Quality Culture

Before we can understand quality culture, we must first ask ourselves “what is quality?”.

When YOU, the reader, think of quality, what comes to mind?

The fact is, the answer to this question isn’t that straightforward, and is debated even today by quality experts all over the world. In reality, quality is contextual and the meaning can vary according to the situation. Sometimes quality is a feeling rather than a definition. If you’re a Responsible Person, Quality Manager, or member of a quality team who regularly conducts third party audits, you can generally get an impression or a “feeling” of an auditee’s quality system within the first half-hour of beginning the audit.

ISO 9001:2015 defines quality as:

“The quality of an organisation’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties”.

Another definition, and one I much prefer, was coined by David Hutchins in his 2019 book “Quality Beyond Borders”:

“Quality is the sparkle that separates the best from the rest”.

It’s true. This is why we buy the “good” wine for special occasions and Aldi special for a Friday night.

This principle can be applied and “felt” within organisations and good quality can make a business whereas bad quality can destroy it.

Quality affects all corners of a business and should be incorporated as part of the overall work culture. Quality shouldn’t be boxed off inside the “quality department” or a lone quality manager. Think of it this way; your quality management staff should be there to oversee and mentor, monitoring inputs and outputs of the quality management system and leading the organisation towards the best standard of quality achievable.

To put this in a working context, let’s use root cause analysis (RCA) as an example exercise. As consultants, we see a lot of RCA being performed solely within the quality department with little input from the operational teams involved in the actual investigated process. Whilst quality might be “experts” on RCA, they’re NOT experts in that operational process and unless we involve the process “experts” in the exercise, how can we truly identify where the process has failed?

Now imagine your operational experts are also trained on root cause analysis and continuous improvement strategies, how much more effective will the investigation outcome be? Of course, quality staff will need to monitor the overall deviation process however the end result is much more powerful. Who better to investigate and improve a process than those people performing that job multiple times a day?

Organisations operating an effective quality culture generally have the following features in common:

• A well integrated Quality Management System.
• Processes that are well defined and understood by all staff.
• Company values and objectives
• A level of understanding of quality throughout the entire organisation and it’s importance in achieving company objectives.
• Utilisation of staff knowledge and expertise at all levels.
• Excellent change management implementation.
• A happy and well motivated work-force.

Good Distribution Practice relies on all staff within an organisation to maintain compliance to regulatory requirements and guidelines. The culture should promote patient safety as a priority, with product quality sitting at the heart of the operation.

Well defined quality and handling processes that are understood, followed and accessible to all staff form an integral part of the overall quality management system, and a focus on continuous improvement at all levels is important to maintaining the conditions for which a wholesale distribution authorisation has been granted.

An important question that Licence Holders should ask themselves is “how much value does our quality management system bring to our organisation?”. Not just commercial value, but in terms of efficiency, productivity, patient safety and risk identification/mitigation.

SOP’s and quality documentation shouldn’t exist for the purpose of inspection, but to provide direction, information and consistently drive continuous improvement within all departments of an organisation. A great side effect of a top-tier quality culture is a huge reduction in quality related costs such as waste (both physical and resource) and maximum efficiency output.

Going back to the first chapter of this blog, we spoke about that “feeling” or “impression” you get of a company within thirty minutes of conducting an audit. That’s the culture of quality you’re picking up on. A well integrated quality system with clear leadership driving all staff towards a strong quality culture is magnificent, and so is the compliance status.

Changing a quality culture within an organisation is a big ship to turn around, however it is possible. Not only possible, but achievable with the right mind-set and leadership commitment. Culture must come from the top down, and quality begins with the Licence Holder. The change won’t happen overnight, but you will notice it happening both in quality outputs and the bottom line. There are multiple strategies and methods that can be deployed within an organisation to become “the best in class” and pump quality throughout all departments, even… operations.

By Jenna Cordery @ Paradigm Shift Consulting

Assistance and Support

If you’d like to discuss how we can further develop your culture, compliance or provide training, get in touch on 0330 133 0920