Process Validation – Systematically Evaluating Critical Processes
FIT Process Validation is a practical workshop format for your team in the food industry. This format is designed for managers in quality management, production, and engineering. The focus is on your specific processes, documentation, and data.
When is FIT Process Validation useful?
- New products, recipes, packaging, or equipment are changing your process requirements.
- Documentation is missing or the validation status is unclear ahead of audits or regulatory inspections.
- Shelf-life issues, customer complaints, spoilage, or mixing errors necessitate a review.
- There is uncertainty within the team regarding the scope of validation, experimental design, or acceptance criteria.
- Process changes require an assessment of revalidation needs.
- Multiple production lines or sites need to operate according to a standardized validation approach.
These processes can be the focus of FIT
- Thermal preservation:Pasteurization, sterilization, UHT, and hot filling – including temperature-time combinations, F/P values, and worst-case conditions.
- Aseptic filling:Cleaning and sterilization of equipment and packaging, packaging and seal integrity, as well as sterile chambers and hygiene zones.
- Filling and mixing processes:Dosing accuracy, mixing time, homogeneity, measuring points, and batch traceability.
How FIT Process Validation works
- Impulse – clarifying the technical foundation
We define validation, verification, and monitoring, and discuss the requirements relevant to your operations in the context of HACCP, IFS Food, BRCGS, FSSC 22000, or ISO 22000. Your team will establish a common foundation for critical process parameters, appropriate verification methods, experimental design, and acceptance criteria. - Joint Review – assessing the current status
Together, we examine process workflows, existing validation reports, product and process specifications, HACCP documentation, and process records. Depending on the focus, we also look at equipment, measurement technology and calibration, hygiene zones, dosing, or homogeneity verification. This reveals what is already documented and where evidence is missing. - Review & Fix – prioritizing gaps and planning actions
In the improvement workshop, we prioritize the gaps and develop the next steps: validation matrix, criteria for planned trials, measures, responsibilities, and deadlines. We clarify revalidation triggers and integration into HACCP, quality management, and change management.
These are the results you will take away
- Process validation assessment:documented validation status with gap analysis.
- Validation matrix:overview of critical processes, validation needs, and priorities.
- Template for validation plan and protocol:structure for target values, acceptance criteria, experimental design, and evaluation.
- Action plan:prioritized steps with responsibilities and deadlines.
- Revalidation concept and checklist:triggers, intervals, and checkpoints for re-evaluation.
- Training concept:foundation for training on validation, measurement technology, and change management.
Optionally expandable
On-site support for practical validation trials—such as temperature distribution, heat penetration, or media fills—can be arranged as an additional service. Further options include in-depth analysis of thermal processes or aseptic filling, validation of cleaning and disinfection, measurement and calibration concepts, cross-site harmonization, and audit preparation.
The assessment and templates provide the foundation for the next steps. They do not replace the efficacy evidence required for your specific process.
It is designed for managers in quality management, production, and engineering at food companies who want to jointly evaluate the validation status of critical processes. This format is particularly suitable for new or modified processes, incomplete documentation, or when there is uncertainty within the team.
FIT includes expert input, a joint review, and an improvement workshop. Support for practical validation trials, such as temperature distribution, heat penetration, or media fills, is arranged separately. The assessment and templates do not replace the required efficacy evidence.
Existing validation reports, product and process specifications, hazard analysis and HACCP plans, as well as process records and information on measurement technology are helpful. For your initial inquiry, a brief description of your process and the current situation is sufficient.
The duration and effort depend on the number and complexity of the processes, the available documentation, and any desired additional services. Once we have clarified your starting point, we will agree on the scope. A target date helps with planning.
Dr. Andrea Dreusch and her team are coming forward with an initial professional assessment.
Confidential · Non-binding · Response within 24 hours