FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing ...

1 Version FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program ( edition ) FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version i PREFACE This document is intended to provide general Guidance for facilities and auditors for FSC36 Safe FEED/SAFE Food Certification Program. This Guidance will assist facilities as they implement the various clauses as they prepare for an audit. The purpose of FSC36 Safe FEED/SAFE Food implementation is not only to achieve certification, but to assure consistency and promote a culture of continual improvement of a Supplier s quality and feed safety program. The Guidance is not intended to cover every possible scenario that may be seen across the feed industry.

2 It is not definitive but provides a general guide of what could be acceptable to meet the requirements for a particular clause or area. Effective implementation of FSC36 Safe FEED/SAFE Food requires the commitment of the site management and the constant involvement and participation of site staff to maintain the quality and feed safety program. The American Feed Industry Association (AFIA) is grateful to its Quality Committee and numerous members that reviewed and contributed to this document. This document has been revised and shall be referred to as FSC36 Safe FEED/SAFE Food version FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version ii TABLE OF CONTENTS Page PREFACE .. i SECTION Introduction .. 6 SECTION Registration and Certification.

3 6 AFIA Alignment with SQFI .. 6 Registration and Certification Steps .. 7 Audit Duration Guide .. 8 System Elements .. 9 Nonconformities and Corrective Actions .. 10 Opportunities for Improvement .. 11 The Audit Report .. 11 Responsibility for the Certification Decision .. 11 Audit Score and Rating .. 11 Suspending Certification .. 12 Complaints, Appeals and Disputes .. 13 SECTION 3 Implementation Process .. 13 SECTION 4 Introduction to this Guide .. 13 Purpose and Scope of this Guide .. 13 The Structure of the FSC36 Safe FEED/SAFE Food Requirements .. 14 Format of Guidance Information .. 14 SECTION 5 Requirements for FSC36 Safe FEED/SAFE Food Certification .. 15 1 MANAGEMENT COMMITMENT AND RESPONSIBILITY .. 15 Management Policy (M) .. 15 Management Responsibility (M) .. 16 Responsibility, Authority and Communication (M).

4 17 Management Review .. 18 Management Review Process .. 18 Management Review Inputs and Outputs .. 19 Records for Management Review .. 20 2 QUALITY AND FEED SAFETY MANAGEMENT SYSTEM .. 20 General Requirements .. 20 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version iii Quality and Feed Safety Manual (M) .. 21 Document Control (M) .. 22 Records (M) .. 23 3 PERSONNEL AND TRAINING .. 24 Competence and Job Descriptions (M) .. 24 Training and Awareness (M) .. 24 Personnel Policies and Behavior .. 26 Personnel Facilities .. 27 Visitors .. 28 4 INFRASTRUCTURE .. 29 Facility Construction and Surfaces .. 29 Equipment and Maintenance .. 30 30 Maintenance .. 31 Lighting and Work 33 Pest Management and Control.

5 34 Pest Management (M) .. 34 Pest Control Chemicals (M).. 35 Pest Management Personnel .. 35 Cleaning and Housekeeping (M) .. 36 Exterior .. 37 5 PRODUCT REALIZATION .. 38 Product Development .. 38 Packaging and Materials Receiving Processes .. 39 Receiving Processes for Packaging Materials .. 39 Receiving Processes for Raw Materials and Ingredients .. 40 Equipment at Receiving .. 41 Manufacturing Processes .. 41 Process Control (M) .. 41 Control of Raw Materials and Ingredients .. 42 Product Release (M) .. 43 Finished Products .. 44 Finished Products Specifications (M) .. 44 Product Formulation (M) .. 44 Customer Related Processes .. 45 Customer Requirements .. 45 Customer Communication .. 46 Labeling (M) .. 47 Nonconforming Products and Materials (M) .. 48 Rework (M).

6 49 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version iv Inventory Stock Rotation .. 50 Storage of Materials and Finished Products .. 50 Storage of Raw Materials and Ingredients .. 50 Storage of Packaging .. 52 Storage of Finished Products .. 52 Storage of Nonconforming Materials .. 53 Bulk Storage of Ingredients and Finished Products .. 54 Storage of Hazardous Chemicals .. 55 Hazardous Chemical Storage Process (M) .. 55 Hazardous Chemical Storage Area (M) .. 56 Loading, Transport and Unloading 56 6 PURCHASING PROCESSES AND CONTROLS .. 57 Vendors for Incoming Goods and Services .. 57 Approved Vendors (M) .. 57 Unapproved Vendors or Temporary 58 Material and Packaging Specifications (M) .. 59 Contract Service Providers.

7 60 Specifications for Contract Service Providers .. 60 Contract Manufacturing .. 60 7 VALIDATION AND VERIFICATION .. 61 Responsibility, Frequency and Methods .. 61 Validation Effectiveness .. 62 Equipment Calibration .. 63 Verification Schedule and Monitoring Activities .. 64 Product Sampling and Inspection .. 65 Processes for Product Sampling .. 65 Inspection and Analysis of Raw Materials and Ingredients .. 66 Inspection and Analysis of Finished Products .. 67 Internal Audits .. 68 Internal Audit Process .. 68 Internal Auditors .. 69 Internal Audit Corrective Actions .. 70 Product Identification (M) .. 71 Product Traceability (M) .. 71 Animal Food Defense and Biosecurity Plan .. 72 8 ANIMAL FOOD SAFETY PLAN .. 74 Animal Food Safety Fundamentals (M) .. 74 Animal Food Safety Plan.

8 74 Animal Food Safety Plan Responsibility (M) .. 74 Process Flow Diagram .. 76 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version v Hazard Analysis of Processes (M) .. 76 Hazard Analysis of Materials (M) .. 77 Preventive Controls (M) .. 77 Corrective and Preventive Actions (M) .. 78 Regulatory Requirements (M) .. 79 Recall Plan (M) .. 80 Waste Disposal .. 82 Water and Air .. 82 9 FSC36 SAFE FEED/SAFE FOOD SEAL REQUIREMENTS .. 83 Compliance with Safe FEED/SAFE Food Seal Licensing Agreement .. 83 APPENDIX A .. 85 APPENDIX B .. 90 FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version 6 SECTION Introduction The purpose of the Guidance document for FSC36 Safe FEED/SAFE Food is to assist Suppliers with designing, Developing , implementing and maintaining a quality and feed safety program that complies with the desired requirements as well as assist auditors with auditing Suppliers seeking certification for FSC36 Safe FEED/SAFE Food.

9 This is not a definitive document and applicable in every situation. Suppliers, consultants and auditors are required to understand animal food safety (and quality, where applicable) risks in the feed industry in order to effectively control those risks. The document includes the following: Registration and certification process Implementation process Introduction to this Guidance document Guidance document for FSC36 Safe FEED/SAFE Food Glossary Rules for using the Safe FEED/SAFE Food seal or logo Terms used in this document are defined in Appendix A: Glossary for FSC36 Safe FEED/SAFE Food Guidance Document Version SECTION Registration and Certification AFIA Alignment with SQFI AFIA aligned with Safe Quality Foods Institute (SQFI) to administer the Safe FEED/SAFE Food certifications in October 2013.

10 AFIA and SQFI signed a Joint Program Implementation and Marketing Agreement to bring AFIA certification programs into SQFI family of programs. SQFI is recognized by retailers and foodservice providers around the world who require a rigorous, credible animal food safety management system. SQFI is recognized by the Global Food Safety Initiative (GFSI) and links primary production certifications to food manufacturing, distribution, and agent/broker management certifications. GFSI is an approved (benchmarked) choice of third-party food safety certification programs that are required by many in the retail food industry for their Supplier s participation. With the alignment with SQFI, two of AFIA programs administered by SQFI are now benchmarked by GFSI. SQFI code Certification GFSI Benchmarked FSC36 Safe FEED/SAFE Food FSC34 Animal Feed Manufacturing Facility Animal Feed Ingredient Facility FSC32 Pet Food Manufacturing Facility Pet Food Ingredient Facility FSC36 SAFE FEED/SAFE FOOD: Guidance for Developing , documenting , implementing , maintaining and Auditing the Program Version 7 Registration and Certification Steps The requirements for the certifications of FSC34 and FSC32 may be found within the SQF code AFIA maintains the requirements for FSC36 Safe FEED/SAFE Food, which is the purpose of this Guidance document.