Capability Maturity Model for Quality Management

TRI develop a capability maturity model for Quality Management and Risk-based Monitoring.

What is a Capability Maturity Model?

A capability maturity model (CMM) is a simple way to express an organisation’s capability in a defined area against a number of parameters. The traditional model offers five levels of maturity, typically defined as 1 – Initial, 2 – Managed, 3 – Defined, 4 – Managed, 5 – Optimized, as seen in the diagram below:

cmm1

At each level on the model, the organisation exhibits greater capability, and hence gets more value from that capability.

How is a CMM used?

Typically the way in which companies use a CMM is to assess three things:

1 – where am I now on the CMM?

2 – Where do I want to be on the CMM?

3 – where are the rest of industry / my peer group / my competitors on the CMM?

When we work with there models with our customers, we typically use the gap between 1 and 2 as the starting point for the development of a road map to guide that customer to their desired capability level. Industry or competitor benchmark can also be a useful in gauging where an organisation should be, even if that is not as high up the model as they would like to be.

How is this relevant to Quality Management, RBM and the incoming ICH Rev2  guidelines?

Over the last three years there has been a lot of interest, discussion, guidance and background noise about quality management and risk-based monitoring. Industry bodies such as Transcelerate and the Metrics Champion Consortium (MCC) have developed their own guidance and tools, but there is still a lack of clarity as to what is really important, what is needed in order to be GCP compliant and what to do if you are not a major league Pharma or CRO.

The ICH have responded this year with issuing their draft guidance, which has added a completely new section (section 5) on quality management:

ICH GCP Rev 2 Guidance

So with all this new information, we are still hearing many of our customers and industry contacts asking us the same question:

“What do I need to do in order to be compliant, what tools to I need, if any, and what is the value in moving beyond basic compliance and further up the maturity model?”

At TRI our aim is to make quality management and RBM as simple, pragmatic and valuable as possible. So we decided what would really help our customers and industry in general would be to take the CMM concept and develop a model specifically designed for this purpose. We decided that promoting anything other than GCP Rev 2 compliance as a minimum would not be appropriate, and so created a new level1 – “Compliant” as opposed to the usual “Initial” level. This sets a basic minimal standard for what is required in terms of compliance. The model is broken into four components:

  • Organizational characteristics – what are the characteristics shown by an organization who has reached this level of the model?
  • Processes – what level of process definition does a company need in order to be at this level?
  • Technology – what level of technology does a company need in order to be at this level?
  • Operational Capability – what level of capability do the people within the organisation need to have in order to be at this level?

What benefit will I get by using the model?

First and foremost, you will get a simple and clear definition of what is required in order to be compliant with ICH GCP E6 Rev 2, in terms of processes, technology and operational capability.

Secondly, you will have the opportunity to understand the value of moving beyond that initial level of basic compliance and what the route to achieving that might look like.

Finally, TRI through our experience of working with more than 30 companies in the field of quality management and RBM will guide you to the most efficient and cost effective way of achieving your goals.

Will it cost me anyhting?

So here’s the really good news – absolutely nothing! TRI are committed to supporting companies of all types and sizes in understanding and getting value from quality management and RBM. We get a lot out of the process in terms of understanding where each company is at, what their main challenges are and how best we can serve them. The best way for us to achieve that is by talking with as many people as possible. If you work for a Pharma company or CRO and are actively involved in trial management or quality management then we’d love to hear from you.

What do I do next?

Simply complete the form below:

“I would like a copy of the CMM and to understand what compliance to the
new quality management section 5 of ICH GCP Rev 2 means for me.”