaluated.
This is a great reason why Living Risk Assessments are so critical to an organization.
The Process Owner plays a central role as the sponsor of changes. As the process caretaker they ensure the change meets requirements.
In the post “Review of Process/Procedure” I mentioned how the document draft and review cycle can be seen as an iterative design cycle. In this post I want to expand on the design lifecycle as a fundamental expression of PDCA that sits at the heart of all we do.
PDCA (and it’s variants) are a pretty tried and true model for process improvement. In the PDCA model a plan is structured in four steps: P (plan) D (do) C (check) A (act). The intention is create a structured cycle that allows the process to flow in accordance with the objectives to be achieved (P), execute what was planned (D), check whether the objectives were achieved with emphasis on the verification of what went right and what went wrong (C) and identify factors of success or failure to feed a new process of planning (A).
Conceptually, the organization will be a fast turning wheel of endlessly learning from mistakes and seeking to maximize processes in order to remain forever in pursuit of strategic objectives, endlessly searching for the maximum efficiency and effectiveness of the system.
This design lifecycle just takes the PDCA spiral and spreads it across time. At the same time it breaks down a standard set of activities and recognizes the stage gates from moving between startup (or experiment) and continuous improvement.
At it’s heart problem-solving requires understanding a set of requirements and building for success.
I always go back to the IEEE definition of “A requirement is a condition or capability needed by a user to solve a problem or achieve an objective; a condition or capability that must be met or possessed by a system or system component to satisfy a contract ,standard, specification , or other formally imposed document; a document representation of condition or capability “
A requirement can be explicitly stated, implicit, inherited or derived from other requirements.
The first place to look for requirements is the organization itself.
The cultural needs of the organization drives the whole problem-solving and requirement gathering activity and it starts by being clear on Strategy and understanding the goals and objectives and how these goals percolate to the different business processes that we are improving. This gives a good starting point to focus on what opportunities to be explored and what problems to be solved.
It is not uncommon in the problem-solving phase that the objectives/needs are not known, so we must work our way through figuring out what the initial need is. Go back to the fundamentals of understanding the business processes “as-is” and review existing regulations, standards, guidelines and other internal sources of requirements followed currently. This is the time to interview stakeholders and go the GEMBA.
We state the problem, and re-frame it. And now we can move on to Requirement Elicitation.
Requirement Elicitation is the process of probing and facilitating the stakeholders to provide more clarity and granular details pertaining to the (usual) high-level requirement gathered so far. This is a discovery process, exploratory in nature, focusing on finding enough details so that a solution can be envisioned and developed. Elicitation is not an isolated activity, and has been happening throughout the process by all the discussion, interaction, analysis, verification and validation up to now.
You should be engaging with knowledge management throughout the cycle, but ensure there is specific engagement here.
It is a progressive process where the requirement clarity ushers in increments and may need multiple rounds of probing/discussions. As the new details are uncovered the requirements are further elaborated and detailed. There are a whole toolbox of elicitation techniques and like any engagement it is important to properly prepare.
Requirement Analysis pertains to extracting the requirement out of the heaps of information acquired from various stakeholders and communicated and turned into documentation in a form that is easily understood by the stakeholders, including the project team. Here we are engaging in requirement refinement, modification, clarification, validation & finalization and engaging in extensive communication.
A requirement can be classified as:
We build for traceability here, so as we build and test solutions we can always trace back to the requirements.
Building for the solution includes change management. Any solution focuses both on the technical, the organization and the people.
Ensure you leverage risk management.
In this design process, we address and use empathy to acquire insight into users’ (stakeholders) needs and inform the design process and create a relevant solution. Using an approach informed by cognitive empathy, we apply different methods to build up that competence and insight, enabling us to prioritize the needs of the users and make the results of the process more desirable.
Psychological safety, reflexivity and sense-making inform our work.
By engaging in Design Thinking we are ready for Startup. Moving through the three steps of:
We have created a plan to execute against. Startup, which can often be Experimentation, is it’s own, future, post.
The yearly database of 483s has been updated by the FDA. Lots will be written on themes as we end the year, so I decided to give a few of my immediate observations.
I find that over time what I focus in on changes, as my jobs evolve and change, and the interests I have shift. However, some things never change, so let us talk change.
| Reference Number | Short Description | Long Description | 2020 Frequency | 2019 Frequency | 2018 Frequency |
| 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved | Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, *** | 8 | 13 | 9 |
| 21 CFR 211.160(a) | Lab controls established, including changes | The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, *** | 4 | 18 | 17 |
| 21 CFR 212.20(c) | Adverse effects of changes made | You did not demonstrate that any change does not adversely affect the [identity] [strength] [quality] [purity] of your PET drug. Specifically,*** | 1 | 1 | 1 |
I think its fair to say the decreases as a result of the pandemic and the reduced inspections.
Over on the device side of things we see:
| Reference Number | Short Description | Long Description | Frequency |
| 21 CFR 820.30(i) | Design changes – Lack of or Inadequate Procedures | Procedures for design change have not been [adequately] established. Specifically,*** | 26 |
| 21 CFR 820.40(b) | Document change records, maintained. | Records of changes to documents were not [adequately] maintained. Specifically, *** | 6 |
| 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. | Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established. Specifically, *** | 5 |
| 21 CFR 820.75(c) | Process changes – review, evaluation and revalidation | A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, *** | 5 |
| 21 CFR 820.40(b) | Change records, content | Records of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective]. Specifically, *** | 3 |
| 21 CFR 820.50(b) | Supplier notification of changes | There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service. Specifically, *** | 3 |
| 21 CFR 820.75(c) | Documentation – review in response to changes or deviations | There is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations. Specifically, *** | 1 |
I’m a firm believer that pharma should always pay attention to the medical device side for 483s. A lot of us are combination products now (or will be) and there is always good trends to be aware of.
My key takeaways:
Here’s a more detailed checklist to help you evaluate your change system.
Today I spoke at the ASQ Lean and Six Sigma Conference on sustaining change. Great crowd (though I felt bad for the folks sitting on the floor) and the session has spawned a bunch of great conversations that I hope continues in the future.
Slides are here: https://investigationsquality.com/wp-content/uploads/2020/02/sustaining-change-executing-a-sustainability-plan.pptx
Investigations of a Dog 