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45 STATES

Case Studies

Opening New Opportunities for a Processing Plant

Keeping Key
Business With a
New Certification

A Last-Minute
Deadline to Keep the Doors Open

Creating a New
HAACP Program to Go Wholesale

CASE STUDY 1

Opening New Opportunities for a Processing Plant

A nut processor in the western US wanted to become SQF certified to meet customer requirements and open new market opportunities.

The Overview:

  • Operational complexity around the use of co-packers to address food safety concerns.
  • Required a unique supply chain program and flow chart to address steps taking place in four separate physical locations.
  • They also import and package products for their customers.

The Result:

Proper management oversight of the program and successfully gaining SQF Certification.

Our Process

Food Safety Gap Assessment

  • The processing plant had existing documentation for standard operating procedures but was concerned it was incomplete. They had never undergone a third-party audit and they wanted help updating their documents to meet both FDA FSMA requirements and SQF standards.

Program Development

  • We helped them understand how much resources and time needed to be allocated in order to assure success internally. Our in-depth Scheduled Action Item List and Implementation Schedule detailed each required policy, procedure, and implementation step.
  • A preliminary document set of policies, procedures, and forms were created by our team in four weeks based on existing client standard operating procedures, identifying responsibilities, and basic processes to meet SQF requirements.
  • The SQF program documentation created was larger than expected for the nut processing plant. We worked with them to understand the purpose of the documentation in order to comply with all requirements for the SQF Program.
  • Based on our recommendations, they decided to hire a full-time Quality Assurance Specialist to help with the implementation of the program.

Implementation

  • The Quality Assurance Specialist and Kellerman Consulting conducted weekly implementation meetings to facilitate the implementation of each policy, procedure, and program section by section, over the course of 9 weeks.
  • Updates and changes were made to programs as needed to better fine-tune documentation to the facility.

Audit and Inspection Preparation

  • We conducted a full-day on-site visit to assist with final implementation prior to the SQF desk audit.
  • Prior to the desk audit, the auditor sent incorrect information about the scope and expected audit schedule. This happens more often than not. We helped the plant to correct the scope issues and prepare for the correct audit schedule, even though it was not communicated accurately by the auditor.

Audit and Inspection Virtual Support

  • Desk Audit:
    • During the desk audit, the auditor confirmed that the audit schedule was incorrect, and performed the desk audit in accordance with our suggestions.
    • After the desk audit, we found several incorrect findings made by the auditor that required unnecessary corrective actions. We advised on how to resolve the erroneous findings in order to avoid conflict with the auditor as well as to pass the desk audit as well as after completion of audit.
  • In-Person Training
    • We did in-person training and on-site corrective action planning based on the auditor’s finding, which included educating the client on the auditor’s misinterpretation of the code. All corrective actions were accepted.
  • Auditor Relations Support
    • We educated the client on problematic behavior displayed by the auditor leading up to the audit as well as during the desk audit, and the client was then able to identify continued instances of inappropriate auditor behavior during the site audit that contradicted the SQF code.
    • We showed how to comply with auditor expectations and how to adjust the program for the annual recertification audit where a new auditor would be requested.
    • Following the site audit, Kellerman Consulting advised the client on multiple findings that were appealed and overturned on review.

The nut processing plant got a passing grade on the SQF audit that assured 12-month recertification.
Facing a similar challenge? Click the button below to get in touch.

CASE STUDY 2

Keeping Key Business with a New Certification

A family-owned produce storage and distribution company wanted to convert their BRC program to an SQF program for two reasons: it was no longer a good fit for their type of business and their main customers wanted them to have an SQF certification.

The Overview:

  • They risked losing their business if they could not maintain their GFSI certification.
  • The company had been BRC certified for multiple years, but the certification was at risk of withdrawal following a series of audits.
  • They need help assessing their existing BRC documentation and to convert the program to SQF.

The Result:

Proactive actions to assure proper auditing and successfully gaining SQF certification.

Our Process

Food Safety Gap Assessment

  • We found that the BRC documents that may have once existed to address BRC programs, policies, procedures and risk assessments were not available for review. Regardless of the reason, only a small number of audit forms were on hand, along with written statements detailing audit inspection processes.
  • A new program was required to be developed in order to meet SQF requirements.
  • The use of a new ERP system to manage product inventory was also identified. None of the previous audit inspections addressed the use of an ERP system, therefore the SQF program needed to incorporate the use of the new ERP system.

Program Development

  • We wrote a full suite of SQF documents written for the identified SQF modules (Systems Elements and Module 12 Storage & Distribution), which included 125 documents totaling over 300 pages and incorporated the functionality of the new ERP system.
  • Program documentation addressed specific storage and distribution language and program requirements that assured program conformance during desk and site audit.
  • The documentation we created addressed their operational realities (including deliveries and inventory corrections) and assured that customer interactions were conducted in compliance with SQF requirements.

Implementation

  • We reviewed each document set, the ERP system and how it functioned within operations, and identification of key personnel to perform each function required to administer the SQF Program with the company.
  • With the Senior Site Manager and SQF practitioner, we conducted virtual implementation support. We made sure all critical personnel understood the SQF program, what to expect during the desk and site audit, and how improvements could be made to their operation to effectively meet SQF requirements.
  • We addressed questions on how to properly use recordkeeping forms to validate and verify all required SQF program actions.

Audit and Inspection Preparation

  • Training and coaching was provided to address what to expect during the audit.
  • The flow chart and hazard analysis were fine-tuned in order to address repackaging activities involving a small amount of inventory.
  • We advised the client that current sanitation and operational programs were at or above SQF standards and did not require significant adjustments.
  • Recordkeeping forms and standard operating procedures were customized to assure that existing practices were not changed.

Audit and Inspection Virtual Support

  • Real-time virtual support was provided during both the desk audit and site audit. We addressed all desk audit non-conformance findings within the allotted time frame between desk audit and site audit. Several findings were in dispute due to the auditor’s failure to fully examine documentation during the desk audit which we were able to help resolve.
  • During the desk audit review, the certifying body terminated the employment of the auditor and reversed the auditor’s findings to match the conclusions made by our team. A new auditor was then assigned for the site audit.

The facility got a passing grade on the SQF audit allowing for a 12-month recertification.
Facing a similar challenge? Click the button below to get in touch.

CASE STUDY 3

A Last-Minute Deadline to Keep the Doors Open

A produce importing company needed to quickly complete the FDA’s Foreign Supplier Verification Program in order to continue day-to-day business. They had a 14-day deadline.

The Overview:

  • Frequently, smaller importers are unaware of the requirements for a foreign supplier verification program.
  • The FDA informed the company they had 14 days to submit a completed FSVP and supplier risk assessments.
  • They had two major concerns: (1) Food items they intended to import may be detained, confiscated, and possibly destroyed, and (2) they weren’t in a position to quickly develop documentation for testing and hazard analysis if needed.

The Result:

From our experience writing many Foreign Supplier Verification Programs, we helped the firm meet the 14-day deadline. The FDA approved the program and allowed them to continue operating without any disruption to their business.

Our Process

Food Safety Gap Assessment

  • Special attention was paid to providing concrete proof that the food safety documentation provided would alleviate the need for food testing or other onerous ongoing activities.
  • An issue that arose was that no employees had undergone FSVP training and foreign supplier risk assessments had not been performed.
  • We considered the inherent safety of the food items imported, we reviewed the food safety documentation provided by each foreign supplier as well as the intended use of each food item in order to assess whether additional food safety actions were required for the firm.

Program Development

  • We wrote and provided all Foreign Supplier Verification Program documents including policies, procedures, roles and responsibilities, validation, and verification actions in order to assure that the firm met all FDA FSVP requirements.
  • We found that the firm did not require testing or other food safety actions for the food items once they entered the US.
  • Program documentation addressed an overview of the food items, suppliers, and logistical nature of importation as it pertained to food safety.
  • It also included monitoring forms and supplier assessments required by the FDA to meet minimum food safety requirements

Implementation

  • full supplier food safety document review and assistance completing risk assessment forms prior to submission to the FDA was done.
  • All documentation and implementation assistance was completed within the 14-day window, and we provided guidance each step of the way for the firm to understand how to organize the documentation to meet ongoing requirements, not just fix the immediate problem.
  • We stayed with the project and communicated before, during, and after FDA inspection to make sure the project was a success.

The firm is now in a position to continue operation and expand to new suppliers without fear of regulatory infractions or business disruption.
Facing a similar challenge? Click the button below to get in touch.

CASE STUDY 4

Creating a New HACCP Program to Go Wholesale

A regional grocery store chain with a central commissary facility for their grocery chains wanted to make improvements to their food safety program in order to start selling wholesale.

The Overview:

  • They were exempt from having to comply with FDA and USDA wholesale manufacturing requirements because they packaged food for sale in their own retail grocery store locations.
  • Food safety plans were required for all items if the company wanted to sell to other businesses.
  • Redesign of operations had been performed by a high-level employee with a manufacturing background, but the documentation sets reflected a mix of retail and wholesale concepts that were out of line with their current practices.
  • Operational procedures, policies, and practices become set based on the retail rules, which doesn’t adequately prepare the commissary for the realities of wholesale manufacturing.

The Result:

8 food safety plans (including HACCP and Preventive Controls) were created along with on-site training. All inspections were passed.

Our Process

Food Safety Gap Assessment

  • They had a large list of food items but no food safety plans in place, as they were exempt. They needed the development of complex flow charts and SOPs.
  • The commissary documents had been organized by multiple employees from differing operational backgrounds. As a result, the formatting of their food safety documents were inconsistent and responsibilities were not clear.
  • Metal detection was performed, but validation and verification practices were based on faulty notions of what each process entailed, resulting in incomplete documentation.
  • The documented Sanitation Standard Operating Procedures, Recall Plan, foreign materials controls and GMPs did not reflect current facility practices.

Program Development

  • 8 separate food safety plans (both HACCP and Preventive Controls plans) were created, each customized to operational requirements to meet all potential federal regulatory (FDA and FSIS) requirements.
  • All food safety plans were reviewed and accepted by the commissary.
  • Critical Control points, preventive controls for allergens, sanitation, supply chain control, and recall plans were added.
  • GMP documents based on existing policies and procedures were updated to improve formatting with more clear statements on roles, responsibilities, validation, verification and corrective actions.

Implementation

  • We worked with the Quality Assurance Manager and senior management to make sure that implementation was completed correctly by the commissary.
  • We provided support once the program was submitted to the client and was able to answer questions about how to best update the program and practices in the facility related to food safety.
  • Our team worked with the QA Manager to remotely adjust the food safety plans as needed.

Training

  • The commissary felt more secure in their operations with written policies and procedures that accurately reflected current manufacturing practices.
  • During the onsite training, our team met with personnel from operations, quality, and management and was able to help the commissary better understand how food safety plans were developed as well as what types of considerations were most important for their system.

The commissary felt more secure in moving towards wholesale operations.
The program moved them much closer to not only federal regulatory compliance but also in being ready to handle the development and implementation of GFSI Certification down the road.
Facing a similar challenge? Click the button below to get in touch.

Speak With Us to Help Resolve Your Food Safety Certification and Compliance Needs

Since 2017, we’ve assisted 500+ clients throughout the food supply chain and we’ve seen it all.

From SQF to BRC to FSSC 22000 to GMP and more, we write your program, train you, help with implementation, and stay with you until you pass your audit.

Responsive, straightforward, and dedicated to our clients, our success rate is 100% because we stay with our clients until they pass, no matter what. 

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