Personal Audits as part of team building for Projects

The personal audit is a tool used in change and project management (and such) to help team members and sponsors judge their strengths and weaknesses with respect to change leadership. It illustrates some skills from the full range necessary to introduce change into an organization.

This exercise is great to do at the beginning of the project, where it can help team members begin to understand some of the human issues applicable to all projects. As one mentor once told me – If this exercise strikes team members as inapplicable, then they really need to do it.

Domain What I do Well What I Need to Work On
Manage Attention: To what extent do I manage my time, energy, passion, focus and agenda?    
Adopt change roles? How much attention do I pay to smatters like: Creating a need, Shaping a vision, Mobilizing commitment,  Monitoring progress, Finishing the job,  Anchoring the change)    
Technical competence: To what extent to I demonstrate competence in technical abilities?    
Interpersonal competence: how skilled am I at interacting with others?    
Vision: How well can I articulate the desired outcome of the project and the benefits to others?    
Teamwork: How often do I recognize good work done by teammates?    
Diplomacy: How closely am I working with all the groups affected by this project?    
Conflict management: Can I deal with disagreement without avoiding it or blowing up?    
Summary: Overall strengths and weaknesses    

An Analysis Of FDA FY2018 Drug GMP Warning Letters

BioProcess Online has a nice summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013.
— Read on www.bioprocessonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003

Data Integrity definitely continues to be a theme, and I agree that we are seeing a growing trend around process validation. I also think root cause investigations was a theme of 2018 that we are going to be seeing a lot more of.

FDA draft guidance – Continuous Manufacturing

The FDA published today a new draft guidance “Quality Considerations for Continuous Manufacturing Guidance for Industry.” Which, together with ICH plans continues to demonstrate the emphasis on continuous manufacturing.

More a set of questions than anything else, this is a good document for those who are grappling with the challenges of continuous manufacturing.

FDA launching pilot program on established conditions

The FDA has announced a pilot program to “propose explicit established conditions (ECs) as part of an original new drug application (NDA),
abbreviated new drug application (ANDA), biologics license application
(BLA), or as a prior approval supplement (PAS) to any of these.”

As the FDA mentioned, this is a followup of two draft guidances: The 2015 FDA ‘‘Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products’’and the draft Q12.

It is exciting to see Q12 move forward. We can argue about its imperfections, but at the end of the day this is a big step for the industry.

The role of a data steward

With data integrity on everyone’s mind the last few years, the role of a data steward is being more and more discussed. Putting aside my amusement on the proliferation of stewards and champions across our quality systems, the idea of data stewards is a good one.

Data steward is someone from the business who handle master data. It is not an IT role, as a good data steward will truly be invested in how the data is being used, managed and groomed. The data steward is responsible and accountable for how data enters the system and ensure it adds value to the process.

The job revolves around, but is not limited to, the following questions:

  • Why is this particular data important to the organization?
  • How long should the particular records (data) be stored or kept?
  • Measurements to improve the quality of that analysis

Data stewards do this by providing:

  • Operational Oversight by overseeing the life cycle through defining and implementing policies and procedures for the day-to-day operational and administrative management of systems and data — including the intake, storage, processing, and transmission of data to internal and external systems. They are accountable to define and document data and terminology in a relevant glossary. This includes ensuring that each critical data element has a clear definition and is still in use.
  • Data quality, including evaluation and root cause analysis
  • Risk management, including retention, archival, and disposal requirements and ensuring compliance with internal policy and regulations.

With systems being made up of people, process and technology, the line between data steward and system owner is pretty vague. When a technology is linked to a single system or process it makes sense for them to be the same person (or team), for example a document management system. However, most technology platforms are across multiple systems or processes (for example an ERP or Quality Management System) and it is critical to look at the technology holistically as the data steward. I think we are all familiar with the problems that can be created by the same piece of data being treated differently between workflows in a technology platform.

As organizations evolve their data governance I think we will see the role of the data steward become more and more part of the standard quality toolbox, as the competencies are pretty similar.