VV_6.0_6.1 Resource Management

6.1   Provision of Resources

Supply Direct’s management is responsible for identifying and procuring the resources needed to fulfill the requirements of Supply Direct’s Quality Management System, provide for its continual improvement and effectiveness, and the enhancement of Customer Satisfaction.
 

6.2 Human Resources

General

Supply Direct’s management at all levels is responsible for ensuring personnel under their supervision performing work affecting conformity to product requirements are competent on the basis of education, training, skills, and experience.
 

Competence, Training and Awareness

• Managers and Human Resources determine the required competence for each position. Competence is defined as having the appropriate education, training, skills, and experience for a position. Education, skills and experience for each position is documented in the corresponding Job Description. Training  requirements  are defined for each position in departmental training procedures.
• Supply Direct identifies training requirements during initial hiring and employee performance reviews using education, training, skills, and experience listed in the Job Description and departmental training procedures.
• Training is evaluated for effectiveness through departmental training procedures, employee performance reviews and Corrective/Preventive Action follow-up.
• Supply Direct maintains Training Records on each employee. These records will contain objective evidence of an individual’s education and training.
• Supply Direct employees are made aware of the relevance and importance of their work performance and how this supports Supply Directs’ Quality Objectives. Employee bonuses are tied to Quality Metrics.

The HR department and/or company management has determined the necessary competence for personnel performing activities affecting product quality and provides training for them. Throughout this training, personnel are made aware of the importance of their activities and how they contribute to the achievement of the quality objectives.
 
Training records for each responsible are maintained as described in the SOP for Personnel and training.

Applicable Procedures/Instructions:
Procedure-Education and Training

6.3 Infrastructure

Supply Direct management determines, provides, and maintains the infrastructure needed to meet product requirements. Infrastructure needs are evaluated and planned during process improvements. Infrastructure needs are also identified in Corrective and Preventive Actions.

Applicable Procedures/Instructions:
Procedure-Document Control
Procedure-Quality Audits

6.4 Work Environment and Contamination Control

6.4.1 Environment

Supply Direct management determines, provides, and  maintains  the  work  environment needed to meet product requirements  and employee  safety.  Managers  are responsible  for the work environment within their managed work area.

•  Safety,
•  Heat and Humidity,
•  Cleanliness
•  Sterility of disposable devices
•  Clean room manufacturing

6.4.1 Contamination Control

Not Applicable. Organization does not work with sterile materials.