Documentation in the microbiology laboratory seeking accreditation

It is essential to establish a quality management system in a laboratory seeking accreditation against the ISO 17025:2005 International Standard. The quality management system brings the top management of the laboratory and its technical activities together through a documentation process and a series of practices. It provides information for the continuous improvement of the laboratory’s activities and identifies the responsibilities of individual staff members. The basic procedures behind a good quality management system are:

1) Documentation of methods for all management and technical operations

2) Practice of all operations as documented with no deviations

3) Documentation of the activities in the laboratory during performance

Strict adherence to these three procedures provides the basis for traceability, corrective actions and improvements in the performance of a testing laboratory. Some of the steps that a microbiological testing laboratory needs to take to become accredited are reviewed here. The laboratory is expected to prepare a quality manual and related technical documents (a technical manual) following the guidelines of the International standard. The quality manual needs to clearly identify the policies and procedures needed to implement each element in the management of the laboratory discussed below. For the convenience of the reader, this document uses the same sequenced and numbering system as the international standard.

4. Management Requirements
5. Technical Requirements
4.0 Management Requirements

The International Standard 17025:2005 expects laboratories to establish a management system that confirms the commitment of top management and documents procedures that will ensure that the laboratory operates, and continues to improve, according to internationally accepted norms, so that its test results are scientifically valid and universally acceptable. The key elements under management requirements are discussed below.

4.1 Organization

This section of the quality manual is expected to document the legal responsibility of the microbiology laboratory and its role of in relation to other functions of the organization. An organogram will be very helpful. It should document the responsibilities of the staff, including those of the quality manager and the technical manager and indicate how the laboratory will maintain its independence in making technical decisions.

4.2 Quality system

A laboratory quality system consists of documented policies, management systems, programs, tests and other related procedures and instructions for those who manage the delivery of quality test results. The document needs to highlight the chief executive’s quality policy on the following:

  • Management’s commitment to good professional practice and quality of testing in the service of clients.

  • A statement of the standard of service provided by the laboratory.

  • Objectives of the quality system.

  • A requirement that all the laboratory staff should familiarize themselves with quality documentation and implement the policies.

  • A statement that all testing shall use the methods in the manuals and meet the requirements of the clients.

  • The commitment of the laboratory management to comply with ISO 17025:2005.

The quality manual should have cross-references to the sections in the technical manual.

4.3 Document control

The quality manual, the technical manual, the standard operating procedures, and the formats and forms for keeping records constitute the controlled documents. They have a standard header and are approved by the top manager for use in the laboratory. They cannot be changed without his/her approval. A limited number of the manuals carrying the top manager’s stamp are made available to specified persons, and are never photocopied. The manuals provide the guidelines for all the laboratory’s managerial and technical procedures and decisions.

4.4 Review of requests, tenders, or contracts

This section address the documented policy and procedures to be used in handling, reviewing and meeting contractual agreements related to clients who obtain services from or provide them to the laboratory. It is meant to eliminate conflicts of interest. Records of all decisions are retained for future reference and action.

4.5 Subcontracting of tests

A laboratory needs to document its policy and procedures on subcontracting its tests, the conditions of entry into subcontracts and the use of test results from subcontractors in issuing test certificates. It should, in general, subcontract to laboratories of the same accreditation status or similar work standards. Test reports generated from subcontracting should be submitted to clients as separate documents.

4.6 Purchasing services and supplies

The laboratory needs to document its policy and procedures for evaluating the suppliers of services, equipment and consumables in order to maintain its quality standards and ensure the validity of its test results. This includes identifying the warranties, quality assurance certificates, calibration certificates, installation services and periodic checks requested from suppliers as part of purchase agreements, and getting technical clearance before payment is made.

4.7 Services to clients

Accredited laboratories are expected to keep up regular communication with their clients, pay prompt attention to their needs and maintain a good relationship with them. The policy and procedures for providing these services, without infringing on the interests of other clients, need to be documented under this section. The laboratory should make use of individual feedback from its clients, or from regular surveys to improve the performance.

4.8 Complaints

The laboratory needs to prepare an action policy and procedures to record, investigate and act on complaints from its clients or other parties regarding its test results. These procedures need to be documented with forms designed for logging and following up complaints.

4.9 Control of Nonconforming Testing

Evidence of nonconforming testing may appear from monitoring the trends in test results, performance checks on instruments, quality control activities, visual examination of microbiological media, observations of staff during supervision, checking of test certificates, internal or external audits, f inter-laboratory comparisons, proficiency testing, and in many other ways. They may be related to the technical operations or to the operation of the quality system. Procedures for handling such situations should be documented in the quality manual and should include:

  • Identification of management personnel responsible for taking action when non-conforming work is recognised.

  • Evaluating the significance of nonconforming work related to test results.

  • Deciding on the acceptability of nonconforming work.

  • Taking corrective actions, where necessary.

  • Recalling certificates and immediately notifying clients, where necessary.

  • Responsibility for authorizing resumption of work if it was stopped.

  • Follow up actions to ensure that the nonconformity does not recur.

4.10 Corrective actions

Corrective actions will be required when there is a departure from testing procedures, nonconforming work or weaknesses in the quality system. The policy and procedures to be documented for corrective action include:

  • Analyse the cause [Start actions to investigate the origin of the problem]

  • Decide on corrective action [identify and document the proposed corrective actions]

  • Implement corrective action

  • Monitor the outcome of the corrective action [Monitor the results to ensure that the corrective action has been effective]

  • Conduct additional audits [if the nonconformity was serious enough to affect the test results, an additional audit may be carried out to ensure that the system is now operating]

4.11 Preventive actions

Preventive action is a pro-active measure taken when potential problems are identified. The need for them may be recognized when operational procedures are reviewed, or after changes in services purchased, repeatability and reproducibility experiments, equipment performance checks, daily temperature records of equipment, analysis of data for trends, and proficiency test results. Policy and procedures to identify and handle preventive actions need to be documented.

4.12 Control of records

The laboratory is expected to keep coded and filed records of matters related to management and technical requirements. Records related to management requirements include:

  • Quality records.

  • Reports from internal audits.

  • Minutes of management review meetings.

  • Records of complaints.

  • Records of corrective actions

  • Records of preventive actions

Records related to technical activities need to show all the original data, calculations, checking of the calculations, derived data and the format in which the test reports or certificates were produced. The information should be written legibly, with any corrections done by crossing off the original entry and writing the new entry alongside it. The person making the correction should initial it. Most of the entries in the technical records are made during working and not later. They should be identifiable to the specific tasks, persons and test. Records should include:

  • Workbench record books /sheets

  • Check sheets

  • Quality control charts

  • Certificates

  • Calibration certificates

  • Temperature, humidity record charts

  • Test protocols

  • Sampling protocols

  • Media purchase documents with quality assurance certificates

  • Contract and tender documents

  • Cleaning records

  • Equipment files

  • Staff files

All these records should be coded and kept in the custody of management, especially when individuals resign from the laboratory, so that historical evidence can be provided of the laboratory’s performance.

4.13 Internal audits

A laboratory is expected to carry out planned internal audits on a regular basis as a means of identifying areas that need strengthening and corrective actions that need to be taken. These initiatives will generate the continuous improvement that is viewed positively in the accreditation process.

4.14 Management reviews

Annual management reviews are a proactive source of improvement in a laboratory. The review should include the following in its agenda:

  • The suitability of policies and procedures documented in the quality and operating manuals

  • New developments in testing that need to be incorporated into the system

  • Reports from managerial and supervisory personnel

  • The outcome of the recent internal audits

  • Corrective and preventive actions taken

  • Assessments carried out by external bodies

  • The results of inter-laboratory comparisons and proficiency testing

  • Changes in the volume and type of work

  • Client feedback

  • Complaints

  • Future needs of equipment and consumables

  • Staffing requirements and further training

  • lEfficiency of the quality control system

It is important that all these items should be included in the review agenda, discussed and decisions and responses recorded.

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5.0 Technical Requirements
5.1 General

This section identifies the technical requirements that should be met in a microbiological testing laboratory in order to minimize uncertainties arising during technical activities and to provide traceability. Strict adherence to these requirements contribute to the credibility of the laboratory.

5.2 Personnel

General guidance on the qualifications and job descriptions of staff in a microbiology laboratory is given elsewhere in this document. Employees of a microbiology testing are expected to be medically cleared for color blindness and any characteristics that would make them carriers of pathogenic microorganisms. Each employee is expected to train continuously so that they will be competent in new microbiology testing methods and concepts. Such training should be planned, documented and recorded.

5.3 Accommodation and environmental conditions

Microbiology testing laboratories are expected to provide physically separate space for testing, media preparation and decontamination functions as minimum preventives of cross contaminations during testing. The laboratory should be designed and activities organized in a way that will minimize the movement and presence of staff in aseptically maintained testing and media preparation areas. The air quality needs to be maintained under constant conditions (25-27 oC and around 60% RH) with regular monitoring on the microbial quality of the air. Records should show that these conditions are being maintained.

5.4 Test methods and method validation

When a laboratory seeks accreditation to carry out a given set of tests that it performs frequently it must demonstrate staff competency in performing them. The laboratory is expected to select test methods which are validated, published and internationally accepted. If modification of these methods is to be acceptable at accreditation, their validation must be shown. In using validated methods, the analysts are expected to demonstrate, at the time of seeking accreditation, competency gained through continuous practice of the methods. Guidance on the sources of microbiological test methods and validation are discussed elsewhere in this document.

5.5 Equipment

A laboratory is expected to contain only calibrated equipment in working order. It should provide an identification number for each item of equipment and maintain a file under this identification number. The file should provide information about the equipment: when it was received, its continuous calibration status, any problems observed, ay repairs carried out and the instructions followed to operate and maintain it.

5.6 Traceability of Measurement

A microbiology testing laboratory is expected to maintain traceability to the international system through calibration of autoclaves, balances, ovens, incubators, water baths, blenders, volumetric apparatus and thermometers. In addition, intermediate checks should be carried out on the performance of the measuring equipment and documented to provide evidence of continuous traceability.

In microbiological testing standard reference cultures need to be used to test the microbiological media for accuracy of performance, and to establish identity of microorganisms tested through comparison of colour reactions and other colony characteristics. Acquiring quality assurance certificates from the producers at the point of purchase of media helps to avoid detailed testing of media to prove their reliability using positive and negative cultures.

5.7 Sampling

The growth of microorganisms on solid food surfaces is not uniform. The acceptance – rejection criteria for foods contaminated with microorganisms require testing of several samples drawn according to sampling plans. The laboratory needs to maintain documented sampling procedures, persons trained in sampling and evidence of adherence to sampling practices under aseptic conditions if it is to seek accreditation in this area.

5.8 Handling test items

Handling foods for microbiological testing requires special attention if the validity of the sample is to be retained up to the point of testing. This requires using stipulated storage temperatures, testing within 36 hours of sampling and finally disposing of all the test material only after it has been autoclaved and incinerated to avoid public health hazards. A laboratory is expected to establish and document handling procedures to be used throughout the process and to provide documentary evidence of strict adherence to these procedures.

5.9 Assuring quality of test results

The laboratory needs to establish its own quality control procedures to monitor the validity of tests aimed at detecting trends, carry out statistical analysis of test results and compare different test results. Trends should be examined along with observations of the following and any other relevant criteria.

  • Air quality and water quality monitoring

  • Results of interlaboratory comparisons and proficiency test results

  • Results of experiments used to establish repeatability and reproducibility

  • Use of standard and reference cultures

  • Performance checks on equipment

  • Equipment calibrations

  • Quality of microbiological media used

  • Any other relevant information

Any information derived from these activities should be used to take preventive and corrective actions, with appropriate records.

5.10 Reporting test results

The laboratory documentation system should be able to provide evidence of traceability from the test reports backward to the origin of the data at the workbench, in the preparation of reagents and media, or in sample handling, although the test report contains only derived data. The test report may contain interpretations requested by the client and signed by the technical manager.

To maintain its accreditation status, a laboratory must adhere strictly to the guidelines of the International Standard, maintaining proper work records and demonstrating its commitment to improvement.

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