[From the Board] Processes and Results

Roger Brauninger discusses how validation ensures that all your food safety tests, whether run within a plant or external lab, are credible, accurate and thorough.

Ensuring that the foods you produce are safe for human consumption is a primary focus and responsibility of any food and beverage processing plant. To do so, a plant needs to ensure that all its food safety tests, whether run within a plant or external lab, are credible, accurate and thorough.

Just as many food plants rely on third-party auditing to gain confidence in the credibility of their own internal food quality, safety and defense processes and practices, so too do many laboratories choose third-party accreditation to provide confidence in the accuracy and assurance that their testing processes, practices and results have been generated by a competent facility.

TESTING TO ISO STANDARD. Accreditation of food-testing laboratories to ISO/IEC 17025 standards is a fairly recent development in an industry that has long been involved in safety testing and characterization. The ISO standard for quality control laboratories helps provide critical assurance to customers and the public that the food testing performed in these laboratories has been found to be technically competent by an independent third party.

According to the International Laboratory Accreditation Cooperation (ILAC), laboratory accreditation provides:

  • Recognition of Testing Competence. Accreditation helps determine a laboratory’s technical competence in performing specific types of testing, measurement and calibration, and offers a formal recognition of competence. It provides customers with a ready means of identifying and selecting reliable testing, measurement and calibration services to meet their needs.
  • A Benchmark for Performance. Since many such laboratories operate in isolation to their peers, and rarely, if ever, receive any independent technical evaluation as a measure of their performance, this enables laboratories to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence.
  • Customer Specification Fulfillment. Regarded as a reliable indicator of technical competence nationally and internationally, some retail and international customers specify that supplier product testing be conducted by an accredited lab.
  • International Recognition. Many countries have one or more organizations responsible for accrediting their nation’s laboratories. Most of these bodies have adopted ISO/IEC 17025 as the basis for accreditation, which has helped countries employ a uniform approach to determining laboratory competence and has encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible.

THE PROCESS. ILAC-recognized accreditation bodies generally approach the process in broadly similar ways, but each body has its own particular approach and sets of requirements for the laboratory to comply with beyond those required strictly by ISO 17025. The particulars are driven by the need for the accreditation body to themselves meet ISO/IEC 17011 that govern the operations of recognized ILAC accreditation bodies.

The process followed at A2LA provides an example of the steps to laboratory accreditation:

  1. The laboratory identifies the particular tests/procedures for which it wishes to be accredited, generates the required quality system documents, including SOPs and a quality manual, and if it doesn’t already do so, begins proficiency testing.
  2. When the application for accreditation is received, an assessor with the appropriate technical background is identified and the assessment is scheduled.
  3. After the assessment, the lab initiates corrective action for any deficiencies and provides objective evidence that any findings have been resolved.
  4. The lab’s assessment package is then sent to the Accreditation Council for review and balloting. A successful outcome of this balloting process means the lab is accredited.

This accreditation is valid for two years, with additional actions/activities required during that period. For newly accredited laboratories, a brief (usually one-day) assessment is required on the first anniversary date.

The purpose of this first-year annual review/surveillance assessment is to confirm that the laboratory’s quality system and technical capabilities remain in compliance with the accreditation requirements. To confirm this, the assessor reviews the documentation required for the laboratory’s organization and management, internal audit, management review, corrective/preventive actions, complaints, document review, training records, calibrations and any proficiency testing/repeatability studies. He or she also verifies that the corrective actions for any deficiencies cited during the initial assessment have been and continue to be implemented.

Unless there are extraordinary circumstances, this annual review information is reviewed by accreditation staff, and on-site visits are limited to a renewal assessment.

Validation of a food-testing laboratory’s processes and results is critical to ensuring the quality and safety of a company’s product. While accreditation is not the only way to verify a lab’s practices, it can provide processors with a third-party confirmation of a lab’s competence.

The author is senior accreditation officer, American Association for Laboratory Accreditation (A2LA), and a member of the QA Advisory Board.

February 2009
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