October Highlight - The hidden factory impacting regulatory compliance & quality.

The pharmaceutical, life science and medical device industry is a rewarding, dynamic yet challenging sector to be in. While it is exciting and motivating to be able to bring new treatments, medicines and devices to help patients, the regulatory compliance activities can prove daunting. The challenges are further amplified by supply chain, workforce, productivity, political, and geographical issues. Organisations need to be agile, flexible, as well as profitable all the while ensuring they do not compromise patient safety. But this is often easier said than done. This month, I aim to shed light on a little known element of an organisation that can have a great impact on both compliance and productivity - the Hidden Factory.

The Hidden Factory

I was introduced to the concept of a"Hidden Factory" by lean expert Paul Dunlop and ever since I have been reflecting on it. The hidden factory is a Six Sigma/lean concept and is well known within other manufacturing sectors.

So, what is a hidden factory? According to Six Sigma, it is the hidden world of waste and flaws that slows down production and lowers the quality of goods. Consider this like an iceberg - the tip of the iceberg are all the known and established procedures, workflows and controls that an organisation has implemented. The lower part of the iceberg, which is hidden from view, is the hidden factory. It is these hidden elements that have a greater impact on efficiencies and for the regulated industry, on compliance.

As an organisation operating within strict regulatory guidelines, companies will implement QMS elements such as SOPs, training, validation, deviation and CAPA management, change management, GMP compliant facilities, equipment etc (the tip of the iceberg). While establishing these elements ticks the initial regulatory approval box, their effectiveness and continued compliance remains a challenge. And the organisation's hidden factory may be the root cause of this.

Below is an image that depicts the factors that constitute a hidden factory. While the image groups these elements under lost time, for the life science and pharmaceutical industry, they also have an impact on compliance and product quality.

Whether you are an early stage drug development company, a medical device startup, CMO/CDMO, a CRO or a traditional manufacturer, some or all the elements of a hidden factory are part of your organisation and impacting its productivity and compliance.

Let us understand some of the root causes that contribute to the hidden factory elements common within the regulated industry.

1. Ineffective SOPs - SOPs and work instructions when written with just compliance in mind, are often difficult to follow. Often SOPs as written do not reflect the real situation /environment in which the task is been performed. This leads to operators finding a workaround to get activities completed, leading to potential errors and non-compliances. Ambiguity and lack of clarity in SOPs leads to users making decisions on the go that can have potential critical impact on the quality of products.
2. Complex workflows - Often pharmaceutical companies create very complex workflows to execute a single process. The workflow may involve generation of multiple documents, require multiple approvers, manual interventions, multiple reviews, duplicate data entries etc. Many of these steps are introduced into the workflow in response to deviations, audit observations or due to old, manual legacy systems. Such complicated and convoluted workflows result in delays, data integrity and data transcription errors, wastage of resources and loss of productivity.
3. Lack of Governance Documents - Governance documents are high level documents that an organisation's senior management team establish to outline and define the company's approach towards managing their key business and regulatory obligations. All operations SOPs, work instructions, controls, processes and systems are created based on these governance documents. Most regulated industries create a quality manual or a site master file to comply with regulations but pay little attention to drafting clear, business tailored governance documents. A lack of good governance documents, especially around data, documents, safety and business continuity impact the ability of the organisation to respond rapidly to change. Further data integrity non-compliances increase as the organisation has no clarity on its data flows and controls.
4. Training- This is a topic that is most overlooked in the pharmaceutical/life science industry. Training is often a one-size fits all approach that does not take into account an individual's key roles, technical and soft skill requirements to execute their responsibilities as well as their learning styles. As a result, learning happens through trial and error, word of mouth and remains ineffective. Ineffective training programs are a major cause of human errors, underutilisation of resources and employee turnover.

While many of the hidden factory elements such as repetitive tasks, manual activities, data entries, inventory management, SOP drafting etc., can be addressed through the use of digital tools and automation, what is important to remember is that the effectiveness of these tools is still reliant on the organisation's in depth understanding of its business operations and regulatory obligations, assessment of the true root cause of these contributing factors and most importantly - culture.

Reflection for the month of October

In the next management review meeting, include a discussion on some of the hidden elements that are impacting compliance and quality within your organisation, on the agenda.

Tip - Ask employees to provide feedback on what they find the most frustrating in the organisation and what they do it overcome it. This is your hidden factory. You maybe surprised by the answers!!

Through my "Customise-Simplify-Comply" framework, I help the pharmaceutical and life science organisations identify their hidden factory and implement actions to address the impact. If you are interested, pls email me on [email protected] for a chat.

#qualitymanagementsystems #sixsigma #compliance #gmp #pharmaceuticalmanufacturing #medicaldevices #lifesciences #biotech #cdmo #cro #qualityassurance #training #automation #digital