Clinical risk management training

Where a variation to the process is considered, this should be formally documented in the CRM Plan for each system under assessment along with the rationale and jnstihcation for the variation. The process documentation itself could also set out any basis for omitting relevant steps. Building in process flexibility at the time of SMS development facilitates the straight-forward justification of the approach when one applies the process to a product. 

In practice, the file needn t be a physical paper folder or filing cabinet but more usually an electronic repository or document management tool. Maintaining this collateral in a single (virtual) place greatly facilitates audit and supports an organised approach. Also note that in many cases much of the content of the file will be material which is not specific to CRM but pertains to the project more generally. It is common practice to refer and reference out to this material rather than provide duplicated copies within the file itself (and risk the loss of version control). 

In large organisations it is common for a general-purpose document management system to be implemented - in most cases it makes sense for CRM materials to harness these tools. A document management systan will typically set out the strategy for  

Document registration and coding Version and configuration control Storage, retrieval and backup Editorial standards Common terms and definitions Document templates, branding and copyright notices Peer review and sign-off processes 

The need for CRM training, a proposed methodology for its delivery and collateral which supports it form an integral part of the SMS. Demonstrating that CRM processes are underpinned by effective communication and socialisation adds significant credibility to the approach and raises confidence in its rigour come an audit. Consideration should be given as to  

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Determine, for a particular project, what roles need to be fulfilled within the CRM team to provide an appropriate skill mix. For example this might include a clinical domain expert, risk management representative, technical expert, system administrator, training lead, etc. Each role should be accompanied by a brief job description and areas of responsibility. 

Ascertain the skills, experience and qualifications required to operate in that particular role. For example, the domain expert might need to have at least 5 years practical clinical experience and possess an affiliation with an appropriate professional body. The risk management representative should perhaps have received specific training and be able to evidence previously issued safety cases. Note that these criteria should be established in a vacuum and not be reverse engineered based on the characteristics of the individual whom one has in mind for the role. 

Margareta Haelterman is head of the Quality team at the Health Care Department of the Belgian Federal Public Service Health, Food Chain Safety and Environment, Brussels. Trained as a medical doctor and epidemiologist, she now coordinates a team promoting patient safety culture, quality systems, risk management, implementation of iimovative processes in care and the use of clinical indicators in different clinical domains. 

In anticipation of the introduction of risk management requirements under 1EC80001 (or in case of expansion of the scope of the Medical Devices Directive), the NHS Connecting for Health (CfH) Chnical Safety Group commenced creating and training a network of Trust based Clinical Safety Officers to assist in the safety management tasks associated with new systems deployment. 

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