Hi Rashmi

The GPG doesn’t state that a capacity plan is required but it is a way for the personnel resource requirements to be determined so that compliance to the following can be achieved.

1.2.2. The Quality System encompasses quality management, quality assurance, continuous quality improvement, personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution, quality control, blood component recall, and external and internal auditing, contract management, non-conformance and self-inspection.

1.2.5. Executive management has the ultimate responsibility to ensure that an effective Quality System is in place and resourced adequately, and that roles and responsibilities, are defined, communicated and implemented throughout the organisation. Executive management’s leadership and active participation in the Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Quality System.

2.1. Personnel must be available in sufficient numbers to carry out the activities related to the collection, testing, processing, storage and distribution of blood and blood components and be trained and assessed to be competent to perform their tasks.

2.2. The organisation should have an adequate number of personnel with the necessary qualifications and experience. Management has the ultimate responsibility to determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the Quality Management System and continually improve its suitability and effectiveness through participation in management review. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.

This underpins the fact that personnel are a central cog in the management of every Quality Management System and as such the management has the ultimate responsibility for providing this resource that is fit for task to ensure business continuity through an adequate BCP.

To ensure adequate resource, relevant evidence needs to be provided so sufficient capacity is available to suit all situations so business continuity can be preserved.

I hope this helps.

BW

Mike