SfSAP and the Community
The Society for Sterility Assurance Professionals (SfSAP) aims to provide information that can be used by individuals and industry to develop the competencies of those involved in all leading sterilisation modalities with the goal of ensuring the sterility of medical devices, pharmaceutical and drug-device combination products.
An industrywide collaborative approach is being used that involves leading experts with practical experience in widely differing parts of the healthcare manufacturing community.
Do you want to see what we have been working on?
Download a sample of the learning frameworks (curriculum) and learning outcomes (required knowledge and skills) that are being developed by the subject matter experts by clicking on the links. In order to simplify the viewing experience the frameworks and learning outcomes have been consolidated into a single document for each of radiation processing, microbiology and aseptic processing.
Three Key Steps to
Competency
The need for a common interpretation of competency was initially driven by the need to meet medical device regulations (MDR) and evolving industry standards.
In order to establish a harmonised interpretation of the regulations and standards the learning ‘frameworks’ and ‘outcome’ that are being developed will provide sterility assurance professionals with a pathway for career development, manufacturing organisations with a mechanism to ensure staff competency, training organisations with information that can be used to develop learning programs, and auditors with the knowledge and skills necessary to support their work.
The collaborating experts have determined that it is necessary to acquire knowledge, demonstrate understanding and gain expertise appropriate to an individuals role in the sterility assurance lifecycle in order to establish competency. The learning ‘frameworks’ and learning ‘outcomes’ provide an objective basis for against which an individuals competency can be assessed according to need and according to their role in the sterilisation lifecycle .
The frameworks and outcomes will be refined with input from experts and from the community. The SfSAP aims to provide an agreed framework that will allow individuals and organisations to identify the the knowledge, skill and experience needed at different stages of a person’s professional development.
Knowledge
The knowledge that is required in order to perform a functional role within an organisation. Knowledge requirements will vary according the scope of the role.
Understanding
Proving that knowledge, in addition to being known, is understood. It is a key component in proving competency.
Expertise
Is achieved by applying knowledge + understanding in real world situations over an extended period of time.How will the Competency
Framework help me?
How will the Competency Framework help me?
- Assists individuals to plan and advance their careers.
- Supports employers who must meet regulatory requirements and wish to provide career development pathways for staff.
- Provides regulators with the detailed programs required to support audits and to demonstrate regulatory compliance.