In our continuing analysis of the current DCB 0129/0160 standards in anticipation of the forthcoming review, we’ve got another couple of points to raise for discussion. In this case, we’re going to focus on governance.

The current DCB 0129 and 0160 standards note a couple of requirements with regards what is referred to as ‘Top Management’. This is an important concept in risk management as it ties in an organisation’s key decision-makers into the process. Virtually all safety-critical industries have found that the engagement of senior leaders is absolutely critical to the success of a safety management system. Many would argue that it is the single most important aspect of the whole process.

With regards Top Management, the requirements talk about the provision of sufficient resourcing, the competency of personnel involved and the need for authorisation, but given the fundamental importance of Top Management engagement, this feels surprisingly light. I would suggest that a couple of requirements are introduced here for additional rigour.

Firstly, an obvious omission appears to be the absence of any need for Top Management (or indeed anyone else) to govern implementation of the safety process. It tends to be a facet of human nature that unless processes are formally and pro-actively governed, well, we all tend to get a little lax and shortcuts gradually creep in. The standards do mention that the Clinical Safety Officer is responsible for making sure the process is followed but that’s a poor substitute for formal governance arrangements. And of course, that governance is only useful if there is evidence of it actually taking place.

We therefore suggest that a requirement such as that below is included in the standards to improve rigour in this area:

“Top Management must ensure the effective implementation of the clinical risk management process and oversee its continuous monitoring to maintain effectiveness. Clear and auditable evidence of governance activities related to clinical risk management must be documented and retained."

Secondly, if we scan across the many Trusts whom we work with at Safehand, we can see a very real pattern emerge. Those Trusts who have a named representative of Top Management who actively engages in the safety activities, appear to have a much greater success rate than those where Top Management takes the form of a committee. There’s something about personal accountability which makes safety governance far more effective, visible and real. At Safehand, we encourage all of our customers to nominate a named ‘Safety Sponsor’ who acts as the key representative of Top Management. We also find it helpful for this individual to be an additional signatory to the safety documentation.

We therefore propose that the following requirement is added to the DCB 0129/0160 standards

“The manufacturer/healthcare organisation must designate a Safety Sponsor. The Safety Sponsor shall act as the key representative of Top Management and be actively engaged in overseeing the clinical risk management process.

The Safety Sponsor must:

  • Be a member of Top Management.
  • Have direct responsibility for overseeing safety governance and performance.
  • Actively engage with safety teams and contribute to the development and implementation of the clinical risk management process.
  • Be an additional signatory to all safety documentation, confirming their commitment to the safety process and demonstrating accountability.”

So that’s our thoughts on leadership and governance. Do you agree?