2018 in review – year 1

I started this blog 8 months ago as a way to think aloud about items that were interesting to me and causing me to think about my profession.

The five most popular posts tell me that at least some folks who read this blog do so because they too are interested in similar topics:

Looking back at my SWOT, I can see that it was a very useful tool for charting where this blog would take me. Change, risk, data, quality culture, knowledge management. All the items I spent time thinking about are there. I hope folks go as much use out of my thinking aloud as I did.

In the next few weeks I’ll be trying to utilize a few quality tools to lay out my goals for both this blog and my other professional endeavors in 2019.

As you wrap up 2018 and look forward to 2019, what quality matters are important to you?

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?

What Closing A Government Radio Station Would Mean For Your Clocks – Start contingency planning

Many clocks sync with a government radio station that’s been proposed to be closed. Scott Simon talks with Thomas Witherspoon of the website The SWLing Post.
— Read on www.npr.org/2018/08/25/641835302/what-closing-a-government-radio-station-would-mean-for-your-clocks

NIST’s full Fiscal Year (FY) 2019 budget request to Congress calls for the agency to “discontinue the dissemination of the US time and frequency via the NIST radio stations in Hawaii and Fort Collins, Colorado.” The agency noted, “These radio stations transmit signals that are used to synchronize consumer electronic products like wall clocks, clock radios, and wristwatches, and may be used in other applications like appliances, cameras, and irrigation controllers.” The specific cut, which would come from the NIST Fundamental Measurement, Quantum Science, and Measurement Dissemination budget, would amount to $6.3 million.

This is the type of thing to add to your SWOTs and other risk management/contingency planning activities. I, too, would like to have confidence it will not be in the final bill, but now is the time to take appropriate actions for your organization.

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