Specifications:
- Deviation: Using ingredients that do not meet the specified quality or purity standards.
- Example: A batch of cereal contains an additive that exceeds the specified concentration limits, leading to potential health risks.
Safety Analysis:
- Deviation: Failing to identify a potential hazard during the hazard analysis.
- Example: Overlooking a possible contamination risk from a nearby allergen processing line, which later causes cross-contamination.
Purchasing Requirements:
- Deviation: Sourcing ingredients or equipment from unapproved or substandard suppliers.
- Example: Purchasing raw materials from a supplier that does not follow Good Manufacturing Practices (GMP), resulting in contaminated ingredients.
Good Manufacturing Practice (GMP):
- Deviation: Lapses in hygiene and sanitation practices in the production area.
- Example: Employees not wearing appropriate protective clothing or not following hand-washing protocols, leading to contamination of the food product.
Physical Systems Hazard Control:
- Deviation: Equipment not being maintained or calibrated as required, leading to malfunction.
- Example: A packaging machine that fails to seal packages properly, increasing the risk of product contamination and spoilage.
Recall System:
- Deviation: Ineffective product coding and tracking, making it difficult to recall contaminated products.
- Example: A recall is initiated, but due to poor record-keeping, some batches of the contaminated product remain on the market.
Contract Manufacturing:
- Deviation: Contract manufacturers not adhering to the same safety standards as the contracting company.
- Example: A contracted facility does not follow the HACCP plan, resulting in a batch of cereal with undeclared allergens.
Facilities Auditing:
- Deviation: Infrequent or superficial audits that fail to identify critical safety issues.
- Example: An audit misses signs of pest infestation in a storage area, leading to widespread contamination of the food products.
Customer Complaints:
- Deviation: Customer complaints not being adequately monitored or addressed.
- Example: Repeated complaints about foreign objects in cereal boxes are not investigated thoroughly, resulting in continued occurrences.
Incident Reporting:
- Deviation: Failing to report or inadequately reporting deviations from normal operations.
- Example: An incident of equipment malfunction that affects product safety is not reported to senior management, delaying corrective actions and potentially causing a health hazard.
To address these deviations, companies must implement corrective actions such as retraining staff, revising procedures, improving supplier vetting processes, enhancing equipment maintenance schedules, and conducting more rigorous audits. Consistent monitoring, thorough documentation, and proactive management are essential to minimize deviations and maintain a robust food safety program.
Examples of Deviations in a 10-Point Safety Program