Color-Coding as a Preventative Strategy 21 CFR 117 Subpart B: Current Good Manufacturing Practice §117.10 Personnel §117.20 Plant and grounds §117.35 Sanitary operations §117.37 Sanitary facilities and controls §117.40 Equipment and utensils §117.80 Processes and controls §117.93 Warehousing and distribution §117.95 Holding and distribution of human food by-products for animal food §117.110 Defect action levels 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls §117.135 (c) on Preventive Controls: (1) Process controls (2) Food allergen controls (3) Sanitation controls (4) Supply chain controls (5) Recall plan 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls §117.135 (c) : (6) Other controls i.e. procedures, practices and processes that qualify as Preventive Controls Standard Operating Procedures (SOPs) Food Safety Plan Color Coding as a Best Practice There are three main ways a color-coding plan can fit into a food safety management system: 1. As part of the Standard Operating Procedures: A color-coding plan can specify the colors used for scoops for handling different products within an allergen SOP, or cleaning brushes to be used for different surfaces within a Sanitation Standard Operating Procedure (SSOP). 2. As a Preventive Control within a Food Safety Plan: For this, the plan must be validated or justified, monitored, verified, and reviewed as a food safety control. 3. As a Standalone Color-Coding Plan: This could reference other procedures and can also follow the same format as the food safety plan. The facility may decide to reference color-coding within their Current Good Manufacturing Practices (CGMPs), Preventive Controls, or Best Practices framework as long as there’s consistency and a clear process of justifying, verifying, and reviewing the program. Developing a Color-Coding Plan The steps to establishing any preventive controls are as follows: 1. Conduct a Comprehensive Hazard Analysis: Do you have areas where there’s a chance of allergen cross-contact or cross-contamination? These could be the right place to establish color-coding zones or use color-coded implements. 2. Evaluate the Applicability of Color-Coding: Will color-coding prevent issues? If you need to keep scoops separated because they’re not easily identifiable, it would be an appropriate use of color-coding as a preventive control. If raw product is touching finished product because there isn’t enough workspace, color-coding may not help. A. Conduct a Comprehensive Hazard Analysis B. Evaluate the Applicability of Color-Coding C. Establish Control Measures, Preven ti ve Controls and Pr actices D. Set the Monitoring, Corre cti v e Action, Ve rifi ca tion, and Review Criteria for the Plan E. Educate, Train, and Refresh the Employees on the Plan 3. Establish Control Measures, Preventive Controls, and Practices: Color-coding may be employed as part of the current Good Manufacturing Practices, or as a risk-based Preventive Control, or as an industry best practice. 3
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