MICLAB-125 Control of Microbiology Test Methods

5.1 Microbiological Test Method Template

5.1.1 Location

The template should be a Read Only file stored in the shared area of the network computers.  Changes to the template are made and saved by the Lab Manager or delegates.

5.1.2 Set Security attributes on template

5.1.2.1 Set Security attributes under “Tools” to “Password required to modify” checking the “Read Only” box.  Lab Manager should assign appropriate Password.

5.1.3 General Template Layout

5.1.3.1 Scope and Application: Details the test range the method covers.

5.1.3.2 Reagents and Materials Required: List the major or unique materials needed to carry out the test. This does not need to include standard microbiological items such as pipettes or loops unless specific details are required that cannot be detailed in the General Test Method section.

5.1.3.3 General Test Method: This details the actual test procedure from start to finish including any confirmatory testing that may take place.

5.1.3.4 Referenced Documents: List any documents directly referenced in the procedure.

5.1.3.5 Summary of Changes: Details changes of the current version from the preceded version.

5.1.4 Assigning a Document Number

5.1.4.1 Prepare a “Microbiological Test Methods Document Register”. Check the register to see if a Document number has already previously been assigned.  The register is stored in a designated place within the Microbiology Laboratory.

5.1.4.2 If a number doesn’t already exist, issue a new number and log the number into the “Microbiological Test Methods Document Register”.

5.1.4.3 This document number will be entered into the header of the draft document.

5.1.5 Withdrawal of Existing Documents

Find the original document code allocation in the “Microbiological Test Methods Document Register”.  Using a red pen, write a comment in the “Comments” column with regards to the document now obsolete.

5.1.6 Amendment to Existing Documents

For amendment to existing documents, the Version Number will be the next whole number from the current effective document; e.g. “2.0”, “3.0”, “4.0”, etc.

5.2 Providing the Word Document

5.2.1 Create Word Document.

For New Documents, create a new document by opening the MTM template.

For Amendment to Existing Documents, navigate to the effective folder. Copy the relevant Effective Word document and paste that copy into the Draft folder.  From Windows Explorer, remove the “Password Required to Open” and “Read Only” attribute from the properties of the Word document.

For Withdrawal of Existing Documents, providing a Word document is not applicable.  Notify the Lab Manager to obsolete the document.  Comment will be made in the MTM register.

5.2.2 Name the Word Document

5.2.2.1 For New Documents, save the Word document utilizing file name format: “MTM#### v#”; i.e “MTM0005 v1”.

5.2.2.2 For Amendment to Existing Documents, rename the Word document using the new version number.

5.2.3 Complete Word Document Properties

For New Documents, select the File => Properties menu option and complete the Properties as follows:

Title:              Title of the proposed new document

Subject:         Document type

Author:           Author’s name of the proposed new document.

Company:      Company name; i.e. “GMP”.

Click OK.

For Amendment to Existing Documents, select the File => Properties menu option and ensure the Properties are completed as follows:

Title:              Correct title of the proposed new version of the document

Subject:        Correct document type

Author:          Correct Author’s name of the proposed new version of the document. Company: Correct company name; i.e. “GMP”.

Click OK.

5.2.4 Complete Word Document Header

Select the View => Header and Footer menu option and complete or update all fields in the Header.

Save and Close the Word document.

5.3 Processing of Draft Documents

5.3.1 Set Security attributes on draft document

5.3.1.1 Set Security attributes under “Tools” to “Password required to open” and “Password required to modify” checking the “Read Only” box.  Lab Manager assigns appropriate Password.

5.3.2 Route Master Document

5.3.2.1 Print saved draft and route for signatures.

5.3.2.2 Once routed and approved provide document to Microbiology Lab Manager.

5.4 Processing of Approved Documents

5.4.1 Move Word Documents

5.4.1.1 For New Documents: Move the Word document from the Draft folder to the Effective folder.

5.4.1.2 For Amendment to Existing Documents: In addition to section 5.4.1.1, moves the previous Word document version from the Effective folder to the superseded folder.

5.4.2 Check Approved Master Document

Check Approved Master Document and ensure that:

ü       all signatures are present;

ü       the page numbering is correct

If any errors found, return Approved Master Document to the initiator for correction.

5.4.3 Create PDF Document

5.4.3.1 Scan signed document into PDF format.

5.4.3.2 Save PDF utilizing the following format: “MTM#### v#”; i.e. “MTM0005 v1” into the distributed folder.

5.4.3.3 Set security access by under the Secure option selecting “Require a password to open the document”. Lab Manager assigns appropriate Password.

5.4.3.4 Set properties of the PDF.

5.4.3.4.1 Into the Title field, type the document title.

5.4.3.4.2 Into the Author field, type the author’s name.

5.4.3.5 For Amendment to Existing Documents: In addition to sections 5.4.3.1 –  5.4.3.4 moves the previous PDF document version from the Distributed folder to the Superseded folder. NOTE: Only the current active version should be in the Distributed folder.

5.5 Distribution and Withdrawal

5.5.1 Distribution of new version

5.5.1.1 Print PDF version of document from the Distribution folder.  Password is required to open the document for printing.

5.5.1.2 Signs and dates bottom of first page as having distributed copy to Laboratory: Only Lab Manager or delegates can distribute documents.

5.5.1.3 Places new version into a protective sleeve within the MTM procedure folder  maintained within the lab.

5.5.1.4 Verifies current version is indicated as such in the MTM register.

5.5.2 Withdrawal of previous version

5.5.2.1 Removes previous version from the MTM procedure folder.

5.5.2.2 Using a red pen places a line across the first page and writes the comment  “Superseded”, initials and dates comment.

5.5.2.3 Verifies register indicates that version is listed as superseded per section 5.1.5.

5.5.2.4 Places superseded version into the Superseded MTM folder within the Microbiology Laboratory File Cabinet.