Understanding Policies

The article “Research: Do New Hires Really Understand Your Policies?” by Rachel Schlund and Vanessa Bohns in HBR does a great job discussing consent that I think have real ramifications on GMP training, especially of the read-and-understood variety. Really gets me thinking on GxP orientation and the building of informed consent.

GxP New Hire Orientation

Building Effective Consent

1. Transparent Communication

Provide clear, detailed information about the why’s.

2. Staged Introduction

Instead of overwhelming new hires with all that GxP training at once, introduce them gradually over time. This approach gives employees the opportunity to digest and comprehend each requirement individually.

3. Interactive Training Sessions

Conduct engaging training sessions that explain the rationale behind each major requirement set and allow employees to ask questions and voice concerns.

4. Regular Policy Reviews

Implement periodic reviews with employees to ensure ongoing understanding and address any evolving concerns or questions.

5. Clear Benefits Communication

Explain the benefits of each requirement to the employee and the organization, helping new hires understand the value and purpose behind the requirements.

Adapting and Experimenting – the Role of a New Quality Leader

I think a common challenge is how do we as a new quality professional joining an organization replicate the same success we have had in past roles

Quality requires a support structure, and I think it is easy to underestimate the impact of the absence, or the lack of, that structure. Just parachuting quality professionals into different organizations where they are left without the scaffolding they’ve implicitly grown to expect and depend on can lead to underperformance. Some adapt, of course, but others flounder, especially when hired with daunting short-term expectations, which can often be the case in organizations looking to remediate gaps in a fast way. I think this is only exacerbated as a result of the pandemic.

Culture can have a steep learning curve and being able to execute requires being very well-versed in the culture of an organization. You have to know how your organization works in order to get it to work diligently like a well-oiled machine to execute the higher-level quality vision.

Learning the culture doesn’t mean simply parroting the oft-repeated mantras received during orientation, but truly internalizing it to an extent where it informs every small decision and discussion. At the best of times, that’s difficult and takes time, particularly as there isn’t usually a single monolithic culture to learn, but myriad microcultures in various different parts of the organization. Doesn’t matter the size, this is a challenge.

In the worst case, where an organization has a culture diametrically opposite to that of the previous workplace, “learning the culture” also requires un-learning almost everything that led people to get to their current level in the first place. The humility to strive to turn themselves into the leader the organization truly needs, rather than the leader they’ve grown to be over the past years, is a hard one for many of us. Especially since we are usually brought on board to build and remediate and address deficiencies.

To be a successful agent of change one has to adapt to the current culture, try experiments to accelerate change, and do all the other aspects of our job.

This is hard stuff, and a part of the job I don’t think gets discussed enough.

GxP New Hire Orientation

Leveraging the company’s new employee orientation program can help both compliance and quality by ensuring that a new hire (or transfer) understands the expectations for employee performance which:

Are covered by the GxP regulations, corporate policies and process/procedure
Are written and readily available to employees
Are mandatory

In a heavily regulated industry, like pharmaceuticals, this is especially important because an individual may not have experienced such regulation in their former position. Even within a regulated organization the level of regulatory experience will change as you move from one area to the next.

The new hire orientation process is not a once-and-done and should be long enough to truly make an impact on the individual’s performance.

This new hire program is seeing to engage new hires more rapidly within the quality culture to ensure that employee’s behavior aligns more rapidly with quality culture.

For example, the new hire orientation should reinforce that a pharmaceutical company is a regulated environment, responsible for products that can directly affect customers’ health and quality of life. Product failure could result in death or sickness. Working for an organization where products help preserve and sustain life comes with the responsibility to know one’s job and perform it correctly at all time.

New hire orientation must present the organization’s cultural imperative for quality – why is it important to fulfill the organization’s purpose or reason for being – and how has this been embedded into the organization’s culture. At heart new hire orientation should answer three questions:

What does quality mean to you personally and how do you exhibit in the organization?
What are the expectations for quality outcomes in the organization and how we judge that they have been met.
How quality is embedded in the culture and daily work of the people in this organization and what represents good role model behaviors.

Content that does not immediately impact the new hire, or only impacts new hires in several departments or units, is better deferred until later training activities.

Topics that would be in that immediate review include:

What does it mean to work in a regulated environment
The role of the quality system
How to access process/procedure and complete training
Good documentation practices and data integrity (high level)
How to engage with regulatory stakeholders and other external partners (high level)

What other material would you cover?