TABLE 13.

Roles and responsibilities associated with document control

Activity(ies)	Role(s) and/or responsibility(ies)
	Institution	Microbiology laboratory management	Microbiology staff
Document creation	May provide a template for official documents	Establish a document control system that meets any institutional requirements	Inform supervisor if a new or revised document is needed
		Prepare new or revised documents with the appropriate control and revision no.
		Ensure that appropriate documents capture required information, data, and results to meet regulatory requirements
		Approve and review documents as required
Document access and storage	Provide a system for adequate and accessible storage of electronic and hard-copy documents	Provide a secure system for accessing documents	Use current versions of processes and procedures
		Determine if access to documents is appropriate for work
		Instruct personnel on document location and editing rules
		Determine the life span of a document according to regulations and standards
		Archive obsolete documents
Record creation	None	Review records for completion and follow-up of outlying entries	Enter information on forms according to good laboratory practices
		Sign and date records in a timely manner
Record access and retention	Provide a system for adequate storage of electronic and hard-copy records	Create a system for maintaining records for easy retrieval Ensure secure access to records Determine if access to records is appropriate for the work to be performed	Follow policy for restricting access to and sharing records Maintain all records of work
	Set institutional policy for record retention that complies with regulatory requirements
		Store, archive, or discard records according to record retention policies