Review of Process/Procedure

Review of documents are a critical part of the document management lifecycle.

In the post Process/Procedure Lifecycle there are some fundamental stakeholders:

The Process Owner defines the process, including people, process steps, and technology, as well as the connections to other processes. They are accountable for change management, training, monitoring and control of the process and supporting procedure. The Process Owners owns the continuous improvement of the overall process.
Quality is ultimately responsible for the decisions made and that they align, at a minimum, with all regulatory requirements and internal standards.
Functional Area Management represents the areas that have responsibilities in the process and has a vested interest or concern in the ongoing performance of a process. This can include stakeholders who are process owners in upstream or downstream processes.
A Subject Matter Expert (SME) is typically an expert on a narrow division of a process, such as a specific tool, system, or set of process steps. A process may have multiple subject matter experts associated with it, each with varying degrees of understanding of the over-arching process.

A Risk Based Approach

The level of review of a new or revised process/procedure is guided by three fundamental risk questions:

What might go wrong with the associated process? (risk identification)
What is the likelihood that this will go wrong? (risk analysis)
What are the consequences? How severe are they if this goes wrong? (risk analysis)

Conducting risk identification is real about understanding how complicated and complex the associated process is. This looks at the following criteria:

Interconnectedness: the organization and interaction of system components and other processes
Repeatability: the amount of variance in the process
Information content: the amount of information needed to interact with the process

What Happens During a Review of Process and Procedure

The review of a process/procedure ensures that the proposed changes add value to the process and attain the outcome the organization wants. There are three levels of review (which can and often do happen simultaneously):

Functional review
Expert review by subject matter experts
Step-by-step real-world challenge

Functional review is the vetting of the process/procedure. Process stakeholders, including functional area management affected by the change has the opportunity to review the draft, suggest changes and agree to move forward.

Functional review supplies the lowest degree of assurance. This review looks for potential impact of the change on the function – usually focused on responsibilities – but does not necessarily assures a critical review.

In the case of expert review, the SMEs will review the draft for both positive and negative elements. On the positive side, they will look for the best practices, value-adding steps, flexibility in light of changing demands, scalability in light of changing output targets, etc. On the negative side, they will look for bottlenecks in the process, duplication of effort, unnecessary tasks, non-value-adding steps, role ambiguities (i.e. several positions responsible for a task, or no one responsible for a task), etc.

Expert review provides a higher degree of assurance because it is a compilation of expert opinion and it is focused on the technical content of the procedure.

The real-world challenge tests the process/procedure’s applicability by challenging it step-by-step in as much as possible the actual conditions of use. Tis involves selecting seasoned employee(s) within the scope of the draft procedure – not necessarily a SME – and comparing the steps as drafted with the actual activities. It is important to ascertain if they align. It is equally important to consider evidence of resistance, repetition and human factor problems.

Sometimes it can be more appropriate to do the real-world test as a tabletop or simulation exercise.

As sufficient reviews are obtained, the comments received are incorporated, as appropriate. Significant changes incorporated during the review process may require the procedure be re-routed for review, and may require the need to add additional reviews.

Repeat as a iterative process as necessary.

The process/procedure lifecycle can be seen as the iterative design lifecycle.

Design Thinking: Determine process needs.

Collect and document business requirements
Map current-state processes.
Observe and interview process workers.
Design process to-be.

Startup: Create process documentation, workflows, and support materials. Review and described above

Continuous Improvement: Use the process; Collect, analyze, and report; Improve

2019 State of the Blog

I started this blog as an exercise in deliberate practice, as well as reflective. In order to grow it is important to engage in critical reflection, which requires a process of mutual learning, a consciously organised process of deliberative and distributed reflection. Which is what I strive to do in my blog posts.

At the end of last year, I evaluated my blog goals through an ACORN exercise, as well as updating a SWOT. These stand up pretty well, even in a year of changes where I took on member leader responsibilities as the chair of the ASQ’s Team and Workplace Excellence Forum and took a new job.

I met my posting goal, which was 1.5 posts a week, with 81 posts and 33.5k words.

The top 5 posts of 2019 are:

FDA signals – no such thing as a planned deviation: Written in 2018 this post directs a lot of traffic to the blog from search engines, and has the largest geographic spread. Key message here continues to be all temporary changes, all planned departures, need to go through a change control system of appropriate rigor based on the risk involved.
Risk Based Data Integrity Assessment: Data Integrity and Risk Management are two of my favorite topics and in this post I combine the two and provide a fairly usable tool. I wrote this post while at the ASQ’s Audit Conference, where I presented on data integrity.
Lessons Learned as a Developing Leader: I am very gratified that this piece of introspection was viewed as many times as it was. Three months into my current job and this post, and the followup, are a good roadmap.
Decision Quality: How we make decisions, deal with subjectivity and uncertainty and problem-solve are all big concerns for our organizations. This post serves as a good anchor for my thought and practice, as well as the direction of future endeavors.
Driving for Mature Quality Organizations – FDA recent perspective: Building a quality culture, driving maturity in our organizations are critical. The FDA is spot-on, and companies really need to be coming to grips and dealing with this systematically.

Looking ahead to 2020 for the blog, I am going to take a bit of direction from Luigi Sille who set the following goals for himself:

Build up my expertise
Grow my network
Continuously improve every single day

For building expertise, I want to continue to focus on building tools and methods to: deal with subjectivity and uncertainty around decision making and risk management; proactively build a culture of quality and excellence, especially dealing with aspects of data integrity; and, find connections between the larger organizational/leadership/operational bodies of work and adapt them to the quality profession.

This blog is a large part of growing my network and I want to get to 2 blog posts a week consistently. I’ll continue to work with the ASQ as chair of the Team and Workplace Excellence Forum, including holding at least 2 events (including an unconference!). I am also trying to pull together a group of speakers to bring data integrity and quality culture as a stream to ASQ BosCon. I’ll speak at least 2 ASQ Conferences. I’ll also deepen some ties with the PDA, including speaking at one conference.

As I continuously work to improve, I will bring the topics I’m learning and implementing back to this blog.

Four Types of Problems by Art Smalley

Four Types of Problems: from reactive troubleshooting to creative innovation by Art Smalley (2018, Lean Enterprise Institute, Inc. ) is a fascinating book focusing on dividing problem solving and innovation into four major types:

Troubleshooting: A reactive process of rapidly fixing abnormal conditions by returning things to immediately known standards. While beneficial in the immediate term this approach often fails to solve the problem’s root cause.
Gap-from-standard: A structured problem-solving process that aims more at the root cause through problem definition, goal setting, analysis, countermeasure implementation, checks, standards, and follow-up activities.
Target-state: Continuous improvement that goes beyond existing levels of performance to achieve new and better standards or conditions.
Open-ended and Innovation: Unrestricted pursuit through creativity and synthesis of a vision or ideal condition that entail radical improvements and unexpected products, processes, systems, or value for the customer beyond current levels.

Art Smalley is a well known Lean expert, and this book definitely grows out of the wisdom and is a pretty good read. He shares
the strengths and weakness of each problem solving technique providing many points of introspection, such as the questions at the end of each chapter and excellent illustrations.

This book provides s a framework, a mental model, to effectively approach and assess a situation in order to seek and bring the appropriate kind of thinking to calmly, confidently address the problem at hand.

In many ways this book was my favorite quality book of 2018. I think it could serve as a valuable primer and I’m contemplating how to use it for internal training this year.