Management Responsibility for Compliance & Operational Excellence

Spotlight

In last month's newsletter, I had written about how compliance and operational excellence need to go hand in hand if any organisation wants to improve its quality maturity levels. Management commitment to quality is one of the 5 practice areas that demonstrates quality maturity levels. This month I am going to shed some light on what management commitment & responsibility looks like in practice.

The phrase Management Responsibility, Management commitment to quality are referenced in every regulatory guidance documents & is increasingly become an area of focus by the regulators. Though there are slight differences in the way senior management's responsibilities are defined across different regulations, they all include the following elements:

• Management's commitment toward quality at all levels
• Define quality policy & objectives that are aligned to business strategy
• Ensure the design, implementation & improvement of an effective Pharmaceutical Quality System (PQS)
• Determine & provide adequate and appropriate resources to implement & maintain the PQS
• Ensure appropriate communication processes are established & implemented within the organisation
• Periodically review implemented PQS for its continuing suitability and effectiveness
• Establish adequate control & systems for managing outsourcing activities & purchased materials

Whether you are a senior management member of a startup, CDMO or commercial manufacturer, the above elements apply. Implementing systems & procedures for management review not only helps achieve compliance but, if done properly, it can help improve productivity & efficiency across the organisation.

But fulfilling this requirement can seem overwhelming at the best of times. While senior leaders are aware of the requirements & have drafted quality policies etc., practical ways of implementing these responsibilities seems challenging. This is especially true for small to mid-sized organisations & startups who are already juggling resources, project deliverable & workforce challenges.

So, how can management responsibilities be executed in a way that achieves not just compliance but also operational excellence? Here are my thoughts & experiences.

A senior management team, in my opinion, should always keep the following questions in mind:

1. What are our current business processes? How are we monitoring their performance?
2. Are our quality objectives aligned to our current business? Do we all have the same clarity around our policy & goals?
3. Where do want our organisation to be in the next 5yrs? Do we know the potential challenges, risks & benefits?
4. What is our quality monitoring data (metrics, audits, customer complaints, feedback etc.) telling us?

Below I have listed a few tools that can help answer some of the above questions.

Speaking the same language

Quality policy & objectives need to be clearly understood by every member of the management team. In addition, each member must be able to explain what the policy & objectives look like in practice. This explanation must be consistent across all functions. By focussing on the consistency of the message, intent & practical application, leaders convey their shared commitment towards quality for the entire business, not just for maintaining the GMP licence.

In my experience, I have discovered that the role of the senior management is to explain "why" and "what" is required to be done as clearly & consistently as possible. The "how" of that implementation must be left to the employees so they can come up with the most user-friendly/acceptable system.

Effective use of Management Review meetings

A fresh & holistic approach to conducting management review meetings is another way in which compliance & improvement can be achieved. Instead of conducting multiple management review meetings (e.g. one for Quality, another for operations, another for business processes etc.), a single meeting that includes an agenda encompassing all areas of the business is much more effective. Not only does this breakdown functional siloes but also helps to review a process holistically to assess performance, identify challenges, inter-relationships & brainstorm the best solution. It is a more effective use of time, resources & help the team prioritise improvement actions.

Meaningful & relevant KPIs

Are your KPIs aligned to your business goals, objectives & quality policy? How have the KPIs been identified? Do your quality metrics & other monitoring parameters align with the KPIs? Every member of the senior leadership team must have an answer to these questions. The continued relevance of KPIs & their subsequent monitoring should be reviewed during every management review meeting. Quality metrics should be selected based on the KPIs. The data collected from monitoring quality metrics & KPIs should help assess the effectiveness of implemented systems or identify areas of improvement.

Effective Communication

Seniors leaders must use a variety of communication methods to convey company's vision, goals & quality practices. Communication can be in the form of monthly newsletters, competitions, continuous improvement challenges & even Gemba walks. Having conversations with shop floor staff during Gemba walks, listening to their concerns/questions & addressing them on the spot can go a long way in enforcing a culture of trust, transparency & quality. Communicate both positive & negative examples so employees can understand the impact. e.g. if there has been a customer compliant, let the employees know what it was about, how it impacted the organisation (reputation, cost, time etc., what led to it & what corrective actions have been implemented. On the other hand, if a client has provided positive feedback, share that too with an emphasis on what that means for the organisation.

Fulfilling all management responsibilities successfully is challenging, especially the regulated environment that pharmaceutical/life science organisation operate in. However, implementing small changes & improvements can go a long way in getting started.

Food for thought

In the next management meeting, discuss the company's quality policy. Let every team member share their thoughts on the policy & what activities/practices in their organisation reflect compliance to the policy. Use this brainstorming session to identify the suitability of the policy, meaningful KPIs & quality metrics.

Let's hear your thoughts on management responsibilities. I would love to know what type of unique challenges you face, as a senior leader & how you have addressed these.

Live Events in Aug

I shall be part of three live virtual events this month. Do join!

Aug 13 2024 - Foundations for Digital Transformation - A guide to getting started

A virtual session on understanding the factors & elements that impact digital transformation & strategies that organisations can employ for successful deployment. I shall be the trainer.(AEST 12.30pm)

Aug 13 2024 - Emerging Models for Outsourcing Development and Manufacturing

A panel discussion focussed on understanding outsourcing strategies, new models for sponsor partnerships hosted by Outsourced Pharma . I am one of 4 panellists on this session. (EDT 2:00pm)

Aug 21 2024 - Supply Chain and Outsourcing Management

A 2-part symposium focussed on supply chain & outsourcing management within the pharmaceutical & life science industry, hosted by PDA Singapore Chapter . I shall be speaking on how to overcome outsourcing challenges & forging strong manufacturing partnerships, using quality systems. (SGT 1:30pm-4.30pm)

If you are interested in implementing a QMS program that supports both compliance & operational efficiency, or want to discuss a specific compliance/improvement project, pls visit my website Urmi Quality Management Consulting Pty Ltd to know more and book a call.