Procedure Lifecycle

We write and use procedures to help the user complete the task successfully and avoid undesired outcomes. Well-written procedures are an integral part of any organization for operation, managing risks, and continuous improvement. Effective procedures are important for the transfer of knowledge from the engineers/architects of the system to the users of the system.

Good procedures, and we are not talking format so this can be paper documents to a mixed reality guide, provide these four categories of information:

  1. Goal: The goal presented to the user as a state to be realized. This can be an end state or an intermediate state of the overall system.
  2. Prerequisites: The condition for moving toward the desired state or goal. These are the conditions that must be satisfied so that the user can achieve the goal.
  3. Actions and reactions: These states are reached through actions of the user and the reactions of the system. They may have milestones or sub-goals. It involves the description of (a series of) action steps.
  4. Unwanted: These are the states to be avoided (e.g., errors, malfunctions, injuries). It provides guidelines on what to avoid for successful and safe execution of procedure and may include warning, caution, or instruction for solving a potential problem.

Procedures have a lifecycle through which they are developed, administered, used, reviewed, and updated. In the post “Document Management” I discussed the document management lifecycle.

In want to focus specifically on procedures by covering five distinct phases: procedure plan, design and development, procedure authorization, procedure administration, procedure implementation and use, and procedure review and maintenance.

Outlines the 5 phases of a procedure lifecycle
Lifecycle of a procedure
PhaseIncludesDocument Management Steps
Procedure plan, design and developmentIdentifying whether a procedure is necessary; collecting required information; producing instructions and information on the work, regulatory compliance, process and personnel safety; a walkthrough to ensure quality and potential compliance of the procedure“New SOP is needed”   Drafting    
Procedure AuthorizationProcedure review; publishing the final document; revision control; the approval process.Review Approval
Procedure AdministrationManaging procedure repository, control, and deployment; identifying administers how, when, and to whom procedures are to be delivered. 
Procedure Implementation and UseProcedure is used in operations 
Procedure review and maintenancePeriodic review of documents, as well as updates from the CAPA and Change Management processesPeriodic Review


  • Procedure Professionals Association (PPA), 2016. Procedure Process Description. (PPA AP-907-001)
  • Van der Meij, H., Gellevij, M., 2004. The four components of a procedure. IEEE Trans. Prof. Commun. 47 (1), 5–14

Identifying Waste in Risk Management

Risk Management often devolves into a check-the-box, non-valued activity in an organization. While many organizations ensure they have the right processes in place, they still end up not protecting themselves against risk effectively. A lot of our organizations struggle to understand risk and apply this mindset in productive ways.

As quality professionals we should be applying the same improvement tools to our risk management processes as we do anything else.

To improve a process, we first need to understand the value from the process. Risk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.

Risk management then is an application of decision quality to reduce uncertainty on objectives. We can represent the process this way:

The risk evaluation is the step where the knowledge base is evaluated, and a summary judgment is reached on the risks and uncertainties involved in the case under investigation. This evaluation must take the values of the decision-makers into account and a careful understanding has to be had on just what the practical burden of proof is in the particular decision.

Does Risk Management then create value for those perceived by the stakeholders? Can we apply a value stream approach and look to reduce wastes?  Some common ones include:

Waste in Risk ManagementExampleReflects
Defective Information“The things that hurts you is never in a risk matrix”  “You have to deliver a risk matrix, but how you got there doesn’t matter”Missing stakeholder viewpoints, poor Risk Management process, lack of considering multiple sources of uncertainty, poor input data, lack of sharing information
Overproduction“if it is just a checklist sitting somewhere, then people don’t use it, and it becomes a wasted effort”Missing standardization, serial processing and creation of similar documents, reports are not used after creation
Stockpiling Information“we’re uncertain what are the effect of the risk as this early stage, I think it would make more sense to do after”Documented risk lay around unutilized during a project, change or operations
Unnecessary movement of people“It can be time consuming walking around to get information about risk”Lack of documentation, risks only retrievable by going around asking employees
Rework“Time spend in risk identification is always little in the beginning of a project because everybody wants to start and then do the first part as quickly as possible.”Low quality initial work, ‘tick the-box’ risk management
Information rot“Risk reports are always out of date”The documents were supposed to be updated and re-evaluated, but was not, thus becoming partially obsolete over time
Common wastes in Risk Management

Once we understand waste in risk management we can identify when it happens and engage in improvement activities. We should do this based on the principles of decision quality and very aware of the role uncertainty applies.


  • Anjum, Rani Lill, and Elena Rocca. “From Ideal to Real Risk: Philosophy of Causation Meets Risk Analysis.” Risk Analysis, vol. 39, no. 3, 19 Sept. 2018, pp. 729–740, 10.1111/risa.13187.
  • Hansson, Sven Ove, and Terje Aven. “Is Risk Analysis Scientific?” Risk Analysis, vol. 34, no. 7, 11 June 2014, pp. 1173–1183, 10.1111/risa.12230
  • Walker, Warren E., et al. “Deep Uncertainty.” Encyclopedia of Operations Research and Management Science, 2013, pp. 395–402, 10.1007/978-1-4419-1153-7_1140
  • Willumsen, Pelle, et al. “Value Creation through Project Risk Management.” International Journal of Project Management, Feb. 2019, 10.1016/j.ijproman.2019.01.007

Rocky Road to ICH Q12 Implementation

Prior to the adoption of Q12 in Singapore at the end of 2019 there was a lot of rumbling from regulatory agencies on how Q12 would be more aspirational in many ways. In the last few weeks we’ve started to see just what that will mean.

FDA to release a guidance

The FDA’s Mahesh Ramanadham, from the Office of Pharmaceutical Quality in the FDA’s Center for Drug Evaluation and Research, provided an update on the agency’s implementation of ICH Q12 in the US on 25 February at the annual IFPAC meeting in North Bethesda, Md. He started that the FDA will soon be issuing guidance implementing the International Council on Harmonization’s Q12 guideline in the US that will, among other things, translate ICH post-approval change classification categories to FDA supplement categories, and address how to file established conditions (ECs).

This Q12 guidance will replace the agency’s 2015 draft guidance for industry on established conditions and reportable chemistry, manufacturing and controls changes to approved drug and biological products. It is expected to be issued in May 2020. The guidance will also discuss the relationship between FDA comparability protocols and the post-approval change management protocol (PACMP) established by the ICH Q12 guideline.

EU says not so fast in their adoption

However, additional scientific risk-based approaches to defining Established Conditions and
associated reporting categories, as described in Chapter 3.2.3, and the Product Lifecycle
Management (PLCM) Document, as described in Chapter 5, are not considered compatible with the
existing EU legal framework on variations.

It is important to note that the legal framework always takes precedence over technical and
scientific guidelines. More specifically this means that the definition of Established Conditions and
their reporting categories must follow the requirements laid down in the current EU Variations
Regulation and associated EU Variations Guidelines. With respect to the Product Lifecycle
Management (PLCM) document, in case such a document is submitted, it cannot be currently
recognised in the EU due to the fact that it is not referred to in the EU legal framework.


In an explanatory note accompanying the adoption of ICH Q12 and related annexes, the European Commission and the European Medicines Agency point out that there are “some conceptual differences” between the ICH guideline and the EU legal framework on managing post-approval changes, ie, the variations regulation (Regulation (EC) No 1234/2008).

The EU authorities offer no clarity on when and how ICH Q12 would be fully implemented in the EU. The note merely states that the new “tools and concepts in the ICH Q12 guideline that are not foreseen in the EU legal framework will be considered when this framework will be reviewed.” The EU regulators said they would continue to work on the implementation of the ICH Q12 within the existing EU legal framework. The explanatory note also points out that despite some conceptual differences between ICH Q12 and the EU framework, there is also considerable common ground. In fact, some tools and concepts in ICH Q12 tools can already be applied by industry by following the current EU variations framework.

Next Steps

Companies should be ensuring that their knowledge management and risk management processes and understanding continue to grow. ICH Q12 will be a rocky road and I’m not sure we’ll see some of the potential streamlining of regulatory processes for a long time.

ICH Q12 pathway for established conditions

ASQ Lean and Six Sigma Conference – Day 2

I ran into Stuart MacDonald, the magician from yesterday in several sessions today. I love when keynotes at a conference show their passion by learning from fellow practitioners. I bought his book, so it also worked on that level.

Morning Keynote of “Achieving Operational Excellence with Passion and Creativity” by Kaplan Mobray

As a facilitator I always approve of walking into a session with a name tag, file cards, paper, and crayons. It warms my heart.

Career coaches and motivational speakers are a tough one for me as I rarely connect with them as a conference speaker. Mr. Mobray had a high energy level, but what I really enjoyed was him using various facilitation techniques (graphic drawing) as a way to focus on his simple points, such as “pass it on” or “evolve” or “progress over persecution.”

“Steering Towards Zero Issues” by Franco Seravalli

Starts with the dilemma of poor quality and a high level overview of the case study at an automobile parts supplier in Costa Rica.

Though his case study covered their path root cause analysis and gap analysis and then went to improvement strategy.

  • People – Trust our people
  • Containment
  • Correction/Prevention

People was the most important.

Step by step process to create a quality culture and sell change.

Steps for strengthening people

Focus on people and talked about human error and human performance.

  • Awareness – create a sense of pride and empathy with the customer. Transparency and candor and making the quality issues public
  • Commitment – Public displays of support. Talk and listen. Management walking-the-walk
  • Empowerment – Trust your people, decision-making authority
  • Accountability – interesting point about cultural differences (for example Spanish and Portuguese do not have this word)
  • Recognition
Credit where credit is due

Containment – focused on stop the bleeding and close the circle. Containment is fairly high level and felt very industry specific in his details.

Corrective Actions – laid out the typical deviation to CAPA to effectiveness review path. Covered 8D, talking about need to add risk analysis/management and the place of effectiveness reviews.

Covers risk and PFMEAs.

Again, not an intermediate discussion. We need better criteria for ranking a session. I would have gone to this even if it was marked basic as the speaker is a member of the Team and Workplace Excellence Forum, but I worry for other participants.

“See One, Do One, Go Do One” by Karissa Craig

Karissa laid out a journey to develop, trial, implement, evaluate, and refine their approach through a case study.

Brings a good qualification approach to Lean with “See One” and “Do One” are classroom learning and the “Go Do One” is application.

Talked about the resistance and the need for accountability for application. A “want to” and not a “have to”

Demonstrated the A3 as rubric for the “Go Do One”. Offered some good discussion of how firefighter cultures (which healthcare) and how you need to build the right culture to do problem and root cause and not jump to solutions.

Gave a nice 8-week (with added 1-week pre, 1-week post) schedule for training and doing.

For training focused on basic problem solving, talked about avoiding perfectionism and set reasonable expectations. Karissa described a great sounding training program. This three hour class seemed very well put together.

Had an interesting share on how training led people to realize that problem solving was harder than they used to think and impacted employee engagement. This led to a sponsor training so sponsors understood how to support teams.

“Run with scissors” about how transformation involves risk and the ways to deal with it.

Rest of the Day

I spent the afternoon networking and connecting and conducting some ASQ Team and Workplace Excellence Forum business and didn’t attend any of the afternoon sessions. I was ambivalent about the afternoon keynote speaker/piano player.

ASQ Lean and Six Sigma Conference – Day 1

Back again this year in sunny Phoenix for the ASQ Lean and Six Sigma Conference

These are all my rough, first draft impressions. So it will be mostly stream of conscience.

The Six Sigma Forum Award for the Advancement of Six Sigma is a mouth full. Dr Jamison Kovach. Awards are one part of the professional society experience that I do not really understand why we do them, but Dr Kovach has contributed to the field and is certainly deserving. I’m glad to see her get all the recognition that we can give her for her continued contributions.

Morning keynote is “The Art of Leading Change in the Age of Quality 4.0” by Greg Watson

Greg is a distant past president of the ASQ, and I think it is important to stress distant as that perspective informs much of his speaking. Whenever I hear Greg I always feel like I’m back in the late 1990s and then I have an urge to check on y2k projects.

But as a consultant, he had to get on board with the tsunami that is industrial transformation. And to be fair, I’m impressed by the approach he is taking.

He references an article from Richard Young from 2001 and then draws a path to “thinking systems.” He makes a good point that quality is never settled, and we need to use the past to set the future and asks the question of “can we simplify our way of pursuing quality in a digital world.”  Going back to profound knowledge he talks about organizational excellence and how we need architects that blend science, mathematics and engineering with artistic thinking to create a functional system that weathers its potential environment and is attractive to customers.

That is good. And then he went back to the 60s and I might have taken a nap. Don’t get me wrong, I love history and it’s important to understand it, but there might be a problem with understanding of quality 4.0 if we need to reference early days to make points.

Offers a definition of quality as “Quality is the relentless pursuit of goodness coupled tightly with the persistent avoidance of badness.” Break down to a product quality definition, service quality definition, process quality definition.

  • Product quality: Fit for use by the customer in the intended application and the actual environment.
  • Service quality: Consistent delivery of the desired service level over an extended period of time and across all locations.
  • Process quality: Maximizing the level of productivity relative to the customer demand with minimal waste, cost, inefficiency or loss

To get to quality 4.0 we must become trusted advisors and coaches to the executive team. Quality as lifeblood of the organization. Question we need to ask is how do I become that type of person

Organization Excellence three types of improvement:

  • Continual Improvement – Process focus, work changes
  • Breakthrough Projects – technology
  • Transformation projects – game changers in redirecting the purpose of organizational strategic intent

Hits on an issue I know many quality people grind their teeth on, especially in pharma

Managing organizational gemba the nature and structure of each Gemba changes in focus and content and must be improved in different ways

Quality characteristicGemba #1Gemba 2Gemba 3
Customer focusWorkersCustomersOwners
Work objectivesWork productivityWork priorityWork Profitability
Dominant functionPerform/operateSupervise/ManageCommand/Control
Performance focusFlow efficiencyProductivityResource efficiency
Performance approachQuality/efficiencyProductivity growthFinancial growth
Quality mindsetRight the first timeService the CustomerGet business results
Team approachWork group/circleProgram/ProjectCommittee/Council
  • Gemba 1 is continual improvement
  • Gemba 2 Breakthrough
  • Gemba 3 is transformation

Goes back to profound knowledge as delivering a systemic view of how work is carried out so that future performance may be predicted with a string degree of probability.

  • Systemic perspective
  • Managing the knowledge domain
  • Predictive analytics
  • Human understanding

System thinking and how hoshin kanri defines the strategic front-end that identifies, manages and enables critical change projects to achieve desired organization goals.

Knowledge of variation is a way that establishes change targets and sets priorities in a way that does not use unreasonable stretch targets the demotivate workers or spread fear.

Building worker competence and agility will enable people-intensive processes to run as an effective support system for the digital tools employed in deploying quality 4.0.

Profound knowledge enables insights necessary to design systems of fture and provide checks and balances to assure managerial oversight of

How to manage change

  • Operationalize profound knowledge across aly management system
  • Facilitate business improvement change
  • Balance resources

I’m really mixed by this presentation. There were some good points, but I really feel they get buried underneath the continued hearkening back to the 1980s and 1990s. Our history is important, but it shouldn’t bury us.

“Lean Transformation Lessons for Practitioners and Students” by Nicole Radziwill and Rebecca Simmons.

Rebecca is an assistant professor at James Madison University and a member of the Team and Workplace Excellence Forum and Nicole is one of the better thinkers on the impact of industrial transformation (IX) and Quality 4.0. Nicole wasn’t able to make the conference but is online. This means the presentation was a little different than expected but handled well.

Defined lean transformation as “installing the habits and practices that will enable yur organization to deliver a continuous flow of value to customers”

This cannot happen without cultural shift and stresses the importance of learning-by-doing. Old-habits to break, learning is easier than unlearning. Change requires cognitive energy and people are selective about where they spend that energy.

Click to access Markus1983_CACM266_PowerPoliticsMIS.pdf

Identify the Need

Is Lean the right approach? Some traditional questions but focused on very good question:

  • Employee turnover is high
  • Always short staffed
  • Cross functional conflict
  • Frequent pivoting

Power of observation, indicators of culture         

  • Are people first? – this is a good thing to develop a tool on what and how to observe interactions to see this?
  • Who has accountability & ownership?
  • How are mistakes handled?

Examine the system, follow the question

Assess Readiness

Once need and lean is right approach, is organization ready.

Can the organization absorb any additional change efforts? Capacity is finite and what else is going on? Is there a reasonable chance of success for this specific change? Time out – is no the right time?

Is there a reasonable chance of success for this specific effort?

Leadership engagement  – questions about time resources and actual commitement as self-discipline. Sustained hard work over time. Commitement is not enough

Process definition – enough to start but not enough that this is not value added. Who gets blamed when there is a problem?

Process stability – may need to triage first

Covered the visual triange. Information is power and sharing information with everyone in the facility means giving up control and power and this is very telling of true level of commitement.

Covers the sources of resistance and has a table based on 1993 study

Talks about importance of power balance and how shifts in power balance can create resistance.

Shared some good case studies. Love the fact they used the Baldridge as the rubric for the assessment.

Key Findings

  • Assess process maturity upfront
  • Build an organizational backbone – include standard work for leaders and “tech follows behavior” are good things emphasized here.
  • Create a sole source of truth which drives effective decision making
  • Design Strategic Quick Wins – the hardest project is not the first on to tackle. Leadership to recognize
  • Engage influencers and key executives

I then spoke.

“The Importance of PLAN in PDC/SA and DMAIC” by Grace Duffy

We need to make sure that our working level is comfortable with what they are doing. The above metric captures a balanced approach that Grace covered.

Ensured her audience was grounded on the idea of a perpetual system of improvement discussing how lean and six sigma fit together, with her concept of modular kaizen, linking back to benefits against an ideal cost of quality model. Coming back to a theory of constraints where resources and bottlenecks, finding the weak link in time.

Talks about the disruption loops as part of the PDCA loops of the modular kaizen approach. Discussed how we need to get people to think in terms of gap assessments. This is an interesting observation, and fits into a thread I’ve ben working on around situational awareness.

Building off on this Grace then covers a systems view of continuous operation.

Covering the seven step project sequence for modular kaizen improvement activities. I like her bringing QFD in here.

Overall assessment – I will go on the record again that I am a huge fan of Grace’s thoughts. She is an influential thinker in quality. I’ve also attended maybe 7 talks by Grace in the last two years and it has been interesting as she continues to refine and push ahead her system-based approach to continuous improvement.

“Practice Doesn’t Make Perfect, It Makes Habit” by Ryan Burge and Shrey Tarpara

Starting with a resistance of change, covering it at an extremely high level, hitting a little on individuals fear of changes.

The habit discussed is to build a habit of consideration around change. Briefly touched on risk management as part of analysis of change need.

Laid out a framework for dealing with resistance and fears around change.

Stuart MacDonald Keynote

Entertaining. I was really happy with this. I’m linking to his TED talk, which is a super abbreviated version of his talk.

Throughout the day I had great conversations with awesome people. My favorite part of a conference.

Tomorrow is Day 2. Looking forward to it.