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Dairy Products Safe and True
Part B Standards
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General Requirements for the Competence of Category 2 Laboratories (Superceded)
Note: Sections are numbered as in ISO/IEC Guide 25, on which this Standard is based. Requirements printed in italics do not apply until 1 July 1993.
1.1 This Standard sets out the general requirements in accordance with which a Category 2 laboratory has to demonstrate that it operates if it is to be recognised as competent to carry out specific tests.
1.2 Additional requirements and information which have to be disclosed for assessing competence or for determining compliance with other criteria may be specified by the organisation or authority granting the recognition or approval, depending upon the specific character of the task of the laboratory.
Comment: Additional requirements are noted beside appropriate sections below. Requirements may also be issued from time to time in MAF Reg Dairy Circulars.
1.3 This Standard is for use by testing laboratories in the development and implementation of their quality systems. It may also be used by accreditation bodies, certification bodies and others concerned with the competence of laboratories.
Comment: Audit of Category 2 laboratories will be based on this Standard.
This Standard is based on ISO/IEC Guide 25:1990.
3.1. Laboratory: A body that carries out tests and/or calibrates equipment.
Comment: In cases where a laboratory forms part of an organisation that carries out other activities besides testing, the term "laboratory" refers only to those parts of that organisation that are involved in the testing process.
The laboratory may be at a permanent location, or a temporary facility, or a mobile facility.
Category 2 laboratory: A laboratory registered by MAF Reg to test only for internal quality control purposes (including raw milk testing) and product for the company's own domestic market.
3.4 Calibration: The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system and known values.
Comment: The result of a calibration allows you to estimate errors of measurement.
3.5 Test: An operation that determines one or more characteristics of a sample using a specified procedure.
Comment: The result of a test is normally recorded in a document sometimes called a test report or a test certificate.
3.6 Calibration method: Defined technical procedure for performing a calibration.
3.7 Test method: Defined technical procedure for performing a test.
Comment: Approved test methods are in manuals DDM 3, Microbiology, MQD 4, Chemistry, and MQD 10, Milk Appraisal. Selected approved methods for milk stations are published in MQD 12, Market Milk Code of Practice.
3.8 Verification: Confirmation by examination and provision of evidence that specified requirements have been met.
Comment: When calibrating measuring equipment, verification is the check that the differences between values indicated by an instrument and corresponding known values are consistently smaller than the maximum allowable error defined in the standard for the equipment.
The result of verification leads to a decision either to restore to service, or to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed be kept on the measuring instrument's individual calibration record.
3.9 Quality system: The organisational structure, responsibilities, procedures, processes and resources for implementing quality management.
3.10 Quality manual: A document stating the quality policy, quality system and quality practices of an organisation.
Comment: The quality manual may make reference to other documentation relating to the laboratory's quality arrangements.
3.11 Reference standard: In the context of this Standard the reference standard is identified as a "Standard Thermometer" or standard weights whose values are certified using a technically valid procedure by a certifying body.
3.12 Reference material: A material or substance one or more properties of which are sufficiently well established to be used for the assessment of a measurement method.
3.13 Traceability: The ability to relate a measurement to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.
3.14 Proficiency testing: Determination of the laboratory performance by means of inter-laboratory comparisons.
Comment: Interlaboratory comparisons could be an organised ILCP if it is available, or analysis by two or more laboratories of an independently taken audit sample.
4. Organisation and Management
4.1 The laboratory shall be legally identifiable. It shall be organised and shall operate in such a way that its permanent, temporary and mobile facilities meet the requirements of this Standard.
Comment: The legal identity is the name of the owner given in the laboratory's registration certificate.
4.2 The laboratory shall:
a) have managerial staff with the authority and resources needed to discharge their duties;
Comment: A person must have charge of the laboratory who has been given control over the accommodation, equipment, budget and staff necessary to carry out the tests for which it is registered.
b) have arrangements to ensure that its personnel are free from any commercial, financial and other pressures which might adversely affect the quality of their work;
c) be organised in such a way that confidence in its independence of judgement and integrity is maintained at all times;
Comment: There must be no way in which the manufacturing part of the organisation can influence the outcome of the tests.
d) specify and document the responsibility, authority and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations and tests;
Comment: The arrangements made to comply with the earlier sections must be recorded in writing.
e) provide supervision by persons familiar with the calibration or test methods and procedures, the objective of the calibration or test and the assessment of the results. The ratio of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision;
f) have a technical manager (however named) who has overall responsibility for the technical operations;
g) have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources, and to the technical manager. In some laboratories, the quality manager may also be the technical manager or deputy technical manager;
Comment: The laboratory must be managed by someone who thoroughly understands the tests being carried out. They must understand the principles on which the test works, what could go wrong and how to identify and correct any problems, and who is responsible for the results.
h) nominate deputies in case of absence of the technical or quality manager;
i) where relevant, have documented policy and procedures to ensure the protection of clients' confidential information and proprietary rights;
Comment: Clients are those for whom the laboratory produces test reports, and include MAF Reg.
j) participate in inter-laboratory comparisons and proficiency testing programmes.
Comment: MAF Reg has specified that laboratories must take part in ILCP for all tests for which it is available and must organise some independent sampling (see 10.5) and duplicate testing in another registered lab. Details of the ILCP are in MQD 12, Market Milk Code of Practice, Part G.
5. Quality System, Audit and Review
5.1 The laboratory shall establish and maintain a quality system appropriate to the type, range and volume of testing activities it undertakes. The elements of this system shall be documented. The quality documentation shall be available for use by the laboratory personnel. The quality manual shall be maintained current under the responsibility of the quality manager.
Comment: The quality documentation does not need to be elaborate but someone must be responsible for writing and keeping up to date the procedures and records which are necessary to produce results that mean something.
5.3 The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements of the quality system. Such audits shall be carried out by trained and qualified staff who are, wherever possible, independent of the activity to be audited. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibration or test results, the laboratory shall take immediate corrective action and shall immediately notify, in writing, any client whose work may have been affected.
Comment: For a small laboratory it is acceptable for the annual external audit to be the only audit. The audit may be carried out by a single auditor.
5.4 The quality system adopted to satisfy the requirements of this Standard shall be reviewed at least once a year by the management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements.
Comment: This review is independent of the audit though obviously the audit report would be part of the information considered.
5.5 All audit and review findings and any corrective actions that arise from them shall be documented. The person responsible for quality shall ensure that these actions are discharged within the agreed timescale.
5.6 In addition to periodic audits the laboratory shall ensure the quality of results provided to clients by implementing checks. These checks shall be reviewed and shall include, as appropriate, but not be limited to:
a) internal quality control schemes using whenever possible statistical techniques;
b) participation in proficiency testing or other interlaboratory comparisons;
c) replicate testings using the same or different methods.
Comment: Quality control checks should be part of the method for most tests. They include the use of positive and negative controls, standards, duplicates, house standards, checks on water quality and pH for media preparation and the like. They demonstrate the credibility of the test result. More details are contained in MQD 12, Market Milk Code of Practice, Part F, and in the documents listed under "Further Information".
6.1 The testing laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.
6.2 The testing laboratory shall ensure that the training of its personnel is kept up-to-date.
6.3 Records on the relevant qualifications, training, skills and experience of the technical personnel shall be maintained by the laboratory.
Comment: The people who are doing the testing should understand what they are doing or at least should be under the direct supervision of someone who does. This could be the result of informal, in-house training and does not mean that every person involved in testing has to have a formal qualification.
7. Accommodation and Environment
7.1 Laboratory accommodation, test areas, energy sources, lighting, heating and ventilation shall be such as to facilitate proper performance of calibrations or tests.
Comment: The laboratory must be housed and run in such a way that the conditions do not invalidate the results. More details are in MQD 12, Market Milk Code of Practice, Part G, Appendix III.
7.2 The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.
7.3 The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, mains voltage, temperature, and sound and vibration levels, as appropriate to the calibrations or tests concerned.
Comment: The laboratory should make and record measurements of those factors, like temperature and bacterial air counts, which might affect the results and take action if the trigger levels are exceeded.
7.4 There shall be effective separation between neighbouring areas when their activities are incompatible.
Comment: It may be necessary to separate off some areas, such as microbiology laboratories.
7.5 Access to and use of all areas where the quality of the testing could be affected shall be defined and controlled.
Comment: Only authorised people should be able to enter the testing areas.
7.6 Adequate measures shall be taken to ensure good housekeeping in the laboratory.
Comment: It is the laboratory's responsibility to comply with the relevant health and safety requirements. This aspect, however, is outside the scope of the Standard.
8. Equipment and Reference Materials
8.1 The laboratory shall have all items of equipment (including reference materials) required for the correct performance of calibrations and tests. In those cases where the laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements of this Standard are met.
Comment: A laboratory should have all the equipment necessary to carry out testing and calibration. Approved equipment for some tests is listed in MQD 12, Market Milk Code of Practice, Part F.
8.2 All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests.
Comment: The laboratory should be able to show that the equipment is working properly and should have a system for dealing with equipment which is not working.
8.3 Records shall be maintained of each item of equipment and all reference materials significant to the calibrations or tests performed. The records shall include:
a) the name of the item of equipment;
b) the manufacturer's name, type identification, and serial number or other unique identification;
c) date received and date placed in service;
d) current location, where appropriate;
e) condition when received (e.g. new, used, reconditioned);
f) copy of the manufacturer's instructions, where available;
g) dates and results of calibrations and/or verifications and date of next calibration and/or verification;
h) details of maintenance carried out to date and planned for the future;
i) history of any damage, malfunction, modification or repair.
Comment: Records should be kept of the preparation, use and storage of standard reagents and microbiological media.
The result of a calibration should be recorded in such a way as to identify the equipment calibrated.
9. Measurement, Traceability and Calibration
9.1 All measuring and testing equipment having an effect on the accuracy or validity of calibrations or tests shall be calibrated and/or verified before being put into service. The laboratory shall have an established programme for the calibration and verification of its measuring and test equipment.
Comment: All equipment that makes measurements which are an important part of the test must be calibrated, against a standard traceable to a national standard when possible.
9.2 The overall programme of calibration and/or verification and validation of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available. Calibration certificates shall wherever applicable indicate the traceability to national standards of measurement and shall provide the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified metrological specification.
9.3 Where traceability to national standards of measurement is not applicable, the laboratory shall provide satisfactory evidence of correlation of results, for example by participation in a suitable programme of interlaboratory comparisons or proficiency testing.
9.4 Reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated.
9.5 Reference standards of measurement shall be calibrated by a body that can provide traceability to a national standard of measurement. There shall be a programme of calibration and verification for reference standards.
9.6 Where relevant, measuring and testing equipment shall be subjected to in-service checks between calibrations and verifications.
Comment: Routine checks should be made from time to time where the measurement is known to change (e.g. electronic thermometers).
10. Calibration and Test Methods
10.1 The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of items and for calibration and/or
testing, where the absence of such instructions could jeopardise the calibrations or tests. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be maintained up-to-date and be readily available to the staff.
10.2 The laboratory shall use appropriate methods and procedures for all calibrations and tests and related activities within its responsibility (including sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration and/or test data). They shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations or tests concerned.
10.3 Where methods are not specified, the laboratory shall, wherever possible, select methods that have been published in international or national standards, those published by reputable technical organisations or in relevant scientific texts or journals.
Comment: The test methods should be up to date and available to anyone carrying out the test. They should be clear and should include such things as the variability (so that results are not reported with a spurious accuracy and the tester knows when a result could be close to a test limit). Methods should be acceptable to MAF Reg, either those given in MQD 12, Market Milk Code of Practice, Part F, or by direct agreement. Any changes to the method should be justified and agreed before they are used.
10.4 Where it is necessary to employ methods that have not been established as standard, these shall be subject to agreement with the client, be fully documented and validated, and be available to the client and other recipients of the relevant reports.
Comment: Methods of calibrating laboratory equipment are given in MQD 12, Part F, and calibrating thermometers, in MQD 12, Part C.
10.5 Where sampling is carried out as part of the test method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples.
Comment: Sampling is an important part of the testing process. The way the sample is taken and handled can critically affect the test. It is the laboratory's responsibility to make its best efforts to be sure that the sample accurately represents the lot being tested.
The method of sampling and handling samples should be recorded especially those features that could affect the outcome of the test. Methods of sampling are given in MQD 12, Market Milk Code of Practice, Parts E and F.
10.6 Calculations and data transfers shall be subject to appropriate checks.
Comment: Where the method requires recording measurements and making calculations the laboratory should have a system to check that mistakes have not been made. This means that a second person should redo a proportion of the calculations and check transcriptions.
10.7 Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration or test data, the laboratory shall ensure that:
a) the requirements of this Standard are complied with;
b) computer software is documented and adequate for use;
c) procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity of data entry or capture, data storage, data transmission and data processing;
d) computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of test data;
e) it establishes and implements appropriate procedures for the maintenance of security of data including the prevention of unauthorised access to, and the unauthorised amendment of, computer records.
11.1 The laboratory shall have a documented system for uniquely identifying the items to be calibrated or tested, to ensure that there can be no confusion regarding the identity of such items at any time.
Comment: All samples must be identified in some way which prevents confusion with other samples. Repeat samples must be given a separate identification to avoid confusion.
11.2 Upon receipt, the condition of the test item, including any abnormalities or departures from standard condition as prescribed in the relevant test method, shall be recorded. Where there is any doubt as to the item's suitability for test, where the item does not conform to the description provided, or where the test required is not fully specified, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory.
Comment: Where the laboratory has no control over sampling it should still be aware of the condition of the sample it receives and should be careful how the samples are handled and stored. Reports should make it clear that the results relate only to the sample as received.
11.3 The laboratory shall have documented procedures and appropriate facilities to avoid deterioration or damage to the test item, during storage, handling, preparation, and test; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a test item or
portion of an item is to be held secure (for example, for reasons of record, safety or value, or to enable check tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned.
Comment: The tester must be sure that the sample is in good condition and that the results of the test are not likely to be falsified by the condition of the sample. If the sample is to be kept for a length of time that may lead to deterioration, the laboratory should have the facilities to keep it without any problems, for example in a refrigerator or freezer. Details are given in MQD 12, Parts E and F.
11.4 The laboratory shall have documented procedures for the receipt, retention or safe disposal of test items, including all provisions necessary to protect the integrity of the laboratory.
Comment: The laboratory must have procedures for getting rid of samples and test materials safely. See MQD 12, Part F, Section 7.1.
12.1 The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. It shall retain on record all original observations, calculations and derived data, calibration records and a copy of the test report for an appropriate period. The records for each test shall contain sufficient information to permit their repetition. The records shall include the identity of personnel involved in sampling, preparation, calibration or testing.
Comment: Requirements for record keeping are in MQD 12, Part F, Section 4. The laboratory must keep all their laboratory results, including the measurements and calculations made during the test. Any changes should be made by crossing through, but not obliterating, the original result. The change should be initialled and the reason for the change recorded.
12.2 All records including those listed in 8.4 pertaining to test equipment, certificates and reports shall be safely stored, held secure and in confidence to the client.
Comment: Records of calibration must be kept.
13.1 The results of each test, or series of tests, carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, in accordance with any instructions in the test methods. The results should normally be reported in a test report and should include all the information necessary for the interpretation of the test results and all information required by the method used.
Comment: Test results must be recorded in a way that is easily understood by the person using them. The person should know when the sample was received, when the test was done, which sample was tested, what tests were done, who tested it and what the result was. If there is a pass/fail limit it should be noted alongside the result.
Requirements for reporting to MAF Reg are in MPD-Stan 2, attached to Dairy Policy Circular No 5.
Requirements for reporting milk testing results are in MQD 12, Part F, Section 4.2.
13.2 Each certificate or report shall include at least the following information:
a) unique identification of the certificate or report (such as serial number) and of each page, and the total number of pages;
b) description and unambiguous identification of the item calibrated or tested;
c) date of receipt of test item and date(s) of performance of test, where appropriate;
d) identification of the test method used, or unambiguous description of any non-standard method used;
e) any deviations from, additions to or exclusions from the calibration or test method, and any other information relevant to a specific test, such as environmental conditions;
f) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified;
g) a statement of the estimated uncertainty of the test result (where relevant);
h) a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the report (however produced), and date of issue.
13.3 Where the report contains results of tests performed by sub-contractors, these results shall be clearly identified.
13.4 Particular care and attention shall be paid to the arrangement of the report, especially with regard to presentation of the test data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of test carried out, but the headings shall be standardised as far as possible.
13.5 Material amendments to a test report or test certificate after issue shall be made only in the form of a further document, or data transfer including the statement "Supplement
to Test Report (or Test Certificate), serial number ... [or as otherwise identified]", or equivalent form of wording. Such amendments shall meet all the relevant requirements of clause 12 of this Standard.
Comment: If a report needs to be changed for some reason it should be done on a separate report rather than an alteration of the original. The replacement report should have all the same features as the original plus the reason for the change and should refer to the original.
Further Information
The following documents contain further information that may assist laboratories in complying with this Standard:
Telarc Technical Guide Number 7. Quality Manuals for Testing Laboratories. Telarc New Zealand, 1991. Description and suggested format of a laboratory quality manual.
Specific Criteria Schedule No. 1. Dairy Testing Laboratories. Telarc New Zealand, 1992. Specific requirements for Telarc registration of dairy testing laboratories, with calibration and quality control procedures.
F.M. Garfield. Quality Assurance Principles for Analytical Laboratories. Second Edition. AOAC International, 1991. A handbook for initiating or improving a laboratory quality assurance programme.
R.S. Burrow, R.I. Hall and R.C.K. Leong. Guidelines for Good Laboratory Practice. MAF Dairy Division Technical Report T2/85, November 1985. Covers maintenance and calibration of equipment, control of microbiological media, chemical reagents and glassware, and critical points in chemical test methods.
Revision Status
Rev Date Status By Approved 1 8 February 1993 Issued for use MAF Reg (Dairy)
New Zealand Food Safety Authority
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