HOW TO WRITE A PROCEDURE Instruction: The following describes the means of formatting and documenting Procedures using the

generally accepted method and headings. Purpose: The Purpose is a required paragraph to outline the objective or intention of the document. For example, if a procedure is being written to control documentation and data, the phrase outlining the purpose of the procedure could be written as follows: The purpose of this procedure is to provide instruction on and assign responsibility for systematically controlling, the issue, receipt, revision and withdrawal of all documents and data. Scope: The scope is a required paragraph to outline the applicability and breath of the procedure including the area, department, group or personnel to which the procedure applies. Using the document and data control procedure again as an example, the scope could be phrased as: This procedure applies to all tasks related to the position of . In the ( ) department. Responsibility: The Responsibility recommended paragraph identify who is responsible for what. The responsibility may be identified as the organizational unit or the individual function responsible to implement the document to achieve the purpose.

For document and data control the responsibilitites of who identifies, review and authorizes procedures: who prepares and writes procedures and who administers and controls documents and data should be described. Procedures should be written: - by personnel familiar with the activities to be described and functions to be controlled - in the companys accepted format. Procedures need not be written in formal language but should be clearly understandable by the affected employees. To write a procedure consider: Using a flow chart to assist in establishing the current practice, then document the existing methods for revision and agreement, It is important to understand how each activity is carried out., how each step is initiated, and how it leads to the next step. To establish the current practice: - review the existing activity to determine how it is currently performed - determine what procedural information already exists for the activity - record routine methods of performing the activity - identify responsibilities - determine current standards, if any, and how effectively they are being achieved

- identify those aspects that impact on quality and how efficiently this is achieved Review the current practice with the appropriate and responsible personnel to determine: -if the specified objectives are being achieved -the best methods to achieve the agreed quality -if the current quality levels are adequate gaps, duplications, and weakness including departmental interfacing -opportunities for improvement Review the GMP needs for the job Review the Health and Safety needs for the job Ensure that the procedure is encompassing of all the needs The next step is to write the procedure and remember: -An effective procedure provides the necessary control to achieve the desired result. -use the flow-chart as a reference. -Include only instruction specific to the activity defined in the purpose and the scope of the procedure -Use references to other procedures to address related activities -Detail the procedure depending upon the personnel for whom it is written. -Involve those effected by the procedure implementation during the draft stage. Assigns of ownership assists implementation. -Review the draft procedure with the appropriate people to assure it is workable. Consider comments received for pertinent modification or additions.