Everything you should know about audits conducted for food and packaging safety, but were either afraid to ask or you simply didn’t know what you didn’t know is presented with step-by-step clarity by food safety expert Gary Kestenbaum.
In Part 1 of this series posted last week, A clearer path to food safety compliance, food safety expert Kestenbaum explored common food safety program and preparedness analysis technique. In this article, he discusses basic objectives, protocols, similarities and differences.
Audit protocols may vary depending upon a variety of factors. The following are general descriptions of typical audit types occurring within the food and packaging industries.
Primary or “1st party” audits
Primary or first party internal audits are typically informal walkabouts, evaluations and observations executed by members of a facility internal safety or performance team. Team members inspect and assess food safety performance in production facilities or satellite locations against written corporate standards and procedures. The inspection concludes with a written summary of observations and required improvements linked to action items. Team representatives meet with Operations staff to discuss results and next steps.
Secondary or “2nd party” audits
Stakeholders use internal or external expert resources to formally audit (inspect and qualitatively grade) individual facilities (manufacturing, warehousing etc.) where food products and packaging components are converted, manufactured, stored and shipped. The criteria for inspection are typically composed of written, internal documents containing food safety requirements, procedures and expectations.
2nd party audits are semi-formal, but may be more challenging to the facility that 3rd party audits, particularly when the auditor is a Company expert having deep knowledge of the facility, operations and business objectives. This type of audit is performed with guidance and cross-conversations during the inspection. The inspection concludes with a summary of expectations, observations and conclusions, including a written list of non-conformances, omissions and needs for corrections, improvement and next steps, often including timing for re-inspection or remedial assistance.
Third Party Audits
Third-party food and packaging safety audits are performed for a variety of reasons, but for the purpose of this discussion, I will refer to a scored audit requested by a partner or member in a chain of supply with the specific intent to verify a vendor or supplier compliance with a specific food safety program. Again, typically, the audit criteria for success (performance requirements and expectations) are developed using current, written food safety standards influenced by industry best practices and related regulations.
Audits are usually most effective when performed by certified auditors with training or experience in the categories (food ingredients, food processing, packaging ingredient or components conversion, etc.) they audit. The auditor’s objective is to assess and evaluate the ability of the audited facility and overall organization to insure intake, handling, production and distribution of safe food and packaging to and through the supply chain and ultimately to consumers. The audit is intended to determine if appropriate industry-accepted written food safety program procedures are in place and, if so, that management and staff are applying those written procedures effectively and consistently in order to produce safe products. In other words, the auditor is looking for evidence that auditee’s written procedures and protocols are in place, being performed and properly documented. Auditees should expect trace, recall, non-conforming product or defect logs and related actions or follow ups to undergo auditor scrutiny for evidence of effectiveness and validation.
Auditees should be presented with or obtain, in advance, a written manual containing all program stipulations and expectations. Reference guides for most major food packaging safety programs, or “schemes”, as they are often referred, are available from either the organization itself or from third parties. These guides provide clarification, examples and general assistance to those unfamiliar with the specifics within the program or scheme.
Most branded programs and schemes connected to the quality and safety industry leaders are developed using a broad array of information including, but not limited to:
- Latest global food and packaging material and component safety standards;
- Legal guidance and requirements;
- Documented best practices and processes;
- Observed safety risks identified by global experts and regulators; and
- Relevant data and related information from scientific-based global organizations.
Some auditors will have deep familiarity with the industry they are auditing; others may have general familiarity with manufacturing, handling and storage facilities in general, but not specific, hand-on experience with the specific equipment, processes and methodologies used at your facility. Therefore, deeply experienced auditors may ask very specific questions about process safety. Others may ask the auditee representative to provide evidence as proof that policies, procedures and related, reasonable mitigations are in place and functioning, as written, against each connected requirement in the expectations manual.
Audits, depending upon the degree of difficulty and scope, are often bifurcated. Step 1 in the process is evaluation of the general organization, purpose and objectives, documents and related processes. Step 2 involves inspections of the building(s), processes, infrastructure, site and grounds.
Typical audits are both qualitative and quantitative (scored). The scoring process will be explained to the auditee and, often, the auditor will give the auditee a qualitative summary of deficiencies.
The qualitative component of a 3rd party audit is intended to function as:
- Auditor’s expert and independent interpretation of the auditee’s understanding, execution and process effectiveness against each individual written requirements or expectations included in the specified, target food safety program or scheme.
The quantitative component of a third party audit is intended to:
- Alphanumerically grade the execution, quality, performance, compliance, functionality and effectiveness of each aforementioned requirement or stipulation included in the specified, target food safety program or scheme.
- Add or subtract points or grades from targeted totals within the process based on auditor’s observations of data and execution, as well as auditee explanations and evidence.
Results for both components are determined based on the concept “if there is no visual, written or credible evidence or proof that the requirement or stipulation exists and is being performed, it didn’t happen or doesn’t exist.”
In other words, it is reasonable and expected for readers of an audit summary to easily conclude whether or not the auditee documents, maintains and effectively executes each requirement or expectation within the targeted food or packaging safety program and that adequate records and evidence exists to sustain proof of same.
Auditer and auditee details
Auditors may be counseled to limit the detail they provide to the auditee upon completion of the visit and discouraged from providing auditees with lengthy explanations on scoring rationale at the completion of the audit. The audit process is most likely to conclude fairly and accurately when all steps are completed. An auditor needs time and opportunity to review notes, consider all factors and then write an accurate report, which is submitted to a supervisor and reviewed again for accuracy, fairness and completeness. Typically, the auditing firm sends a copy of the report to the auditee and will reasonably consider comments from same relating to disagreements, discrepancies, omissions or misinterpretations. Auditing companies attempt to be fair and reasonable, but at times the auditor and the auditee may “agree to disagree” on performance against expectations.
To summarize, auditors are attempting to verify that the auditee:
- Facility management understands the precepts and policies required by the targeted food safety program as described in the expectation manual;
- Has created and implemented procedures to address, control and mitigate risks connected to general food and packaging safety;
- Has documented and proven the use and effectiveness of those procedures;
- Has documented or proven employee performance and understanding of any and all procedures.
Whether manufacturing or conversion takes place in a clean environment (injection stretch blow molding, for example) or in a sensorially displeasing environment (paper recycling and manufacturing, for example), the ultimate expectations are similar: demonstrate that raw materials, intermediates and finished products are being converted or manufactured in a controlled facility, using applicable, effective food safety process controls, that the general grounds and environment are free from contamination and vermin and that all mandated processes and controls required by law (and recognized industry guidance) are understood, practiced and documented.
Auditees should be able to demonstrate to an auditor how the processes in place protect all goods destined for consumer use are so that they are controlled and free from physical, chemical and biological hazards and contamination.
In the rare event that a major food safety breach is observed during the audit or that practices at the facility represent a clear and present danger to consumer and customers, the auditor may suspend the audit and report a summary of same to his supervisors and to the designated representative at the facility under inspection. In the event evidence demonstrates that auditee documentation or understanding is consistently insufficient or absent, auditor may logically propose suspension of the audit to a later date after auditee has been given time to comply.
I personally witnessed an audit wherein the auditee was downgraded for not maintaining written records demonstrating employee understanding of food safety protocols. The production supervisor argued that it was culturally offensive to employees to force them to take written safety comprehension tests in order to demonstrate use. Finally, the parties agreed that in this case, proof of employee comprehension and performance would be considered effective following oral discussion between employee and supervisor, followed by demonstrated execution of food safety procedures, summarized and documented in writing by the supervisor and placed in a file for auditor’s review. The takeaway is that professional auditors are trained and encouraged to dialogue with the auditee, giving them ample opportunity to explain how what they are doing does in fact comply with the spirit and intent of food and packaging safety program requirements.
The 3rd and final part of this series concludes with Guidance for food and packaging safety inspection and evaluation.
Gary Kestenbaum has 40 years’ experience in the food and packaging industries, six as a supplier with National Starch, 18 as a product developer with General/Kraft Foods and 15 as a packaging engineer and developer with Kraft. As senior food packaging safety consultant with EHA Consulting Group, Kestenbaum provides guidance on packaging safety and suitability-related projects for raw material manufacturers, converters and associated supporting professionals. He can be reached at [email protected] or 410-484-9133. The website is www.ehagroup.com.