Quality management systems (QMS) are widely adopted in business and the public sector to help ensure timely, accurate and consistent implementation of day-to-day functions. The QMS are specific to each function in an organisation and are comprised of the following components that keep them current and useful where they are deployed:
One of the biggest benefits of QMS for the public sector is the institutional memory that the systems establish. The public sector is plagued in many countries by a highly mobile workforce, which leaves critical positions unmanned from time to time. Establishing a QMS for biosafety administration will enable a biosafety framework to keep functioning with minimal disruptions when key personnel move to new positions.
The guidance for QMS generally comes in the form of manuals, such as this one, and includes standard operating procedures (SOPs) that detail the work processes that are to be conducted or followed within the organisation. The SOPs document the way activities are to be performed and should be made available to all personnel to facilitate consistent performance and institutional memory to cope with the movement of staff. This documentation helps to maintain quality control and can provide quality assurance processes for all of the important actions in the national biosafety office.
While general guidance documents are available, it is important that they are adapted to be specific to the organisation or facility where the functions are performed. Importantly the guidance should reflect the national biosafety policy and the authorisation under which the activities are being implemented. This helps to ensure compliance with governmental regulations and policies.
Documentation of specific actions is important for maintaining adequate records of all activities in the national biosafety office. This documentation is most often formatted as a set of forms that are completed as activities progress. These forms can be used to demonstrate that the national biosafety process is being managed in compliance with the regulations and the documentation can be examined by regulatory personnel and auditors to help investigate and understand problems should these arise. Importantly, to ensure that the documentation system remains viable and is implemented readily by biosafety personnel, it should be reviewed annually to see where improvements can be made.
In most countries regulatory documentation is handled electronically. Thus the basic electronic backup and disaster recovery systems are important, as is the security to ensure that the files and records are only accessed by authorised personnel.
All personnel involved with biosafety administration should be properly trained to ensure that they understand their responsibilities and are able to:
- Handle applications and administrative activities properly
- Keep records that are accurate and correct, and
- Take appropriate actions in the event of problems arising
The training should review all the QMS that will be used by personnel and they should have access to copies of all the relevant guidance documents and standard operating procedures. However, this documentation should not be considered a replacement for face-to-face training of personnel and all training should be recorded to ensure that staff members are updated regularly on the latest processes. It can be useful to combine training with the review of current systems, so that problems can be identified and addressed and improvements can be implemented.
4. QMS inspection and audit
Inspection and audit systems are valuable where regulatory compliance is essential or where quality assurance levels affect the functioning and economics of a process. In the public sector, maintaining a high level of service and keeping within appropriate timelines may require regular inspection during the implementation stages of a biosafety administrative process and QMS development.
Auditing involves the appointment of an external expert to review the QMS in an organisation and to recommend where improvements are needed and where changes could facilitate the functionality of specific activities. Many governments have existing public sector auditing processes that could provide this review process for biosafety regulation.
5. QMS review
It is recommended that SOPs, forms and training curricula are reviewed annually to ensure that they are updated and functional. Outdated documentation and reporting systems for QMS can become obsolete and cumbersome. This leads to non-compliance with the measures and can result in a breakdown of the processes. Annual reviews are usually undertaken by the personnel who use the QMS and are coordinated by management to ensure that the recommendations for renewal are implemented in a timely manner.