LABORATORY PROCEDURES FOR MICROORGANISMS
REFERENCE NO.: M/1998/1.07
TITLE: ISSUE, CONTROL AND UPDATING OF LABORATORY PROCEDURES
All procedures carried out in any laboratory should have a formal protocol available for reference purposes. The methods described in the laboratory procedure documents should be strictly adhered to. Risk assessments should be referenced according to national and European regulations.
Issue and Control of Laboratory Procedures
1 All methods should be written down clearly and concisely giving easy to follow stepwise instructions. The procedures should be written in the language of the collection staff. Instructions for procedures used by non-native persons should be available also in English language.
2 Procedures should then be passed to the person responsible for the control of laboratory procedures (PRCLP) in the collection. The PRCLP may make proposals to change, to amend or to reject a procedure.
3 After the procedure has been accepted the PRCLP will assign a unique identification number to the procedure (e.g. M/1998/3.02). This number may reflect the section (M/ for Microorganisms), the year of preparation (YYYY/) and the part of the guidelines (1. to 4.) and a procedure number (00 to 99). Alternatively, a numbering system imposed by the quality manual of the collection's host institute may be used.
4 After drafting a procedure it should be passed to the head of the collection or to a person designated by the head for signature.
5 A list of recipients of signed procedures and document locations is retained by the PRCLP.
6 All procedures concerning a laboratory should be placed in clearly identified files which also contain an inventory of all procedures. The files should be available in that laboratory.
7 All procedures of the collection and an inventory of all procedures is to be found in the collection office and is stored in a computer file.
8 Proposals to amend a procedure should be forwarded to the PRCLP and must be authorised by the head of the collection or by a person designated by the head.
Guidelines prepared for CABRI by DSMZ, CBS and BCCM, 17 May 1998
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