Data Integrity Thoughts

At the MHRA Blog, a GDP Inspector has posted some thoughts on Data Integrity. As always, it is valuable to read what an agency, or a representative, of an agency in this case, is thinking.

The post starts with a very good point, that I think needs to be continually reiterated. Data Integrity is not new, it is just an evolution of the best practices.

Data Integrity

It is good to see a focus on data integrity from this perspective. Too often we see a focus on the GCP and GMP side, so bringing distribution into the discussion should remind everyone that:

  • Data Integrity oversight and governance is inclusive of;
    • All aspects of the product lifecycle
    • All aspects of the GxP regulated data lifecycle, which begins at the time of creation to the point of use and extends throughout its storage (retention), archival, retrieval, and eventual disposal.

Posts like this should also remind folks that data integrity is still an evolving topic, and we should expect more guidance from the agencies from this in the near future. Make sure you are keeping data integrity in your sites and have a process in place to evaluate and improve.

I recommend starting at the beginning, analyzing the health of your current program and doing a SWOT.

data integrity SWOT

 

 

 

Value of the ASQ

If I were to ask a hundred of my peers “How did you get into quality,” I would probably hear 100 different stories (with of course some commonalities). And yet, quality is definitely a distinct set of expertise and practice.

When I try to describe my job, I often find myself breaking down what I do into categories (I’m a project manager, a trainer, a problem solver, risk manager, a facilitator, a puzzle solver, a detective, etc). some of these are professional paths on their own, others not so much.

It is for this reason that I am a huge fan of the ASQ’s Quality Body of Knowledge, as it does a good job of uniting what we do. Sure, it’s not perfect but it is an excellent framework to build an understanding of just what a quality professional can bring to the table, as well as great development path.

One of the many things I love about this is the ability to learn from folks no matter what their industry. This cross-pollination is vital to innovation. And having the QBOK there gives a framework for common discussions.

With the QBOK goes a technical knowledge bolt-on. For example, in my case pharmaceuticals (strong) and medical devices (average).

The ASQ certification board I believe gets it wrong by calling these specific technical certifications “Leadership.” There is nothing leadership centric by getting the CPGP, for example.

I think we’re better breaking these certifications into QBOK core (e.g. quality improvement associate, quality process analyst, manager of quality), specific skills (e.g. six sigma, haccp, quality auditor, reliability and calibration) and then industry specific (e.g. CPGP, biomedical auditor)

As the ASQ goes through its current transformation, I hope the leadership and members remember the strength of the QBOK, work to enshrine it in everything the organization does, and continues to refine it. This is the value of my ASQ membership.

 

Training assessment as part of change management

One of the key parts of any change (process improvement, project, etc) is preparing people to actually do the work effectively. Every change needs to train.

Building valid and reliable training at the right level for the change is critical. Training is valid when it is tied to the requirements of the job – the objectives; and when it includes evaluations that are linked to the skills and knowledge started in the objectives. Reliability means that the training clearly differentiates between those who can perform the task and those who cannot.

A lot of changes default to read-and-understand training. This quite bluntly is the bane of valid and reliable training with about zero value and would be removed from our toolkit if I had my way.

There are a lot of training models, but I hold there is no single or best method. The most effective and efficient combination of methods should be chosen depending on the training material to be covered and the specific needs of the target group.

For my purposes I’ll draw from Edgar Dale’s Cone of Experience, which incorporates several theories related to instructional design and learning processes. Dale theorized that learner’s retain more information on what they “do” as opposed to what is “heard,” “read” or “observed.” This is often called experiential or action learning.

dalescone

Based on this understanding we can break the training types down. For example:

  • Structured discussions are Verbal and some Visual
  • Computer Based Trainings are mostly Records
  • Instructor Led Trainings are a lot about Demonstration
  • On-the-job training is all about the Experience

Once we have our agreed upon training methods and understand what makes them a good training we can then determine what criteria of a change leads to the best outcome for training. Some example criteria include:

  • Is a change in knowledge or skills needed to execute the procedure?
  • Is the process or change complex? Are there multiple changes?
  • Criticality of Process and risk of performance error? What is the difficulty in detecting errors?
  • What is the identified audience (e.g., location, size, department, single site vs. multiple sites)?
  • Is the goal to change workers‘ conditioned behavior

This sort of questioning gets us to risk based thinking. We are determining where the biggest bang from our training is.

Building training is a different set of skills. I keep threatening a training peer with doing a podcast episode (probably more than one) on the subject (do I really want to do podcasts?).

The last thing I want to leave you is build training evaluations into this. Kilpatrick’s model is a favorite – Level 4 Results evaluations which tell us how effective our training was overtime actually makes a darn good effectiveness review. I strongly recommend building that into a change management process.

Gamestorming

Gamestorming: A Playbook for Innovators, Rulebreakers, and Changemakers by Dave Gray, Sunni Brown, and James Macanufo

Like The Quality Toolbox, this is a book chock-full of usefulness. This book provides a fun approach that makes it possible for collaborative activities to get everyone participating in creative and design-oriented activities. From planning meeting, generating ideas, understanding customers, creating prototypes, or making better decisions, Gamestorming is a way for groups to “work better together.”

Divided into Opening, Exploring and Closing sections, the structure of the book will be familiar to anyone with a facilitation background. I am constantly dipping into this book for activities for team meetings, project kickoffs, development meetings, lessons learned and a whole lot of other meetings.

This book delves into the usage of visual thinking to increase effectiveness and I find dramatically shorten the length of time needed for a group to solve a problem. This book proposes that visual thinking can:

  • Using a simple, shared visual language to increase understanding and information retention;
  • Applying improvisational discovery to keep participants engaged;
  • Mapping the big picture, solving problems and innovating as a team;
  • Creating visual meeting artifacts to drive decisions forward.

What is especially cool is that there is a great webpage dedicated to these games that I hope you will find as useful as I do. It is full of exercises, activities and advice.

 

Every change is a project, every project is a change

Project Management, the structured approach for managing tasks, resources, and budget to achieve a defined deliverable, is an important part of the quality management toolbox, and an important aspect to build into your change management program.

There are a lot of project management methodologies, but they all boil down to having an understanding of the tradeoffs between time, cost, and scope of a change; and then motivating a team towards delivering the change.

project and change comparison

Evaluate is best seen as a gate at the end of the project’s design (or a phase of design). A well-designed project, with appropriate stakeholders and team members ideally will flow nicely into an evaluate change control (or set of change controls). Having this as part of your gate to develop will ensure that the right subject-matter-experts have been involved, that all potential risks and impacts are understood, and will ensure the site is ready to implement.

Small projects and the change management lifecycle are usually one and the same.

For projects with large impact, it is often important to create more than one change control, to ensure appropriate implementations. In these cases it is often useful to create a change strategy (or incorporate in a project deliverable, such as a gate document) which can include:

Scope Describe the project, indicating the current and future state.
Roles/ Responsibilities Indicate what functions/departments will serve what role in the change controls

Indicate the role and responsibilities of project management.

Methodology/ Strategy What activities are included and how they will be organized.

How many change controls will be created as part of this strategy.

How change controls will be organized and linked together (e.g. dependencies).

Provide a methodology for managing changes and ensuring all change control activities happen according to the provided timetable.

Things to Consider:

Are there other changes that affect the same room/area or equipment?

How are affected rooms/areas/equipment being taken out of and placed back into service as to not to interfere with provided timetable?

Will these change controls effect daily operations/sampling?

How will changes be organized? For example will changes be organized along install, validate and implement?

If multiple areas are to be effected, will there be changes in Material and Personnel Flow that will need to be modified to execute the multiple changes?

Effectiveness Review If the project will have one effectiveness review (e.g. a process validation, comparability protocol, stability study) indicate, provide the effectiveness review criteria and justify. Provide a timeline for completion of the effectiveness review.
Regulatory Strategy Regulatory strategy for filing the project (e.g. will changes be filed independently or together, at what point, which changes will require regulatory assessment)
Planned Timetable Timelines for writing, approving, implementing and closing change controls.

Take the dependencies written in the Methodology/Strategy into consideration when developing the timetable

Closure Plan How will the strategy be closed? What are the criteria for a successful project closure?

For larger projects, the change evaluation will start in the project design phase but can continue through implementation as individual changes are put in place.

The advantage of writing this strategy allows the project to consolidate deliverables and ensure the right level of effort is put into the changes across the project.

The Quality Toolbox

The Quality Toolbox by Nancy Tague is such a useful book that it belongs on everyone’s bookshelf.   Tools are included for generating and organizing ideas, evaluating ideas, analyzing processes, determining root causes, planning, and basic data-handling and statistics. From the seven basic quality tools to a wide variety of more sophisticated tools, this my first go-to when I am trying to figure out the best tool for a task, each  getting a solid write-up that can propel you into use.

The core spine of the book is a matrix that helps find the right tool base don three questions:

  1. What do you want to do with the tool (project planning, idea creation, process analysis, data collection and analysis, cause analysis and decision making)
  2. Where you are in process improvement methodology
  3. Whether you need to expand or focus thinking

Each tool gets a solid treatment, with examples and templates so it can be put into use.

Quality professionals tend to acquire a resources on specific tools. This book serves to easily consolidate tools, help you identify the right tool to use, and will probably also introduce you to a bunch of new tools.

Regulatory Impact of Changes

In a regulated industry, such as pharmaceuticals or medical devices, knowing your changes impact your regulatory partners is a critical aspect of change management. For example, the MHRA in their yearly summarizations of GMP inspection deficiencies consistently cites failure to perform adequate review of need of regulatory notification (for example, see 2016 trends). And to be frank, we in the industry are often looking for more guidance, which drives responses like ICHQ12 and the FDA’s March 2018 draft guidance CMC Changes to an Approved Application: Certain Biological Products and all the other similar guidances out there.

These all follow a similar risk-based approach, and this approach should be built into your change management system (and applicable change control process).

regulatory structure2

The major difference between Supportive Information and Do-and-Record is usually what goes in your product quality report (APR/PQR). Fro example, I often see qualification of facility fit into the Do-and-Record area. These changes may not be fillable, but you certainly want to review and account for.

Many companies manage this through their regulatory affairs organization, but that can be time consuming. It is better to take the time to identify the supportive and do-and-record categories out front, thus removing the need for an extra assessment. The PQR review process is a great tool for ensuring consistent execution.

This risk based approach should look at the dossiers, taking into account any special market considerations, as well as current best practices in the regulations. For those companies lucky enough to be more towards the QbD model, established conditions will greatly help here.

Then build a matrix to help guide your changes. An example could include items like these:

Facility, Equipment, Manufacturing Systems, Utilities & Automation Equipment/instrument maintenance
Decommissioning of equipment not classified as critical equipment
Computer programming that affects non-production equipment
Alarms (i.e., notification system for out of tolerances)
Cleaning and Sanitization of Manufacturing facilities and non-product Contact equipment
Upgrade of Application Software or operating system
Alarm setpoint changes
Creating user groups and modifying user group privileges
Tuning parameter, adjustment to the gain, reset and rate of a PID controller
Manufacturing Processes In-process labeling
Changes to Process Control and Operating Parameters (tightening/shifting) within current non-established conditions
Change in equipment sterilization times
The addition of in-process or final product samples
Changes to sample volume for in-process or finished product samples
Addition of new ancillary equipment (e.g. no product contact, does not control process steps) to the process

You can then further delineate between Supportive Information and Do-and-Record on a few other criteria, such as qualification/validation impact.

Like many areas of good system management, this is an area where a forethought and design can reap dividends in making your changes more nimble while preventing a compliance mishap. Tapping into the PQR makes all this part of your knowledge management system, and allows you to grow as your needs grow. This is definitely not a once-and-done process.