A revolution in the accountability and quality of food laboratory testing may be underway due to the Food Safety Modernization Act. Already, proposed regulations acknowledge the significant role laboratory testing plays in the detection and identification of microbiological and chemical hazards. They call for the use of verification testing, environmental monitoring, and product testing, and outline procedures to account for these activities. A section of the law calls for the recognition of laboratory accreditation and the development of model laboratory standards, all of which may set a new benchmark that all food laboratories must strive to meet.
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Microbiologics, a global provider of biological reference materials used in laboratory quality control processes, commissioned a third-party survey to ascertain the level of laboratory standards currently employed by food laboratories. The survey offered 186 food laboratory directors, quality assurance managers, and technical supervisors the opportunity to participate in an online survey. Surveys were sent to individuals working in laboratories within food manufacturing companies and to independent food laboratories. Individual responses are anonymous and Microbiologics only received results reported in the aggregate.
When asked where testing is conducted for their facility, 37 percent stated an onsite laboratory is used while 15 percent used a contract laboratory. A majority of respondents, 63 percent, used both an onsite and contract laboratory to meet their food testing needs.
These laboratories fulfill a wide range of testing needs. A majority of respondents, greater than 60 percent, indicated each of the following testing types are conducted by their laboratories: environmental monitoring, finished product testing, ingredient testing, raw material testing, verification testing, and validation testing.
Survey participants using onsite laboratories noted that only 42 percent of those laboratories are accredited, with the majority, 58 percent, not accredited. For those respondents using contract laboratories, 90 percent said that those laboratories are accredited, with 5 percent not accredited, and the remaining 5 percent unsure of the accreditation status.
Seventy-seven percent of the laboratory leaders stated that having laboratories accredited to an internationally-recognized standard, particularly ISO 17025, was important to them. Fifteen percent of the respondents were unsure if this was an important credential, and 8 percent stated that it was not important to them.
Upholding Quality Standards
Quality controls are used as part of a food laboratory’s processes and procedures to assure that its test methods are reliably detecting specific pathogens. Of survey respondents using onsite laboratories, 81 percent stated that their laboratory uses quality control materials as part of its testing processes and procedures. Twelve percent said that quality control materials were used sometimes, 4 percent stated that no quality control materials were used, and 4 percent did not know.
Of survey participants using contract laboratories, 67 percent stated that quality control materials were used. Almost a third (29 percent) were unsure if the contract laboratory used quality control materials, and 5 percent indicated that quality controls were used sometimes.
Proficiency testing, where a laboratory will receive and perform testing on unknown specimens from an impartial third-party source, is a form of external quality control.
Eighty-five percent of respondents stated that their onsite laboratory participated in proficiency testing, while about half (52 percent) of the contract laboratories did. The other half of the respondents (48 percent) stated that they did not know if their contract laboratory participated in proficiency testing. Fifteen percent of the onsite laboratories did not participate in proficiency testing.
Survey participants were asked what percentage of their laboratory staff is certified as food scientists or technologists. Certification of food scientists and technologists is offered as a credential from a limited number of professional societies and trade associations.
For onsite laboratories, nearly a third of survey participants stated that none of their laboratory staff are certified, another third indicated that about 20 percent of their staff are certified, and about 20 percent of respondents stated that they did not know if their laboratory personnel are certified. For contract laboratories, 90 percent of survey participants did not know if their laboratory staff are certified.
When asked to select each of the standards or processes their laboratory follows, participating laboratory leaders had a range of responses. All respondents (100 percent) follow AOAC, and 72 percent use the BAM (Bacteriological Analytical Manual). Between 30 to 50 percent of survey respondents use Hazard Analysis and Critical Control Points (44 percent), ISO 17025 (44 percent), Global Food Safety Initiative-recognized schemes (36 percent), Standard Methods Dairy (40 percent), and/or Standard Methods Water (40 percent). A handful of respondents indicated the use of Codex Standards (12 percent), ISO 11133 (4 percent), or ISO (other) (4 percent). Four percent indicated that they did not know which standards or processes are followed by their laboratory, and 16 percent noted “other” standards or processes, not listed.
A section of the law calls for the recognition of laboratory accreditation and the development of model laboratory standards, all of which may set a new benchmark that all food laboratories must strive to meet.
Fifteen percent, or 28, of the laboratory leaders contacted responded to the survey. No two respondents are from the same laboratory. The aggregate results provide a glimpse into the level and knowledge of laboratory standards currently employed by food laboratories.
Among the overall results, it is notable that over 60 percent of respondents utilize both onsite and contract laboratories for what appears to be a wide range of testing needs.
Although more than three-quarters of these laboratory professionals state that laboratory accreditation to an internationally-recognized standard is important to them, only 42 percent of onsite laboratories are reported as accredited. In contrast, 90 percent of the respondents’ contract laboratories are reported as accredited.
Among respondents using onsite laboratories, 81 percent stated that their laboratory uses quality control materials, and 85 percent reported using a proficiency testing program.
There is some uncertainty reported among respondents on the practices of contract laboratories. Twenty-nine percent were unsure if their contract laboratory used quality control materials, and almost half reported uncertainty as to if their contract laboratory participated in proficiency testing. Ninety percent of survey participants did not know if contract laboratory staff were certified.
Stombler is president of Auburn Health Strategies, LLC in Arlington, Va. Reach her at Rstombler@auburnstrat.com.
AUTHOR NOTES: Percentages presented in this report are rounded to the nearest whole number. This survey was made possible by Microbiologics and was produced by Auburn Health Strategies.