Who should participate: This one-hour course is directed toward laboratory directors, managers, analysts, quality control officers, and operators who oversee or perform laboratory and field measurements, and particularly those who must use and follow guidance from controlled documents, such as forms, standard operating procedures, logs, etc.

Learning objectives: Attendees will learn how to design, implement, and use a document control system that is appropriate for their facility. You will learn the essential requirements of a document control system, a required element of a quality system. After the course, you will know how to issue documents, how to make revisions, what elements need to be in documents, and how to keep these documents current.

Course Description: The course will cover the types of documents that need control, the objectives of a control system, and ways to perform the function efficiently. The role and benefit of document logs and numbering formats will be discussed. Contents of documents and their role will be discussed. Topics will include how to arrange documents in order to maintain a simple and understandable system.

Course Content:

Document Control SOP
      • Define the format for all SOPs and Forms
      • Define the procedure for approval of SOPs and forms
      • Define the distribution of SOPs and Forms
      • Define process to control SOPs and Forms
      • Define procedure to number SOPs
      • Define procedure to number Forms
      • Define procedure to number revisions
      • Define process to initiate new revisions
      • Define record retention procedures

Identify documents to be controlled
      • QA Manual
      • SOP's
      • Analytical Data Sheets and Run Logs
      • Calibration Curves
      • MDL studies
      • Batch records

Identify forms to be controlled
      • Reagent standardization
      • Thermometer calibrations
      • Balance Calibrations
      • Corrective Action
      • Customer Complaint

Establish System
      • Current revision of each document available for use
      • Computerized document control systems
      • Manual document control system

Revisions
      • Issued by responsible person
      • Process to identify obsolete revisions
      • Communication to affected personnel

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