Effective Organizations — Think Different

Effectiveness I recently had a bit of a wake-up call via Twitter. I asked the following question: “What’s the one thing /above all/ that makes for an effective organisation?” My thanks to all those who took the time to reply with their viewpoint. The wake-up call for me was the variety of these responses. All […]

via Effectiveness — Think Different

Great thought-piece over on “Think Different” on effectiveness, with a nice tie-in to Donnella Meadow’s “Twelve Leverage Points to Intervene in a System.”

In quality management systems, it is critical to look at effectiveness. If you do not measure, you do not know if the system is working the ways you expect and desire.

We often discuss lagging (output measurement) and leading (predictive) indicators, and this is a good way to start, but if we apply System Thinking and use Meadow’s twelve leverage points we can see that most metrics tend to be around 7-12, with the more effective levers being the least utilized.

I think there are a lot of value in finding metrics within these levers.

So for example, a few indicators on the effectiveness of lever 4 “The Power to Add, Change, Evolve, or Self-Organize System Structure”:

Lagging Leading
Effective CAPAs to the System Number of changes initiated by level of organization and scale of change
Deviation Reduction


Improving But Not Learning by Doing

Alex Tarbok on Marginal revolution wrote “Improving But Not Learning by Doing” looking at a paper “Causal understanding is not necessary for the improvement of culturally evolving technology” — which has interesting things to say to those interested in knowledge management. In short it demonstrates that the complex problems we have today need to be approached multi-dimension approach, in short system thinking is required to do true knowledge management.

Knowledge management Circular_Process_6_Stages (for expansion)

Throughout the six stages we need to be evaluating for complexities and interfaces. It is very easy to think in a silo and then create bigger problems done the line.

The DIKW pyramid is a great resource to keep in mind here.dikw pyramid

  • —Data comprises facts, observations, or perceptions
  • —Information is a subset of data, only including those data that possess context, relevance, and purpose
  • Knowledge is —Information with direction, i.e., leads to appropriate actions
  • Wisdom is the understanding of the why

I know that in many knowledge management models wisdom is often discounted, but that is to our detriment. Quality is often all about the why, whether a regulatory commitment, or a deep understanding of history, or as is relevant here , the relationship between parts of a complex system (or the interrelationship between systems).

Change Management of multi-site implementations

A colleague asks in response to my post Group change controls:

… deploying a Learning + documentation system … all around the word [as a global deployment]  … do we I initiate a GLOBAL CC or does each site created a local CC.

The answer is usually, in my experience, both.

Change management is about process, organization, technology and people. Any change control needs to capture the actions necessary to successful implement the change.

so at implementation I would do two sets of changes. A global to capture all the global level changes and to implement the new (hopefully) harmonized system And then a local change control at each site to capture all the site impact.

System Element Global Local
Process Introduce the new global process

Update all global standards, procedures, etc

How will local procedures change? How will local system interactions change – clean up all the local procedures to ensure the point to the new global procedures and are harmonized as necessary.
Technology Computer system validation

Global interfaces

Global migration strategy

Local interfaces (if any) and configurations

Are local technologies being replaced? Plan for decommissioning.

Local migration (tactical)

People What do people do on the global level?

How will people interact within the system in the future?

Global training

What will be different for people at each individual site?

Localized training

Organization Will there be new organizational structures in place? Is this system being run out of a global group? How will communication be run.

System governance and change management

Site organization changes

How will different organizations and sub organizations adopt, adapt and work with the system

If you just have a global change control you are at real risk of missing a ton of local uniqueness and leaving in place a bunch of old ways of thinking and doing things.

If you just do local change controls you will be at risk of not seeing the big picture and getting the full benefits of harmonization. You also will probably have way too many change controls that regurgitate the same content, and then are at risk of divergence – a compliance nightmare.

This structure allows you better capture the diversity of perspectives at the sites. A global change control tends to be dominated by the folks at each site who own the system (all your documents and training folks in this example), while a site change will hopefully include other functions, such as engineering and operations. Trust me, they will have all sorts of impact.

This structure also allows you to have rolling implementations. The global implements when the technology is validated and the core processes are effective. each site then can implement based on their site deliverables. useful when deploying a document management system and you have a lot of migration.

Multisite changes

As part of the deployment make sure to think through matters of governance, especially change management. Once deployed it is easy to imagine many changes just needing a central change control. But be sure to have thought through the criteria that will require site change controls – such as impact other interrelated systems, site validation or different implementation dates.

I’ve done a lot of changes and a lot of deployment of systems. This structure has always worked well. I’ve never done just a global and been happy with the final results, they always leave too much unchanged elements behind that come back to haunt you. In the last year I’ve done 2 major changes to great success with this model, and seen one where the decision not to use this model has left us with lots of little messes to clean up.

As a final comment, keep the questions coming and I would love to hear other folks perspectives on these matters. I’m perpetually learning and I know there are lots of permutations to explore.

Forget the technology, Quality 4.0 is all about thinking

Quality 4.0 is Industry 4.0 which is really just:

  • A ton of sensors (cheap, reliable sensors for everyone)
  • Data everywhere! (So much data. Honest data is good. Trust us.)
  • Collaboration (Because that never happened before technology)
  • Machine learning (this never ends well in the movies)

However, Quality 4.0 is really a lot more than the technology, it is all about using that technology to improve our quality management systems. So Quality 4.0 is really all about understanding that the world around us, and thus the organizations we work in, is full of complex and interconnected challenges and increasingly open systems of communication, and that we can no longer afford to address complex issues as we have in the past. The very simple idea behind Quality 4.0 is that current and future challenges requires thinking that is consistent with a living world of complexity and change.

As such there is nothing really new about Quality 4.0; it is just a consolidation of a lot of themes of change management, knowledge management and above all system thinking.

System Thinking requires quality professionals to develop the skills to operate in a paradigm where we see our people, organizations, processes and technology as part of the world, a set of dynamic entities that display continually emerging patterns arising from the interactions among many interdependent connecting components.

There are lots of tools and methodologies for managing systems. Frankly, a whole lot of them are the same that have been in use in quality for decades; others are new tools. The crucial thing to remember about Quality 4.0 is that it is an additive and transformative way to look at quality, and quite frankly one can go back and read Deming and see the majority of this there.

When I work on systems (which is according to my job description my core function), I keep some principles always in mind.

Principle Description
Balance The system creates value for the multiple stakeholders. While the ideal is to develop a design that maximizes the value for all the key stakeholders, the designer often has to compromise and balance the needs of the various stakeholders.
Congruence The degree to which the system components are aligned and consistent with each other and the other organizational systems, culture, plans, processes, information, resource decisions, and actions.
Convenience The system is designed to be as convenient as possible for the participants to implement (a.k.a. user friendly). System includes specific processes, procedures, and controls only when necessary.
Coordination System components are interconnected and harmonized with the other (internal and external) components, systems, plans, processes, information, and resource decisions toward common action or effort. This is beyond congruence and is achieved when the individual components of a system operate as a fully interconnected unit.
Elegance Complexity vs. benefit — the system includes only enough complexity as is necessary to meet the stakeholder’s needs. In other words, keep the design as simple as possible and no more while delivering the desired benefits. It often requires looking at the system in new ways.
Human Participants in the system are able to find joy, purpose and meaning in their work.
Learning Knowledge management, with opportunities for reflection and learning (learning loops), is designed into the system. Reflection and learning are built into the system at key points to encourage single- and double-loop learning from experience to improve future implementation and to systematically evaluate the design of the system itself.
Sustainability The system effectively meets the near- and long-term needs of the current stakeholders without compromising the ability of future generations of stakeholders to meet their own needs.

In order to be successful utilizing these principles when designing systems and processes we need to keep user at the forefront — striving to be sensitive to the user, to understand them, their situation and feelings: to be more empathetic.

components of empathy

We leverage both the affective component and the cognitive component of empathetic reasoning, in short we need to both share and understand.

We are in short asking 5 major questions:

  • What is the purpose of the system? What happens in the system?
  • What is the system? What’s inside? What’s outside? Set the boundaries, the internal elements and elements of the system’s environment.
  • What are the internal structure and dependencies?
  • How does the system behave? What are the system’s emergent behaviors and do we understand their causes and dynamics?
  • What is the context? Usually in the terms of bigger systems and interacting systems.

Think holistically, think empathetically with the user, and ask questions about system behavior. Everything else falls into place from there.

Knowledge Work is the product

Johanna Rothman recently provided some insightful thoughts about Project Work vs Product Work. While focused on software, Johanna has some points that are valuable outside of software as she focuses on the importance of long-lived teams, applying a product work mindset to team functions.

The more we create long-lived teams who have already learned how to work together, the easier it is to work together. Even if that work is project-based work.

I think the critical thing for me is how much we have to view each team, each project as having as one of it’s key deliverables knowledge management.

However, we also need to recognize that in this day-and-age the modern corporation is  a transient collective. Companies do not do a great job of showing loyalty, there are a lot of options for the modern knowledge worker, and people regularly move on.

For me, this is why it is so important for not just projects, but day-to-day work to have as part of the inherent ways of working, processes to bring the tacit to explicit. The lessons-learned is a great place to start but we should be constantly be striving to identify “what have we learned”, “what do we need to make explicit” and “how do we make it explicit” as part of our work.

Knowledge management Circular_Process_6_Stages (for expansion)

Returning to the 6 stages of knowledge management:

    1. Have a way to capture what knowledge bits. For example, if you have a visual board, make sure this is explicitly part of the board. Make it part of your day-to-day.
    2. As a team assess the collected captured (and generated) knowledge and determine what is suitable for retaining.
    3. Share it – pass it up, pass it down. Make it available by tying it into your companies knowledge management system.
    4. Turn it into artifacts that are reusable. Pre-job briefings, procedures, work instructions, whatever is relevant.
    5. Live it. Confirm you are using it.
    6. Remember knowledge management artifacts are living. Things change and need to be updated. We can always refine. Continuous improvement is key.


Computer system changes and the GAMP5 framework

Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.

21 CFR 211.68(b)

Kris Kelly over at Advantu got me thinking about GAMP5 today.  As a result I went to the FDA’s Inspection Observations page and was quickly reminded me that in 2017 one of the top ten highest citations was against 211.68(b), with the largest frequency being “Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. ”

Similar requirements are found throughout the regulations of all major markets (for example EU 5.25) and data integrity is a big piece of this pie.

So yes, GAMP5 is probably one of your best tools for computer system validation. But this is also an argument for having one change management system/one change control process.

When building your change management system remember that your change is both a change to a validated change and a change to a process, and needs to go through the same appropriate rigor on both ends. Companies continue to get in a lot of trouble on this. Especially when you add in the impact of master data.

Make sure your IT organization is fully aligned. There’s a tendency at many companies (including mine) to build walls between an ITIL orientated change process and process changes. This needs to be driven by a risk based approach, and find the opportunities to tear down walls. I’m spending a lot of my time finding ways to do this, and to be honest, worry that there aren’t enough folks on the IT side of the fence willing to help tear down the fence.

So yes, GAMP5 is a great tool. Maybe one of the best frameworks we have available.



Document Management

Today many companies are going digital, striving for paperless, reinventing how individuals find information, record data and make decisions. It is often good when undergoing these decisions to go back to basics and make sure we are all on the same page before we proceed.

When talking about document management we are really discussing three major types or functions:

  • Functional Documents provide instructions so people can perform tasks and make decisions safely effectively, compliantly and consistently. This usually includes things like procedures, process instructions, protocols, methods and specifications. Many of these need some sort of training decision. Functional documents should involve a process to ensure they are up-to-date, especially in relation to current practices and relevant standards (periodic review)
  • Records provide evidence that actions were taken and decisions were made in keeping with procedures. This includes batch manufacturing records, logbooks and laboratory data sheets and notebooks. Records are a popular target for electronic alternatives.
  • Reports provide specific information on a particular topic on a formal, standardized way. Reports may include data summaries, findings and actions to be taken.

Often times these types are all engaged in a lifecycle. An SOP directs us to write a protocol (two documents), we execute the protocol (a record) and then write a report. This fluidity allows us to combine the types.

Throughout these types we need to apply good change management and data integrity practices (ALCOA).

All of these types follow a very similar path for their lifecycle.

document lifecycle

Everything we do is risk based. Some questions to ask when developing and improving this system include:

  • What are the risks of writing procedures at a “low level of detail versus a high level of detail) how much variability do we allow individuals performing a task?) – Both have advantages, both have disadvantages and it is not a one-sized fits all approach.
  • What are the risks in verifying (witnessing) non-critical tasks? How do we identify critical tasks?
  • What are the risks in not having evidence that a procedure-defined task was completed?
  • What are the risks in relation to archiving and documentation retrieval?

There is very little difference between paper records and documents and electronic records and documents as far as what is given above. Electronic records require the same concerns around generation, distribution and maintenance. Just now you are looking at a different set of safeguards and activities to make it happen.