Data Process Mapping

In a presentation on practical applications of data integrity for laboratories at the March 2019 MHRA Laboratories Symposium held in London, UK, MHRA Lead GCP and GLP Inspector Jason Wakelin-Smith highlighted the important role data process mapping plays in understanding these challenges and moving down the DI pathway.

He pointed out that understanding of processes and systems, which data maps facilitate, is a key theme in MHRA’s GxP data integrity guidance, finalized in March of 2018. The guidance is intended to be broadly applicable across the regulated practices, but excluding the medical device arena, which is regulated in Europe by third-party notified bodies.

IPQ. MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage

Data process maps look at the entire data life-cycle from creation through storage (covering key components of create, modify and delete) and include all operations with both paper and electronic records.   Data maps are cross-functional diagrams (swim-lanes) and have the following sections:

  • Prep/Input
  • Data Creation
  • Data Manipulation (include delete)
  • Data  Use
  • Data Storage

Use a standard symbol for paper record, computer data and process step.

For computer data denote (usually by color) the level of controls:

  • Fully aligned with Part 11 and Data Integrity guidances
  • Gaps in compliance but remediation plan in place (this includes places where paper is considered “true copy”
  • Not compliant, no remediation plan

Data operations are depicted utilizing arrows.  The following data operations are probably most common, and are recommended for consistency:

  • Data Entry – input of process, meta data (e.g. lot ID, operator)
  • Data Store – archival location
  • Data Copy – transcription from another system or paper, transfer of data from one system to another, printing (Indicate if it is a manual process).
  • Data Edit – calculations, processing, reviews, unit changes  (Indicate if it is a manual process)
  • Data Move – movement of paper or electronic records

Data operation arrows should denote (again by color) the current controls in place:

  • Technical Controls – Validated Automated Process
  • Operational Controls – Manual Process with Review/Verified/Witness Requirements
  • No Controls – Automated process that is not validated or Manual process with no Review/Verified/Witness Considerations
Example data map

AI/ML-Based SaMD Framework

The US Food and Drug Administration’s proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) is fascinating in what it exposes about the uncertainty around the near-term future of a lot of industry 4.0 initiatives in pharmaceuticals and medical devices.

While focused on medical devices, this proposal is interesting read for folks interested in applying machine learning and artificial intelligence to other regulated areas, such as manufacturing.

We are seeing is the early stages of consensus building around the concept of Good Machine Learning Practices (GMLP), the idea of applying quality system practices to the unique challenges of machine learning.

WCQI Day 4

Last day of the conference and for the first session I present on “Knowledge Enables Change.”

Similar to my BOSCON talk, which was the beta so I think I covered things better in this one.

Expand Your Impact on the Culture of Quality by Kathy Lyall

Solid focus on both external and internal signifiers of quality culture. A little basic but very worth reinforcing.

And then I left, skipping the last keynote to get to the airport.

Good conference this year. Overall I felt that many of my choices for sessions ended up being more basic than I thought, but there is a lot of value in that. I will hopefully make the time to turn my thoughts into better blog posts.

WCQI Day 3 – Afternoon

Afternoon Keynote – Cheryl Cran on NextMapping

Future of work thought leadership….People First, Digital Second

Digital second is an interesting keynote theme (2 out of 4) and I appreciate the discussion on equitable futures and moving companies away from autocracy. Not sure anyone who speaks at large corporations is really all that committed to the concept. And I didn’t feel much more than lip service to the concept in this keynote.

Stressing reverse mentoring is good, something that all of us need to be building the tools to do better. Building it into technology integration is good.

Basic sum-up is that Change Leadership Traits are:

  • Relational vs transactional
  • Focus on ‘people’ first
  • Highly adaptable to people
  • and situations
  • Coach approach
  • Creative solutions
  • Future focused
  • Transparent
  • Empowering

In short, any talk that thinks having a clip from “In Good Company” is a good idea for teaching agile thinking is problematic.

“Storytelling: The Forgotten Change Management Tool ” by Keith Houser

Storytelling is one of the critical jobs of a quality professional, and this was a great presentation. Another flip session with pre-work that a lot of folks didn’t do.

I’m going to let Keith’s template speak for itself: https://www.eventscribe.com/2019/ASQ-World/flipSessions.asp?h=Full%20Schedule&BCFO2=FL

This was marked basic. And unlike a lot of stuff marked intermediate this felt like truly a best practice, pushing the envelope in many ways. Sure I apply these principles, but the discipline here is impressive.

WCQI Day 3 – morning

I didn’t make it to the key note. I had a work conference call so I will never learn the quality secrets of Anheuser-Busch.

“A Fresh Approach to Risk Assessment & FMEA: It’s all about severity” by Beverly Daniels.

After yesterday’s Quality 4.0 session I was not going to miss this as the presenter has a blunt, to the point attitutde, that could be interesting and fun to watch.

Very R&R driven mindset, which is a little far away for me but one I find fascinating. Her approach is to get rid of probability and detection on an FMEA. How does she do that?

  • Create a function diagram and process maps as applicable
  • Create an input:output matrix
  • List functions
  • List failure modes: how a failure presents itself
  • List the effects of the failure modes
  • Determine severity of the failure modes at the local level and system level
  • Develop V&V, mitigation and control plans for all high severity failures.

Which means she’s just not using the risk assessment as a consolidation of decisions (hopefully using some other form of matrix) and always uses  testing data for occurrence.

The speaker made the point about static FMEA’s a lot, I’m a big fan of living risk assessments, and I think that is an approach that needs more attention.

Some interesting ideas on probability and testing here, but buried under some strong rhetoric. Luckily she posted a longer write-up which I’ll need to consider more.

“Using Decision Analysis to Improve, Make or Break Decisions” by Kurt Stuke

Someday I’ll write-up more on why I find long credential porn intros annoying. My favorite intro is “Jeremiah Genest works for Sanofi and has 20 years of experience in quality.” Post my damn CV if you want, but seriously my words, my presentation and my references should speak for themselves.

I like the flip sessions, prepping prior is always good. The conference needs to do a better job letting people know about the prep work. The amount of confusion in this session was telling. The app does not even link to the prep work, only way is an email.

Here are Kurt’s resources: https://www.kurtstuke.com/OER/WCQI/

There is no 100% tool, glad he stresses that at the beginning, as we sometimes forget to do that in the profession.

“Whim leads to advocacy approach which means data looses its voice.”

Used KT as a way for decision analysis. Talking about the “must haves” and “nice-to-haves” Maybe it’s because of the proprietary nature of KT, but I feel their methodology is either someone folks are really familiar with or surprised by.

So this is again basic stuff. I’m not sure if this is what I am deciding to go to or if just where I am in my journey. At my table I was the only one really familiar with these tools.

Good presenter. Love the workshop approach. It was great watching and participating with my table-mates and seeing lightbulbs go off. However, this is a basic workshop and not intermediate.