Debating the Value of Third-Party Audits
Here is Munyon’s letter to the food industry as posted on the Manhattan, Kan.-based group’s Web site followed by AIB’s white paper about the third-party auditing system.
“Over the past several months, there has been an ongoing and important debate in the United States between government and regulatory bodies and food manufacturers and retailers and their representatives regarding the value of the role played by third-party, food audit programs in securing a safe food supply,” Munyon writes.
”AIB has prepared a document, which we believe summarizes the most pertinent arguments in favor of such audits. The document concludes by addressing the AIB GMP audit program specifically and attempts to provide clarity regarding how our audits are scored, the nature of announced and unannounced audits and the appropriateness of a direct fee-paying relationship between audit providers and their clients.
”AIB International,” he adds, “is committed to the notion of a strengthened the Food and Drug Administration and its Integrated Food Protection Plan, as published in November 2007. This plan, in one of its many proposals, seeks to authorize FDA to accredit highly qualified third parties for voluntary food inspections.
”We look forward to continued participation in the debate,” he notes.
Here is AIB's report explaining “The Value of Third Party Audits.”Third-party audits provide an invaluable component to the safety of the U.S. food supply system. Multiple independent companies and audit programs provide literally thousands of independent checks and balances to the food supply system with no direct cost to taxpayers.
These audits are voluntary tools of the food manufacturer and are not meant to replace regulatory inspections. Usually, audits do not include microbiological sampling. However, a representative review of microbiological test records is part of the program evaluation. As a voluntary activity with no legal status, the audits depend on openness and disclosure to accomplish their full function. They are not meant to uncover deceit or fraud.
They are best described as professional service – a consultation activity that the facility can take advantage of the recommendations in full, in part or not at all. The deficiencies observed in the audit report can be resolved to the satisfaction of the facility or the buyer of product from the facility through pre-arranged agreements or program enhancements. Examples would include announced or unannounced visits, reports to all interested parties and follow up to resolve deficiencies through a variety of reporting methods.
The food industry uses audits in a number of ways to supplement food safety programs as a manufacturer of food, the distribution of input or output or a purchase of an ingredient, packaging suppliers or finished products.
One of the uses of third-party audits is the training component for new and existing employees responsible for the actual day-to-day execution of the facility’s food safety program. Responsible personnel are encouraged to accompany the auditors/inspectors during the audit as well as the closing session. The training component is particularly important to small and medium size companies without a large corporate staff.
In addition, the standards and the experience of the entire organization is part of the transmission of best practices to each and every processing facility involved. The motto of the food industry is that there are no secrets when it comes to food safety best practices – the entire industry benefits.
Third-party audits also provide an opportunity to recalibrate a facility’s own self-inspection, part of a standard food safety program requirement.
Additionally, these audits can provide a new set of eyes to view the operation, without the natural familiarity that occurs over time with regular staff in the day-to-day routine.
Finally, audits may be a component of a supplier approval program among companies. Other components may include certificate of analysis, independent lab analysis, transactional requirement and a plant visit, as well as other components to ensure a safe and predictable supply to the purchasing organization.
AIB GMP reports are content-rich, with an average of 68 comments and observations, and they typically run an average of 10-20 pages. The AIB GMP standards consider more than 300 elements under five categories. In recent years, the total number of observations for improvements offered and reported exceeds 150,000 per year in the United States alone.
Score of AIB GMP AuditScoring is based on observation of deficiencies against the standard being used and reported in five categories.
Therefore, only a score of 1000 would indicate no significant opportunity for improvement against the GMP requirements.
In addition to the score and its relative deficient observations, the report clearly states whether the audit was announced or unannounced.
In addition, even a facility’s score of 900 may still have a serious observation in one of the five categories of the standard. Not unlike a performance review, a lower number in one category, balanced off with good performance in the other four categories, does not mean that improvements are not needed. The report should be taken as a total document, not just a score.
Superior/Excellent RatingsThese terms have been part of the AIB Consolidated Standards for 50 years and were designed as recognition of achievement for management and plant personnel to encourage them to keep improving their GMP compliance program. In most facilities, this has been useful for year-to-year improvement and reduction of food safety failure risk.
AIB encourages that companies do not use the score alone as part of the review of a potential supplier. The comments and observations provided by the report should be used in its entirety for the best indication of the plant’s food safety program. Also, corrective action confirmation may be necessary to complete a supplier approval process.
Announced/Unannounced AuditsAIB International supports the use of both announced and unannounced audits as an important component of ensuring the food supply of the U.S. food system.
Announced audits provide the best opportunity to train onsite personnel to validate the effectiveness of onsite self-inspection and to transfer the best practices from one firm to another.
Unannounced audits provide the best day-to-day view of the operations. They provide the best insight for companies purchasing products from a facility and should be used in conjunction with other requirements (certificate of analysis, independent lab analysis and purchasing protocol, history, etc.), to lower the risk of a food safety failure.
Most AIB GMP inspections are once per year in a 1- to 2-day visit. Most companies take the inspection as an opportunity to truly assess how they stack up against the standard and prior inspections.
Audit Company/Client RelationshipAudits are paid for by facility/company having the service provided, not unlike financial audits would be self-paid. This has been a standard practice for more than 50 years.
There is no incentive pay for audit results or customer location in AIB’s case. AIB auditors are full-time employees.
Auditor contact occurs when scheduling announced audits with facility personnel to assure that proper personnel are available. AIB’s current policy is that auditors are rotated out after three consecutive visits.
For more information, visit www.aibonline.org.