Personnel Practices

Pipetting must always be performed using mechanical systems. Oral pipetting of known or suspected chemical carcinogens, their solutions, or of toxic compounds, should not, under any circumstances be allowed. 

During all operations in which chemical carcinogens are involved, all personnel should wear protective clothing (see Section 2.5 (3)), which they must remove 

Eye protection devices, appropriate to the type of work performed, should be used in the laboratory work area. 

With regard to the employment of pregnant women in laboratories where chemical carcinogens are handled, medical and legal advice should be sought, and each institution should adopt an appropriate policy. 

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Vulnerability Any weakness that can be exploited by an adversary to gain access to an asset. Vulnerabilities can include, but are not limited to, building characteristics equipment properties personnel behavior locations of people, equipment, and buildings or operational and personnel practices. 

Review personnel practices, gowning, sanitation, and sterilization. 

This test is not regular practice but shall be used if a resistant microorganism is detected, for cleaning techniques and personnel practices trouble-shooting, or for a specific disinfectant. 

If sterility test contaminant is same as routine environmental contaminant the sterility test is voided. Investigate sterility test procedures and room sanitation/sterilization methods to eliminate cause. If media-fill environmental contaminant is same as routine environmental contaminant increase the number of media-fill vials in media hll to determine the product risk potential. Review monitoring technique for possible problem. Review personnel practices, gowning, sanitation, and sterilization. 

The process of evaluating the firm s overall operation, such as the laboratories, manufacturing sites, packaging and storage areas, quality systems, and personnel practices is usually a long one and may require an FDA team approach, as discussed above. Having invested in a third-party internal audit that mimics the FDA PAI process is extremely prudent and a smart investment of resources. 

Proactive mindset—Auditing should not be its primary function. Periodic evaluations focused on compliance and quality trends and assessments of personnel practices and adherence to SOPs would serve to alert CQA of potential issues before serious problems arise. Sharing a vision of quality early on is key. 

IEST-RP-CC027.1 Personnel Practices and Procedures in Cleanrooms and Controlled Environments, Apr. 1,1999. 

When the match of the system design and operations methods and personnel practices (selection, training, et cetera.) is less than adequate, causal factors attributable to the mismatch will arise. 

Here I was in the hospital with a medical doctor apologizing to me for the fact that the organization had injnred Jim so badly that he could not return to work the next shift. Some organizations, safety departments, and safety personnel practically intimidate doctors into releasing patients injnred on the job back to work, in order to preserve the safety record. 

Inadequate personnel practices regarding Employee selection Communications Training... 

In the spring of 1944 an audit team from the Office of the Secretary of War visited Huntsville and found defects in the methods of wage administration employed at the arsenal. This discovery led to a survey by the Personnel Division, OC CWS, which resulted in a number of suggestions not only on wage administration but also on the centralization of civilian personnel functions, the substitution of civilians for military as personnel officers, and the training of operating officials in sound personnel practices. From July to December 1944 those measures were largely carried out at Huntsville and resulted in a marked improvement in personnel administration. ... 

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