Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jón Bergsteinsson
Understanding the standard is essential
Stephanie Ojeda
The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Steve Thompson
An excellent technological tool that improves quality and compliance
Kelley Jacobsen
Amid rising prices, medical device supply chains need greater scrutiny and standardization
Jennifer Chu
Findings point to faster way to find bacteria in food, water, and clinical samples

More Features

FDA Compliance News
Streamlines annual regulatory review for life sciences
Facilitates quick sanitary compliance and production changeover
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity

More News

Brandon Henning

FDA Compliance

Will You Be Ready for a FSMA Audit?

Four tips to pass an FDA audit

Published: Tuesday, February 2, 2016 - 13:46

Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017.

Will you be ready for your audit when the FDA comes knocking? Here are some simple steps you can take to help ensure you can pass your audit with flying colors.

1. Have a FSMA-qualified quality manager oversee your internal compliance. This is the person who will lead all of your internal compliance initiatives, including but not limited to:
• Ensuring that you have a FSMA-trained quality associate at every facility
• Verifying that your hazard analysis and risk-based preventive controls meet the requirements of FSMA Section 103 and corresponding rules of the FSMA regulation
• Leading the effort of getting all your internal quality documents organized, and ensuring all manufacturing facilities are using the correct, approved version of all documents that affect quality. This will ensure that you comply with FSMA Section 101—Inspection of records

2. Have a FSMA-qualified supplier quality manager in place. One of the biggest changes FSMA is driving is how manufacturers work with suppliers and importers. Manufacturers and processors will now be held much more accountable for food safety and risk introduced into the food supply chain. Your existing quality assurance staff is already overburdened and won’t be able to drive the programs required to ensure you are meeting the regulations when the FDA comes to audit you. A supplier quality manager can work closely with the FSMA-qualified internal quality manager and will lead all of the supplier-compliance initiatives, including but not limited to:
• Putting systems in place that identify the suppliers from which you buy or import ingredients and materials, the supplier/importer sites from which those ingredients come (i.e., your supplier’s supplier), and which manufacturing sites are approved to receive ingredients from the supplier or importer sites with which you are contracting. This will ensure you comply with Section 103—Hazard and risk-based preventive controls as it relates to a manufacturer’s culpability for suppliers, which is new with FSMA. In addition, this supports compliance for FSMA Section 301—Foreign supplier verification program.
• Leading the effort to ensure that all the supplier documents required by the FDA are provided and organized. This includes both compliance and certification documents that are updated and collected on a scheduled frequency, such as GMP and HACCP plans, non-GMO certification, and MSDS, as well as transactional documents that come in with every shipment, such as COA and lab or test results, ensuring compliance with FSMA Section 101—Inspection of records.
• Ensuring that each supplier site or importer site has an up-to-date risk assessment. This person will also ensure that additional risk assessments and any required site audits are performed, based on the supplier site or importer risk score and frequency defined in your food safety plan. This supports compliance not only with Section 103 as is it relates to a manufacturer’s culpability to suppliers, but also with Section 301.
• Leading the supplier site or importer site audits, supporting Sections 103 and 301, related to supplier management and foreign supplier verification.

3. Implement an automated quality management system (QMS). With the increased focus on food safety from the FDA, the manual and disparate word documents and spreadsheets used to collect quality data, and the disorganized systems used to manage quality documentation will no longer suffice. With an automated QMS, you can quickly and efficiently show to the FDA:
• Your quality documents (e.g., SOPs),
• Which sites you have audited
• Where there are incidents that could have an effect on food safety
• What corrective actions are being taken to ensure the incidents are followed up and corrected as required
• Compliance support for FSMA Sections 101—Inspection of records, 102—Registration of food facilities, 103—Hazard analysis and risk-based preventive controls, 106—Protection against intentional adulteration, and 204—Enhancing tracking and tracing of food record keeping.

When searching for a quality management system, look for one that has the following capabilities.
• Full set of integrated quality modules, including document control, quality incident tracking and complaints, audits, corrective actions and training (especially since you now have to prove to the FDA that all quality employees are trained on the latest SOPs)
• Workflow tool to ensure that all of the tasks necessary for you to comply with your quality SOPs and food safety programs are executed, with the ability to notify and escalate if the tasks are not executed per the plan.
• Quality analytics and mobile data collection capabilities, to effectively measure and capture quality management data.

4. Implement a supplier QMS. As stated before, the place where food manufacturers tend to be the weakest in terms of FSMA compliance is in the area of supplier and importer quality management. The systems used to support quality (e.g., manual systems, ERP, EH&S, PLM, and MES) are not designed to support compliance with FSMA’s Supplier and Foreign Supplier Verification Programs. As an example, FSMA requires that manufacturers not only have a record of which brokers and suppliers they pay, but also the supplier and importer sites where ingredients (especially high-risk ingredients) come. Unfortunately, the systems in place to manage the relationship with suppliers (e.g., ERP, purchasing, and PLM) were never designed to provide the level of detail required to support FSMA compliance. By putting a supply quality management system in place, food and beverage manufacturers will be in a much better position to comply with FSMA Sections 1—Inspection of records), 103—Hazard analysis and risk-based preventive controls, 106—Prevention against intentional adulteration, 111—Sanitary transportation of food), 301—Foreign supplier verification program, and 304—Prior notice of imported food shipments.

When looking for a supplier QMS, look for the following system capabilities:
• Global supplier catalog with the ability to track all the way down to the supplier/importer site level, as well as the relationship between which ingredients come from which supplier/importer sites, and which in turn are approved for which manufacturing sites
• Supplier risk-scoring and execution of supplier risk assessments
• Supplier auditing, both internal and via third-party auditors (online and off-line audits)
• Supplier corrective action
• Supplier portal that facilitates the communication of audits, audit findings, corrective actions, as well BOM and specification change communication
• Supplier analytics and mobile capability

The software vendor should also have a good grasp of FSMA and a methodology to implement supplier quality in phases, so as not to overwhelm the quality organization and executives with new procedures and requirements.

If you follow the steps above, not only will you pass your FDA audit, but you might also become the FDA “poster child” for how to execute a quality program that truly ensures food safety across the supply chain.


About The Author

Brandon Henning’s picture

Brandon Henning

Brandon Henning has been involved in food and beverage and consumer goods manufacturing for more than 20 years. He spent more than a decade at The J.M. Smucker Co. managing IT teams that affected operations, manufacturing, quality, HR, and maintenance. He also worked for GE Intelligent Platforms and Rockwell Automation where he focused on delivering quality and manufacturing systems to food and beverage and consumer goods manufacturing companies. Recently, Henning joined Sparta Systems to lead the consumer goods industry vertical, as the director of industry solutions.