Contract staff

Many of the technical requirements of the Standard are covered in Chapters 4 to 7. The analytical requirements, including choosing a method and method validation, are covered in Chapter 4. The other measurement requirements, such as calibration, traceability and equipment qualification, are dealt with in Chapter 5. Some of the general issues not covered elsewhere are mentioned in the following sections. It has already been mentioned that staff should be trained and proven to be competent to carry out the testing. This applies to permanent and contracted staff. The laboratory should have a job description for all members of staff. There are more stringent requirements on staff who are also able to provide customers with opinions or interpretation of the results. 

Pharmaceutical and healthcare companies still have substantial concerns over the most appropriate way to address the organization of validation and how to enable management to fulfill its responsibilities. This chapter suggests a typical approach that satishes a company s accountabilities. However, in presenting this offering we do not purport to suggest that this is the only acceptable approach. The needs of pharmaceutical and healthcare companies will vary since they depend on many different factors, including the scope of the validation requirement, the availability of suitably skilled corporate and contract staff, and cost. 

Another issue that has practical implications on validation is the use for third parties to maintain and support networks, hi these circumstances contracts must be established with the supphers defying what procedures will be used by contract staff and what records will be maintained and/or... 

Training records must be maintained for all staff involved in the implementation, operation or support of the infrastructure. This will include contract staff and third-party arrangements. 

The people involved in an enterprise software project extend far beyond the immediate project team. It will involve all levels of management and staff of the organization, including information technology staff, technology vendors, integration partners, and perhaps a host of consultants, subcontractors, or contract staff. 

Where contract staff are hired on a temporary basis and are put to tasks for which training is considered necessary for full time employees, the employer is required to give those temporary staff the same training. 

All the organization s employees, the organization s professional staff, contracted staff, house staff, students, volimteers, patients, parents, legal gnardians, and visitors have the responsibility and anthority to immediately intervene to protect the safety of a patient, to prevent a medical accident, or to avert a sentinel event. It is the expectation that all participants will immediately stop and respond to the request by reassessing the patient s safety. 

Combining proprietary and contract staffs can be an effective and efficient answer. Many security directors conclude that proprietary and contract services have complementary benefits. Therefore, they include both types of services in their operations strategy. 

Organisations should develop a programme for the promotion of process safety by active senior management engagement with the workforce, both direct and contract staff, to underline the importance of process safety leadership and to support the maintenance of a positive process safety culture within the organisation ... 

Other Special Circumstances. Facility A is undergoing major maintenance and construction, so a large number of temporary contract staff is on-site, working around the clock. 

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