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Volume II - Instrument and Equipment Documentation and Records ORA-LAB.5.5.1

 

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ORA Laboratory Procedure

Food and Drug Administration

DOCUMENT NO.:

ORA-LAB.5.5.1

VERSION NO.:1.3

Instrument and Equipment Documentation and Records ORA-LAB.5.5.1

EFFECTIVE DATE: 10/01/2003 REVISED: 05/02/14

Sections Included in this Document and Document History

  1. Purpose
  2. Scope
  3. Responsibilities
  4. Background/(Revised)
  5. References/()
  6. Procedure/(Revised 6. A. & B.)
  7. Definitions
  8. Records
  9. Supporting Documents
  10. Document History

 1. Purpose

This procedure provides guidance for the International Organization for Standardization (ISO) 17025 documentation requirements for laboratory testing equipment in the Food and Drug Administration /Office of Regulatory Affairs (FDA/ORA) laboratories.

 2. Scope

These procedures apply to equipment maintenance, performance checks, calibration, and verification documentation of the FDA/ORA laboratories.

 3. Responsibilities

ORA laboratories ensure that laboratory testing equipment is maintained, monitored, calibrated, and verified properly before use.

 4. Background

ISO/IEC17025 requires laboratory equipment documentation. FDA/ORA laboratories maintain records electronically, in logbooks, or other kinds of document files

Records include instrument related information such as descriptions of operation, preventive maintenance, repairs, calibrations and verifications. Volume II, Section 2, ORA-LAB.5.5 Equipment provides guidelines on instrument and equipment performance measures and maintenance. Periodic review of the instrument and equipment records, included as part of the laboratory’s audit procedure, is essential.
 

 5. References

International Organization for Standardization and International Electrotechnical Commission. International Standard (ISO/IEC) 17025 General requirements for the competence of testing and calibration laboratories (Section 5.5 Equipment).  Geneva, Switzerland: ISO Committee on Conformity Assessment.

 6. Procedure
 

  1. Overview
    1. The instrument or equipment records are compiled and required information maintained in a readily accessible manner. There is no requirement that the records be kept in a bound notebook or binder. Records may be kept electronically. For electronic records, local work instructions state where these records are located, how they can be accessed, and authorized personnel.
    2. The records are kept in a secure, accessible place in the laboratory.
    3. The records for similar instruments may be kept together if they are clearly identified and separated. For example, multiple balances may share a single location.
    4. The records are maintained for a period determined in each laboratory’s record and data management procedure.
  2. Logbook Sections
    1. The following information may be included in the:
      • description of the instrument, critical accessories and software;
      • manufacturer's name, type identification and serial number;
      • FDA number;
      • installation qualification (IQ) and operational qualification (OQ) records obtained from the installer or manufacturer; and
      • other related material such as instrument service and repair, warranty information, service contract conditions and specifications, and equipment manufacturer representatives names and telephone numbers.
         
    2. Operating Instructions

      Each instrument or piece of equipment has step-by-step operating instructions, including starting and shutting down the instrument. This may be addressed in manufacturer’s manuals or per laboratory procedure.
       
    3. Calibration and Verification
      1. Each instrument has an established schedule specifying performance checks, including the testing frequency and acceptable performance specifications. These performance checks ensure the instrument is operating properly and consistently prior to analysis.
      2. Instruments may have peripheral equipment that affect their performance. In these cases, systematic checks are also specified to ensure that the peripheral equipment is functioning properly. For example, tests of voltage regulators ensure voltage stability of automatic samplers for consistent sample delivery.
      3. The performance check includes a description of the performance check, the date and analyst name, the determined value compared to a target value or specification, and any information to aid in instrument assessment.
      4. Quality control procedures monitoring test validity and calibrations connected to a particular sample are generally recorded on the worksheet or electronically. For example, system suitability test results performed as part of sample analysis are submitted with the worksheet.
      5. For instrument performance checks where traceability to primary standards is needed, a certificate or documentation establishing traceability or information about the properties or characteristics of the reference material is kept on file.
      6. When contract calibration or verification services are used, the vendor should provide the following information (if not proprietary):
        • Description of work performed,
        • Test method,
        • Test data,
        • Traceability of standards used,
        • Date vendors test equipment or standards were last certified,
        • Performance versus the acceptance criteria, and
        • Certificate of conformance.
           
  3. Maintenance
    1. Service contract or in-house preventive maintenance is documented. This documentation is required for annual maintenance.  Maintenance performed at other times, with the exception of routine cleaning, is documented.
    2. The documentation includes:
      • description of the maintenance;
      • date it was done; and
      • name of the service representative and company, or name of the analyst if maintenance provided internally.
  4. Repair
    1. Instrument and equipment repairs are documented.
    2. The documentation includes:
      • initials of the analyst, and the date the problem was observed,
      • description of the problem;
      • date and initials of the analyst or service representative performing the repair;
      • synopsis of the repair; and
      • cost of repair, copy of the invoice and any additional information (not required).
         
  5. Non-Conformances
    1. If limits or specifications are exceeded, explanatory documentation is required. Documentation includes the limit of specification that was exceeded, and the probable cause and resolution.
       
    2. Non-conformances are handled by the laboratory's corrective action procedure, See Volume II, Section 1, ORA-LAB.4.10 Corrective Action Procedure.
       
  6. Software Record and Calibration

    Software calibration certificates provided by the manufacturer are kept on file by the laboratory.
     
  7. Manufacturer's Instructions

    Manuals provided by the equipment manufacturer may be included in the logbook if they are very brief, significant, and readily accessible.

 7. Definitions

None.

 8. Records

Laboratory equipment records for maintenance, performance checks, calibration and verification
 
Laboratory equipment service and repair records
 
Installation qualification (IQ) and operational qualification (OQ) records obtained from the manufacturer
 
Primary standard certificates 
 
Software calibration records

 9. Supporting Documents

ORA laboratory manual of quality policies and procedures, Volume II, Section 2, ORA-LAB.5.5 Equipment
Laboratory record and data management procedure
Laboratory corrective action procedure

 10. Document History

Version
No.
Status
(I, R, C)
Date
Approved
Location of Change History  Name & Title
Author Approving Official
 1.2  R  11/16/05  In Document  LMEB  LMEB
 1.3  R  05/08/14  In Document  LMEB  LMEB
           
           
           

 

 

 

 

 

 


Approving Official's signature: _________________________________ Date: _____________