Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 observations. In fact, documentation is cited in virtually every one of the dozens of warning letters issued to food and beverage companies in 2022. Inspection observations from the infant formula crisis reveal issues with standard operating procedures (SOPs). In that case, inadequate documentation had a far-reaching impact.
Where are food manufacturers going wrong, and what can they do to avoid future documentation citations?
In this article, we identify five documentation mistakes to address, and how companies can use the quality management system (QMS) to eliminate gaps and compliance risks.
Foreign Supplier Verification Program
The Food Safety Modernization Act (FSMA) requires food companies to develop and maintain a Foreign Supplier Verification Program (FSVP) for imported foods. FSVP violations account for nearly half of the warning letters in 2022.
Perhaps not surprisingly, documentation is a common theme among these warning letters. Violations cover issues such as:
- Not having an FSVP to begin with, including for small importers
- Not documenting and reviewing their assessment of a foreign supplier’s hazard analysis, which must be performed by a qualified individual and is required for each imported food to identify hazards requiring a control
- Creating and following written procedures around foreign supplier approval processes, which must be based on food risk and the supplier’s past performance
- Establishing and documenting foreign supplier verification protocols
QMS perspective: An automated QMS helps avoid documentation issues that relate to FSVP by making it simple to create auditable documentation of the FSVP, including:
- Review and assessment of any foreign supplier’s hazard analysis
- Documentation of qualifications for the qualified individual completing the assessment
- Written procedures for approval processes
- Verification protocols and monitoring records
Corrective Action Documentation
Next to FSVP violations, corrective action was one of the most frequently cited problems in recent warning letters to food manufacturers. Specific violations include:
- Not documenting corrective action activities in response to inspection findings or 483 observation letters
- Lack of corrective action procedures describing steps needed to prevent adulteration of food
- Not providing supporting documentation showing corrective actions, and if they are effective
- Lack of documentation around root cause analysis completed to demonstrate that the true cause of a problem has been identified, including problems leading to recalls
QMS perspective: Corrective actions need to be completed almost immediately to be able to submit documentation of corrections within 15 days of receiving a warning letter, making corrective action tracking critical. Within the QMS, manufacturers should link employee training with corrective action tracking and change control. In addition, a QMS leverages root cause analysis tools such as 8D problem-solving to document investigation activities.
Employee Training Records
Under 21 CFR 117.4, food manufacturers must maintain documentation of training for all employees involved in food manufacturing, processing, packing,and holding. However, lack of employee training records remains a top violation cited in FDA warning letters. In at least one case, a manufacturer was cited for not providing supporting documentation of training employees on new procedures in response to an FDA inspection.
QMS perspective: Employee training must link to corrective action and document management in the QMS. The system can trigger new training requirements based on corrective actions or updates to written procedures, with action items and alerts to stay on track. This is essential to creating a closed-loop process that ensures complete documentation of FDA compliance.
Process Monitoring and Calibration Records
Recent FDA enforcement activities show how a lack of procedures for process monitoring and calibration drive up compliance risks. Issues cited here include a lack of documentation around how preventive controls are monitored and calibration of process monitoring and verification equipment.
QMS perspective: An automated QMS allows manufacturers to track gaps in process documentation, also allowing them to maintain monitoring and calibration records to demonstrate ongoing compliance. Key capabilities to integrate here include document management, quality records, and calibration activities. Calibration management in the QMS is key to tracking required calibration frequencies, identifying critical to quality (CTQ) devices, and attaching certificates of calibration to device records.
Written Sanitation Procedures
FDA warning letters cite multiple instances of food manufacturers not developing, maintaining, or following written sanitation procedures correctly. Violations in this category focus on issues such as:
- Not having written procedures specific to the facility or food product
- Incomplete documentation, for instance leaving out procedures for specific equipment and not specifying the soap, tools, or techniques to use
- Not providing complete sanitation monitoring records to demonstrate implementation of procedures, including revisions in response to FDA enforcement
- Poor record keeping, such as when sanitation control records are completed after the shift rather than documenting actual conditions
QMS perspective: Storing and maintaining documents in the QMS is a key advantage to FDA compliance. It allows manufacturers to see where they need to create documents, schedule and track reviews, and link document updates to FDA compliance findings. Companies can link sanitation procedures with monitoring action items, ensuring alignment between documented processes and plant floor checks.
A digital QMS can also attach photos and videos as objective evidence supporting sanitation compliance. Furthermore, it creates a historical digital database for employee review and training.
Incomplete or inadequate documentation is a persistent problem for food manufacturers, as evidenced by recent FDA enforcement activities. Documentation is the foundation of an effective food safety QMS, but it’s not enough to create process documents that comply with FDA regulations. Documents must be linked to other processes to provide a single source of truth. Linking to CAPA, change control, employee training, and supplier management reduce compliance and safety risks.
An automated QMS that integrates these key capabilities is essential, helping companies maintain a state of audit readiness while also ensuring only safe, high quality foods ship from their facilities.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharma, biotech, medical device, food, & beverage, and manufacturing.