General requirements for testing laboratories

1 Introduction

The Australian Quarantine and Inspection Service (AQIS) ensure that all aspects of inspection in Australia are delivered to a prescribed standard. This includes ensuring that appropriately validated procedures are used for monitoring performance of the system, particularly with regard to microbiological testing.

AS ISO/IEC 17025-2005 “General requirements for the competency of testing and calibration laboratories” details requirements for laboratories carrying out testing. Currently, laboratories undertaking ESAM (E. coli and Salmonella) testing are required to be NATA accreditated and hence adopt the requirements detailed in AS ISO/IEC 17025-2005. While all laboratories carrying out microbiological testing are encouraged to adopt this standard AQIS recognises that for certain laboratories, such as on-plant laboratories undertaking limited testing, such as rapid tests for E. coli O157:H7, that the requirements of the standard may be onerous or difficult to apply.

The following document details the minimum requirements for on-plant laboratories undertaking testing carried out as part of AQIS certification and applies only to laboratories that are not NATA accreditated. General requirements for approved laboratories and accreditation bodies can be found in “AQIS Approved Laboratory Program (Meat and meat products)”, available on the AQIS web site.

2 General Information

2.1 Scope

This document applies to laboratories undertaking microbiological testing as part of AQIS certification, testing relating to sanitation SOPs and in some cases testing for pathogens that is part of customer requirements. All other testing that is part of a company’s approved arrangement (AA) and that impacts on the final quality or safety of the product produced must be carried out in a laboratory that meets the requirements of this document.

3 Management Requirements

3.1 Organisation

3.1.1 The responsibilities of key personnel in the organisation that have an involvement or influence on the testing activities of the laboratory must be defined in the company’s AA.

3.1.2 The laboratory must have documented arrangements that ensure that laboratory personnel are free from undue internal and external commercial, financial and other pressures or influences that may adversely affect the quality of their work. The laboratory manager must have direct access to the highest level of management and should not be answerable directly to the production manager.

3.1.3 The laboratory must provide adequate supervision of all staff.

3.2 Management system

3.2.1 The laboratory shall establish, implement and maintain a (laboratory) quality manual that details policies, systems and procedures necessary to ensure the quality of the test result.

3.2.2 The quality manual shall contain detailed work instructions for all methods used by the laboratory including quality control procedures.

3.2.3 The laboratory shall establish and maintain procedure for the control of all documentation relating to the management system, including procedures for approval and document changes.

3.2.4 The laboratory shall have a policy and procedure for selection and purchasing of supplies that ensures that the quality of the test results is maintained.

3.2.5 The laboratory manager shall participate in plant management meetings and actively seek feedback on performance.

3.2.6 The laboratory shall have a written policy and procedure that must be implemented when any aspect of the testing does not conform to the procedures.

3.2.7 The laboratory must record non-conformities and corrective actions taken. This must include an assessment of the significance of the non-conformity on the analytical results.

3.2.8 Internal audits of the laboratory management system shall be undertaken annually.

3.3 Control of records

3.3.1 The laboratory shall establish and maintain procedures for the identification, safe storage and disposal of records.

3.3.2 The laboratory shall retain records of original observations and other records required to establish an audit trail. This must include calibration records and test reports.

3.3.3 Where mistakes in recording are made such mistakes must be crossed out, not erased, and initialled by the person making the correction.

3.3.4 Calculations and data transfer must be subject to appropriate checks.

4 Technical Requirements

4.1 Personnel

4.1.1 Laboratory management shall ensure the competency of all staff based on appropriate education, training, experience and/or demonstrated skills as appropriate.

4.1.2 The laboratory shall maintain current job description for all staff involved in testing.

4.1.3 Laboratories shall maintain records of relevant staff competencies including training.

4.2 Accommodation and environment

4.2.1 Laboratory management shall ensure that the environmental conditions in the laboratory do not compromise the validity of the test results and monitor conditions as required.

4.2.2 The laboratory must be effectively separated from the rest of the plant and the work flow is designed to minimise cross-contamination.

4.2.3 Access to the laboratory must be restricted to authorised personnel.

4.2.4 Laboratories shall be well lit, air-conditioned and free from draughts (ie no opened windows).

4.2.5 The laboratory must be kept clean and free from dust.

4.2.6 A dedicated hand wash station must be provided.

4.3 Test Methods

4.3.1 The laboratory must use appropriate methods for the analysis being performed. Where applicable AQIS approved methods must be used.

4.3.2 Non-standard methods or in-house methods must be validated by the laboratory before being used for the analysis of test samples. Note, AQIS approved methods must be used for testing that is part of AQIS certification.

4.3.3 Validation data must be made available to regulatory authorities, including AQIS, upon request.

4.3.4 Methods must be documented in sufficient detail to provide clear, stepwise instructions to staff and should contain the following information:

• Unique identification;
  
• Scope (including reference to standard methods if appropriate);
  
• Type of sample to be tested (ie carcase swab);
  
• Dates of sample receival, when analysis was conducted, and test report issue date;
  
• Apparatus and equipment required including performance requirements (ie water bath running at 37 ± 1ºC);
  
• Reference standard and quality control required;
  
• Environmental conditions required and any stabilisation required (ie tempering of molten agar prior to use);
  
• Description of procedure including labelling of samples, check of equipment to be performed, recording of observations, calculation of results (including a worked example) and reporting; and
  
• Acceptance and rejection criteria for relevant aspects of the analysis ie sample receipt.

4.4 Equipment

4.4.1 The laboratory must be furnished with all equipment necessary to ensure the validity of the test results.

4.4.2 Equipment must be capable of achieving the accuracy required by the relevant test being carried out.

4.4.3 All equipment must be uniquely identified.

4.4.4 All equipment must be appropriately calibrated and any correction factors relating to calibration must be applied.

4.4.5 pH Meter

4.4.5.1 pH meters must be accurate to 0.1 units.

4.4.5.2 Calibration of pH meters must be undertaken daily when in use using two buffers, generally pH 4 and pH 7.

4.4.5.3 Records of calibration must be kept that provide an auditable link to specific batches of media and tests.

4.4.6 Balances

4.4.6.1 The balances must meet the accuracy requirements of the test being carried out.

4.4.6.2 Three yearly external calibrations must be performed by an accredited certification body.

4.4.6.3 Zero points are to be checked each time the balance is used.

4.4.6.4 A single point near the capacity of the balance must be checked monthly.

4.4.6.5 Repeatability readings must be carried out every 6 months.

4.4.6.6 Appropriate reference masses must be available and must be re-calibrated every 10 years.

4.4.6.7 Records shall be kept of all calibration data.

4.4.7 Thermometers

4.4.7.1 A reference thermometer with appropriate range and graduation must be available and re-calibrated every 10 years.

4.4.7.2 Working thermometers must be checked at ice point and in the working range on commissioning.

4.4.7.3 Ice point checks of all working thermometers must be carried ouevery 6 months.

4.4.7.4 Records shall be kept of all calibration data.

4.4.8 Incubators and Temperature Controlled Equipment

4.4.8.1 All incubators and temperature controlled equipment (ie freezers, refrigerators etc) must be monitored daily when in use.

4.4.8.2 Monitoring results must be recorded and readily available to staff. It is recommended that records are displayed on the equipment where possible.

4.4.8.3 All equipment shall be checked for spatial temperature variation on commissioning and after major repairs.

4.4.9 Autoclaves

4.4.9.1 Autoclave temperature and pressure gauges and timer must be calibrated annually.

4.4.9.2 Load profiles for typical loads must be determined.

4.4.9.3 Records shall be kept of autoclave cycles, including load type, temperature and time.

4.4.9.4 Indicators shall be used with each load to demonstrate correct operation.

4.4.10 Pipettors

4.4.10.1 Pipettors must be calibrated by weight using distilled water every 3 months. The acceptability criterion is ± 2%.

4.4.10.2 Sterile blanks should be included during testing to verify sterility.

4.5 Sampling

4.5.1 The laboratory shall have appropriate documentation and procedures for the collection, transportation, receipt, handling, protection, storage and disposal of samples.

4.5.2 The laboratory shall monitor sample conditions that may affect the validity of the test result, ie time between collection and analysis, temperature on arrival etc.

4.6 Assuring the quality of test results

4.6.1 The laboratory shall have appropriate documentation and procedures for monitoring the validity of test results including media quality control and verfication of test results.

4.6.2 The laboratory shall have a documented procedure for handling, preparation and use of control cultures. Control cultures for each test being performed must be included with each batch of tests or run at least daily.

4.6.3 The laboratory shall participate in external proficiency testing programs for all analytes where available, at a minimum frequency of oncy every 6 months.

4.7 Reporting of results

4.7.1 The laboratory shall have appropriate documentation and procedures for the reporting of results. This must include procedures for reporting results directly to AQIS at the same time that they are reported to the establishment management or submitting laboratory in the case of laboratories confirming tests results.

4.7.2 All reports issued by the laboratory should have as a minimum the following information:

• Unique report number
  
• Laboratory/Establishment name and AQIS number
  
• Date of report
  
• Identification of the method used
  
• Identification of any ambiguous conditions associated with the test
  
• Date of receipt of the sample including unique sample identification
  
• Date of testing
  
• Test results including units ie CFU/cm²
  
• Name and signature of the person authorising the report

4.7.3 If requested the laboratory can include in the report as needed opinions and interpretations. Justification for these opinions and interpretations shall be documented by the laboratory.