ZenQMS Blog » Quality-compliance
Timothy Reinhardt
By Timothy Reinhardt on November 17, 2020

Shifts in the landscape of quality management training

When I started in the pharmaceutical industry nearly thirty years ago, training meant collecting large numbers of various staff members into a conference room on a slow day and methodically walking through a high-level general presentation packed with incidental information. This exercise was repeated annually for my first three years, with what seemed to me to only contain tiny alterations to the training material. Proficiency, engagement, and creativity were not a driving factor in the sessions. It seemed more about filling an afternoon and checking a box.
Mike Kent
By Mike Kent
on November 12, 2020

Tenth grade. High school. Speech class. Six words that, to most of us, including me, bring back various thoughts and emotions. Maybe one of those emotions is “fear”? But what if I told you that back then, and still today, you and I both have everything we need to be able to speak in front of a group of a thousand strangers? We are able to manipulate our mouth and breath in such a way as to generate words in a certain language.

But is “ability” or “competency” the desired outcome? 

Jen Rajchel
By Jen Rajchel
on August 10, 2020

Actionable insights, confidence in completed tasks, and clear context are key to managing quality, so we're excited to share with you how our 2020.2 release can help. 

Celia Brown
By Celia Brown
on February 17, 2020

Regulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies. 

Panos Boudouvas
By Panos Boudouvas
on August 20, 2019

I am frequently in meetings with quality leaders and regulatory experts where I find myself wishing I could share some part of the conversation or findings with a broader audience.  Something about the current state of affairs, best practice or just a really eloquent description of a pain point and how they are managing.  

Celia Brown
By Celia Brown
on June 11, 2019

Pressures are increasingly mounting for life science companies from multiple directions- customers, internal business stakeholders,  and regulators.  Quality leaders need to keep up with the latest regulatory updates in the life sciences industry and simultaneously scale and automate internal compliance and document control processes.

By Jeff Thomas
on April 26, 2016

Trouble with your Training Matrix?

Pharmaceutical companies use large training matrices to track employee's proficiency on SOPs, manufacturing processes, quality controls, and product reviews. When these training matrices are out of order, inefficient for employees, and do not deliver the right information to management, they cause multiple problems.

These seven problems are symptoms that your company's system needs to be updated and upgraded in order to maintain high quality product delivery. How many of these signs does your organization suffer from?

1. Human Entry Errors

Trouble with a training matrix occurs when people enter information regarding SOP training, or in the entry of other information they should have been trained on. Statistically predictable variations in quality information are almost always a result of management systems.

By Jeff Thomas
on April 07, 2016

According to the Journal of Pharmacy, the average pharmaceutical company has 1250 Standard Operating Procedures (SOPs) and over 150 employees. This makes a typical Excel training matrix responsible for at least 187,500 combinations of training (1250 x 150). These combinations do not account for tracking revisions of SOPs, managing relationships between different offices, or integrating research and development with SOP updates. 

Maintaining a non-validated Training matrix at even a fraction of that size is a prime area to fail an audit or fall out of compliance. Good Quality Management Systems (QMS) reduce the time

By Jeff Thomas
on March 15, 2016

 

Perhaps the biggest challenge facing a quality management team today, especially in the Life Sciences, is how to comply with regulations and take advantage of new cost-saving opportunities when the regulatory environment is fluid.

Maybe it’s time to do some Monday morning quarterbacking to see how your quality management system can grab every opportunity to regain possession of the ball. You may find that the true cost of your paper-based quality management system is ready for a game-changer.