International Pesticide Product Registration Requirements

Chapter 24

Quality Assurance for Environmental Laboratories in Canada 1

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Richard Turle , Neil McQuaker , and Rick Wilson

Downloaded by NORTH CAROLINA STATE UNIV on September 23, 2012 | http://pubs.acs.org Publication Date: June 16, 1999 | doi: 10.1021/bk-1999-0724.ch024

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Environmental Technology Centre, Environment Canada, Ottawa, Ontario K1A 0H3, Canada Canadian Association of Analytical Laboratories, Suite 300, 265 Carling Avenue, Ottawa, Ontario K1S 2E1, Canada

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Canada has developed a national quality assurance system, based on ISO Guide 25, to provide accreditation and certification to laboratories that provide analytical systems data. The certification for key environmental parameters is based on the analysis of proficiency samples. This system involves two partners, the Standards Council of Canada as the accrediting body and the Canadian Association of Environmental Analytical Laboratories as the program provider. This system has been effective in meeting the demands of regulators and commercial clients.

There are a number of characteristics of a quality management system for laboratories engaged in primarily routine analysis that are essential to its optimal design and successful implementation. Such characteristics may in some aspects be different from those laboratories engaged in GLP protocol driven testing where the effort is directed to exhaustive testing of a single compound or product. Key among these essential characteristics is that the system should apply to all types and sizes of laboratories. Many laboratories attached to field testing stations or industrial plants are often quite small and cannot afford a full time quality assurance officer, for example. Other important characteristics are as follows: •

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The system should apply equally to both private and public sector laboratories. This ensures that there will be no hiding within the bureaucracy of a laboratory that cannot meet the requirements of the quality system. For example, the system may allow that in public sector laboratories the need for confidentiahty is less important than in a private sector laboratory, especially one under an Access to Information Act or similar legislation.

© 1999 A m e r i c a n C h e m i c a l Society

In International Pesticide Product Registration Requirements; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1999.


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The system should be recognized nationally, in all jurisdictions and by all levels of government, industrial trade associations and professional bodies. Such a national system should also follow internationally recognized standards.

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Finally, any laboratory engaged in routine testing should also participate in proficiency testing schemes based on, as much as possible, using real samples.

Accreditation. Many governments and other bodies run accreditation schemes for a variety of purposes including laboratory performance. In today's world, where environmental and regulatory decisions demand data of high and known quality, accreditation gives laboratories the recognition that they are capable of producing quality data on the tests described in their scope of accreditation. What are the requirements for accreditation? Summarized, they are: • • • • •

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a full or part time quality assurance officer; a quality manual, describing the laboratory and outlining policies a methods manual containing all routine procedures Standard Operating Procedures, including those for modification of methods, corrective procedures, and non-conformances to the quality manual participation in proficiency testing (certification) schemes and other interlaboratory comparisons (round-robins) to demonstrate competency to perform routine tests a site inspection or audit every two years.

Certification. Certification is recognition that a laboratory has actually analyzed blind samples and has met the requirements in terms of both accuracy (bias) and precision. Generally, a certificate is awarded for either a single test (e.g., pH, total PCBs) or for a group of tests (e.g., PAHs in soil, anions on air filters). A good certification program will demand that blind samples be run at least twice a year. The submitted results are compared to either a reference value, if a Certified Reference Material is used, or to a consensus mean. Points can be assigned on the basis of "acceptable deviation" from the accepted value. A score of 70% or more is required on two successive rounds to maintain the certificate of proficiency. Coupled with accreditation, certification provides further confidence that a laboratory can indeed perform quality test procedures. It is possible in Canada to be certified without being accredited but experience indicates that most laboratories which enter the certification program receive accreditation within two years. Perspectives on Laboratory Accreditation There are many perspectives on the value of lab accreditation depending on whether one is a laboratory practitioner or a user of laboratory data.



202 The Laboratory Manager's Perspective. The introduction of a quality system brings about a "cultural change" into the laboratory. Apartfromthe obvious pride in obtaining the certificate of accreditation, there is a change in attitude. This leads to doing itrightthefirsttime. This attitude also accepts that errors - nonconformances in the language of accreditation - will occur but that the lesson will be learned or the situation will be corrected. Inevitably, this reduces errors to the absolute minimum. This pride in doing the job right leads to a continuous improvement in procedures. Since procedures must be evaluated at least every two years. Consistency is thus ensured because no change is made without consultation and review. Further, written procedures can help define, hasten and improve laboratory training programs. All of these improvements lead to both tangible and intangible benefits for the productivityconscious laboratory manager. The Commercial Laboratory's Perspective. The possession of accreditation leads to more business opportunities whether or not the testing is required by a regulator for environmental assessments, contaminated site clean up, or for other commercial purposes. Accreditation and, if appropriate, the participation in a suitable proficiency testing program increasingly is written into contracts to testing organizations by private companies as well as governments. The Laboratory Client's Perspective. Accreditation provides to the client a third party assessment of the laboratory's capability and performance. The proficiency testing reports indicate whether the laboratory can perform the desired tests competently. The site assessment reports will identify problem areas and also indicate steps the laboratory has taken over and above that required to obtain accreditation. Finally businesses, who have to satisfy ISO 9000 requirements, can do this by using an accredited laboratory meeting ISO Guide 25 standards. The Regulator's Perspective. The regulator, by insisting that only accredited and, where appropriate, certified laboratories perform testing for a given regulation, is defining that as a minimum standard for the group of laboratories so affected. This gives him the assurance that laboratories operating out of kitchens or garages will not be providing vital results. He will know that the laboratories are using written test procedures and that there is an applicable set of Standard Operating Procedures. This reduces the cost of compliance auditing and inspection of laboratories. International Recognition The key to international recognition for laboratory accreditation is ISO Guide 25 (/). ISO Guide 25 is increasingly used as a basis for analyses required for trade. Both the Canadian and Mexican accreditation systems are based on it,as well as the developing National Environmental Laboratory Accreditation Conference (NELAC) program of the USEPA (2). Analytical data comingfroma laboratory accredited to ISO Guide 25 standards will meet minimum defined standards for quality. This results in acceptance


203 of data between governments and across borders. As environmental problems are becoming more global in scope, this will become even more essential.


The Canadian Association of Environmental Analytical Laboratories (CAEAL) CAEAL is a not-for-profit organization which exists for the purpose of promoting quality in environmental laboratories. The need for such an organization was recognized by both public and private laboratories to dispel the notion that laboratories were generating data of disparate quality. The only solution was to require laboratories to produce verifiable data of laboratory performance within an accreditation scheme. Established in 1989, the organization has grown and developed to become recognized internationally as an example of an effective national accreditation body. The Board consists of representatives elected from both government laboratories (including federal, provincial and municipal) as well as the private (for-profit) sector. In most jurisdictions in Canada there is no legal requirement to be accredited though at least one province, Newfoundland, requires it for results submitted to the provincial Department of the Environment. Other jurisdictions are actively considering accreditation as a requirement. CAEAL elements. This is a national program, open to laboratories in every province. However, in the province of Quebec, the Ministère del Fenvironnment et faune operates its own scheme (3), which also meets ISO Guide 25 requirements. Although the CAEAL program is based on ISO Guide 25, laboratories also must meet the requirements of a unique Canadian standard for environmental analytical laboratories, namely CAN/CSA-Z753-95 (4). The program requires that laboratories must also participate in CAEAL and other proficiency testing programs if they are applicable to the laboratories' scope of testing. There is also a requirement that each laboratory receives a site audit which comprises an examination of the quality manual and the testing and quality assurance procedures and includes a trace of selected samples through the testing procedures. All CAEAL auditors are trained to international standards. About 90 laboratories are now part of the SCC/CAEAL accreditation program. This constitutes about half of all the laboratories accredited in Canada. These include most federal and provincial laboratories and a few municipal laboratories. Most private sector environmental laboratories outside of Quebec have received accreditation through SCC/CAEAL. The growth is now occurring in the industrial sector as businesses recognize that their own laboratories should meet international standards. CAEAL certification program. The program consists of chemical analyses on a variety of sample types but mainly water. The program covers analyses for major cations, anions and trace metals in water and on airfilters,organochlorine pesticides, polycyclic aromatic hydrocarbons, volatile organic compounds in water, PAHs in soil, and PCBs in oil, as well as coliform, daphnia, trout and Microtox toxicity tests. Four samples are analysed twice a year. A scheme of acceptable deviation from the reference or consensus mean is calculated. A perfect score gives a rating of 100. To


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maintain the laboratory's status in the program a score of no less than 70 must be attained in each round of testing. Currently there are over 160 laboratories participating in this program. Environment Canada. This is the environmental agency of the Canadian federal government. It has supported CAEAL since inception by providing auditors and technical assistance. It was felt by senior management that by supporting a nongovernmental laboratory organization, it could be eventually selffinancing,which has indeed happened. Further, the amount of work required for compliance activities would be reduced if Environment Canada could be assured that the laboratory community as a whole was producing reliable data. This again has indeed happened. Similar support was obtained from the Ontario Ministry of Environment and Energy for similar reasons. Environment Canada requires accreditation for laboratory work it contracts to the private sector. Further, its operational laboratories are accredited. Standards Council of Canada and CAEAL The SCC is the body legislated by the Canadian parliament to develop national standards in Canada. It represents Canada at the International Standards Organization (ISO). It accredits laboratories under the Program for Accreditation of Laboratories in Canada (PALCAN) which includes those recommended by CAEAL. The SCC is starting to develop mutual recognition agreements with other national organizations. In this regard, there is a strong desire by Canadian companies and governments to see a North American-wide Mutual Agreement to complement the work undertaken by NAFTA. The SCC and CAEAL signed an agreement to enhance and develop the initial program. CAEAL recommends laboratories to the SCC which meet the CAN/CSA Z753. The SCC then grants accreditation to environmental laboratories for the tests they have specified in their application. The SCC promotes the use of accredited laboratories by publishing a list of laboratories biannually (5). This unique partnership has strengthened both organizations. It has meant that laboratories which had to be accredited by both organizations can now receive a joint site inspection and a single certificate of accreditation. The SCC benefits by having a larger pool to draw on for input into new or revised standards such as ISO Guide 25. For CAEAL, it will mean that there will be no need to develop its own mutual recognition agreements once the SCC develops such agreements. What of the future? It is anticipated that there will be a slow but gradual increase in the number of laboratories accredited under the SCC/CAEAL program. Growth is most likely in the municipal and industrial sectors. We anticipate expansion of the certification program as it becomes possible to add suitable chemical parameters (e.g., mercury arsenic and selenium). There is a need for a dioxin proficiency sample program. We also see collaboration between CAEAL and regulating bodies such as Environment Canada to


205 develop methods such as one for all types of petroleum hydrocarbons in contaminated soil. Literature Cited 1.


2. 3. 4. 5.

ISO Guide 25: 1990, General Requirements for the Competence of Calibration and Testing Laboratories. Analytical Chemistry News and Features, October 1, 1997, 589A. Programme d'accreditation des laboratoires d'analyse environne Quebéc Ministère de l' environnement et de la faune, 1994. CAN/CSA-753-95, Requirements for the Competence of Environm Laboratories, Canadian Standards Association, Rexdale, (Toronto) 1995. Directory of Accredited Calibration and Testing Laboratories, CAN-PStandards Council of Canada, 1996.


International Pesticide Product Registration Requirements

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