Tag Archives: audit prep

Nicole Keresztes James

Five Tips to Prepare for Your Next Audit

By Nicole Keresztes James
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Nicole Keresztes James

For food manufacturers, passing a third-party food safety and quality audit supports both business growth and the ability to obtain new customers. Many retailers have made certification to a GFSI-benchmarked standard a minimum requirement of their suppliers. Working towards compliance with a third-party audit, let alone a GFSI-benchmarked certification, is a journey that requires significant preparation. Understanding the typical mistakes companies make on this journey, and taking action to avoid them can go a long way in properly preparing for and successfully passing the audit. Here are five essential tips to help businesses prepare for a food safety audit.

1. Start Early

Procrastination is on one of the most common causes of an audit failure. Starting the preparation process too late can cause significant challenges. The first step in preparing for an audit should be to set a timeline well in advance, identifying key checkpoints and milestones to ensure activities meet compliance.

If you have the option, choose an audit standard that fits with the facility and meets the end goal. Some questions to ask in your selection process include:

  • Is the certification to a GFSI-benchmarked standard required?
  • Is a completed third-party food safety and quality audit sufficient?
  • Is a customer-specific audit needed?

Once you’ve decided on the audit standard, select a third-party certification body or audit firm to deliver an audit to the standard’s requirements. Ensuring that the certification body or audit firm you choose is qualified to conduct the audit (e.g., accredited or approved by the standard) is crucial.

Next, secure a copy of the selected standard. With GFSI-aligned programs (including GFSI and non-GFSI benchmarked standards), standard expectations are available freely and directly from the certification program owners. In the case of proprietary third-party audit and customer standards, the chosen certification body or audit firm can assist with providing the necessary expectations.

2. Get Up to Speed

It is extremely important to thoroughly review and familiarize yourself with the standard or expectations manual, especially if the standard or manual is new to the facility. If the audit is a reassessment, ensure you have the most recent version of the standard or manual and thoroughly read it, as updates may have been made since the last audit.

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One mistake we sometimes see is failing to designate an internal core team for the audit. Doing so can help ensure the timeline is followed and critical tasks are assigned accordingly. If you are doing a reassessment, ensure that all internal organizational changes have been documented and that organization charts and rosters have been updated.

For reassessments, it’s also important to revisit any nonconformances from previous audits and the reports of any other assessments or internal audits completed. Doing so ahead of time can confirm that corrective actions have been fully implemented and preventive actions put in place, minimizing the recurrence of nonconformances.

3.Complete a Self-Assessment

Conduct an internal audit using the audit standard or expectations manual to identify compliance gaps. Address any deficiencies through corrective actions, focusing on areas such as sanitation and cleanliness, facility condition, pest management programs and maintenance protocols. Looking at each of these areas, identify and address opportunities for improvement. Issues in these areas are very often cited as nonconformances during audits.

Before the audit, meet with your third-party service providers to ensure programs are up to date and that there is awareness of any issues. Even when programs, such as pest control, are outsourced to third-party organizations, the facility remains responsible for overseeing such programs.

4. Prepare Documentation and Ensure Implementation

Documentation is critical for audit success. Ensure a comprehensive review of your food safety systems (e.g., HACCP and FSMA PC) to ensure that they are current and valid. Review the efficiency of your process implementation and verify that the documentation and processes are aligned.

Training is a must-have for audit compliance; therefore, confirm that internal training has occurred and been documented. This includes training not just for the team escorting the auditor during the audit but for all employees, as during the visit employees in functions key to the audit’s scope may be called on by the auditor to answer questions. Remember, well-trained employees are confident in conducting and describing their processes and how they connect to food safety and quality. They must also follow the procedures as stated in the documented programs and policies.

5. Collaborate and Ask for Help

Failures occur when assumptions are made. Many audits are unsuccessful because facility management and employees assume they understand and have implemented the necessary requirements.

When in doubt, ask for help. As stated above, preparing for any audit is a significant undertaking. Expert resources can help with that preparation and assist with avoiding gaps and the rework that occurs when expectations are not clearly understood. Check with the certification body or audit firm that has scheduled the audit—many will offer separate consulting and training services to help with audit preparation.

It is important to note that one facility is just one point in the overall supply chain and that stakeholders include both suppliers and customers of the facility. These suppliers and customers can play a role in the success of an audit. Ensure that communication with all involved parties is part of the preparation.

Keep the Momentum Going

Once you complete an audit, celebrate and congratulate the team. At the same time, remember that the work doesn’t end once the audit is complete. Even after completing the corrective actions, you should start preparing for the next audit by keeping documents and records updated. Adequate food safety and quality assurance are only possible when activities connected to these concepts are carried out every day. Keeping compliance top-of-mind daily has the additional significant benefit of always being audit-ready.

As the adage says, “Fail to plan, plan to fail.” This certainly rings true with audit readiness. However, it is key to remember that an audit is merely a data point on the spectrum of a robust food safety and quality system that is constantly evolving and improving. This comprehensive system does not come about just because there is an audit to plan for. It is a product of daily work to ensure that procedures and policies are being followed and a cross-functional team that is striving to make a facility’s food safety culture stronger and ever more capable of preventing food safety and quality incidents.

Bob Savage, President and Founder of the HACCP Consulting Group

FSQA: Creating HACCP Excellence

By Michael Biros
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Bob Savage, President and Founder of the HACCP Consulting Group

For a successful Food Safety and Quality Assurance program, there must be management commitment and measurable expectations set. Senior management has to be committed to the program. They are the foundation for everything in food safety. They have to provide resources to develop and implement the plans across different departments as well as provide for training and encourage communication, advises Robert A. Savage, President and Founder of The HACCP Consulting Group.

Sharing some lessons learned from decades of HACCP implementation experience, Savage spoke at a recent webinar on FSQA: Creating HACCP Excellence, presented by SafetyChain Software. We present excerpts below. 

A few years ago, there was a very serious Salmonella outbreak in peanut butter. It appears that company shopped around for negative salmonella results and then shipped the product. It’s a worst case scenario, but in this case, short term profitability at the expense of food safety resulted in the over 600 illnesses and a few deaths as well as the bankruptcy of the company, described Savage.

Role of GMPs in Creating and Minimizing CCPs

Without good GMPs, facilities tend to have more CCPs than necessary. There has to be a good balance between GMPs and CCPs. When companies understand the the relationship between HACCP, GMPs, and CCPs, typically the HACCP plan would not have more than 3 or 4 CCPs and everything else is covered by GMPs. 

Best practices for HACCP management must be committed from the beginning and throughout the process. GMPs should be in place prior to even beginning to revamp the HACCP plan. Multidisciplinary HACCP teams, including QC, QA, Lab, Sanitation, Product Development and Sales, experts, should contribute to the process in developing the plan. Having a multidisciplinary team helps with achieving buy-in or company-wide commitment to the plan. 

Companies have been pretty good with monitoring, but there’s still some confusion between verification and validation. Verification is a check of the checkers. When CCPs are identified and monitored, verification is making sure that the company says what it’s doing and is doing what it says. Validation asks if the company has the right CCPs and how can they prove it. 

Best Practices for Audit Prep

USDA regulated plants have routine inspections to verify what the companies do on an everyday basis. Separate from these routine inspections, USDA also performs food safety assessments which can take days or weeks to complete. Companies under USDA jurisdiction should do their own food safety inspection to prepare for these FSIS audits. FDA regulated plants may go months or years between inspections. These facilities should have third party audits such as SQF or other audits. 

GFSI schemes have taken hold in the US and around the world. The popular one in the U.S. is SQF. Companies that meet SQF standards should have no problem meeting new FDA FSMA regulations.