What is in a title

Recently I’ve seen a few inspection observations that have provided an observation on the title of quality record (e.g. deviation, CAPA, change control).

The title might seem the most basic part of a quality system record – a simple task – but instead it should receive some serious thought. This is any inspector’s first interaction, it serves as a historical flag that generations of readers will use to become familiar. And everyone falls prey to “judging a book by its cover.” This cognitive bias tends to make readers considerably susceptible to allowing the quality systems title to function as the sole factor influencing their decision of whether to read or skip a record. A bad title could shape an inspection or deprive an important historical record from being evaluated in the future. We can do better.

A good quality systems record title:

Condenses the record’s content in a few words
Differentiates the record from other records of the same subject area

Some general tips:

Keep it simple and brief: The primary function of a title is to provide a precise summary of the record’s content. So keep the title brief and clear. Use active verbs instead of complex noun-based phrases, and avoid unnecessary details. Moreover, a good title for a record is typically around 10 to 12 words long. A lengthy title may seem unfocused and take the readers’ attention away from an important point.

Avoid: Wrong label issued

Better: Sample ABCD was issued label 1234 instead of label X4572

Use appropriate descriptive words: A record title should contain key words used in the record and should define the nature of the quality systems event. Think about terms people would use to search for your record and include them in your title.

Avoid: No LIMS label for batch ABDC

Better: Batch ABDC was missing label Y457 as required by procedure LAB-123

Avoid abbreviations and jargon: Known abbreviations can be used in the title. However, other lesser-known or specific abbreviations and jargon that would not be immediately familiar to the readers should be left out.

It sometimes surprises folks how simple things can have ripple effects. But they do, so plan accordingly and ensure your users are trained on writing a good title. Trust me; it will make things easier in the long run.

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.

ASQ Round up of quality blogs – change management

The ASQ Voices of Quality roundup on change management was posted today. I wrote my thoughts last week. After reading all of the consolidated blog posts I have a few more thoughts:

Avoid being reductive on change management. Everyone focuses on people, and then mentions how hard it is. I think part of this is the lack of system thinking. People use processes in an organization enabled by technology.
If you only pull out change management for the transformational projects you aren’t exercising it enough. It needs to be built into all continuous improvement activities.
Change Management is enabled by knowledge management and risk management. Without these in place and well understood, change management will be much harder than it should be.

Quality is about teaching

One of the core skills for a quality professional is teaching. We teach skills, ways of thinking, methodologies. “Great Employees Want to Learn. Great Managers Know How to Teach” by Daniel Dobrygowski nicely covers some key points that every quality professional should think through as we go through out day advocating for quality in our organizations.

Define goals and communicate them clearly

Part of this is an evangelical role. Quality needs to be able to explain the quality goals, whether of the organization of a specific system or process. People in your organization want to know why they are doing things. Spend some time having clear talking points, be ready to give your pitch. Speak proudly of your quality systems. And be ready to understand how other’s goals intersect with your own.

Identify and build skills

Understand the skills necessary for quality, develop a plan to assess and build them and then execute to it. Knowledge management is crucial here.

Create opportunities for growth

Quality raises the prospects of all. Quality professionals who realize that our core job is building skills and growing the people in our organization benefit from teaching will drive continuous improvement and make folks happier using our systems. Growth is a reward loop, and people feeling they are rewarded by your system will want to use it more.

In short take each and every opportunity to use your interactions as a way to grow skills and capabilities. Quality will only grow as a result.

What quality matters are on your radar?

What quality system concerns do you have? What are you investing time in figuring out? What are your best practices – the quality solutions you are proud to share?

The site I work at is under a consent decree (fairly late in the process now). I joined because I wanted the experience of building and refining quality systems in that environment and the last five years here have been incredibly rewarding for a whole host of reasons.

I started this blog because I had a whole host of things I wanted to share. It also serves as a reflective tool to refine several ideas that I am working on. The themes of change management, knowledge management, document management, risk management, computer systems and data integrity (amongst other things) are the items I have spent a lot of time on and are some of the topics driving the next stage of my career.

If I was to do a personal SWOT of where I am at (100% my opinions, does not represent anything official), it would look like this (with seasonal fall leaf structure):

SWOT - personal experience

It is not that hard to draw from these to my topics of interest.

I am following a tried-and-true technique, that of thinking aloud, which allows me to reflect upon and clarify the problem and focus on what is next. “Thinking aloud” requires talking through the details, decisions, and the reasoning behind those decisions. This slowing down the process allows me to fully comprehend the problem. This blog then serves to experiment, consider, and then decide upon next steps.

I’ll end this asking the same question I started with: What are your quality system concerns? What would you like to talk about on this blog?