GFSI Overview (BRC, SQF & FSSC 22000)

Transcription

1 GFSI Overview (BRC, SQF & ) Timothy Newbold Manager, Food Safety and GFSI Education 2012 What is it really? The GFSI benchmarking document defines requirements for benchmarking process defines qualifications for accreditation of audit company defines qualifications for certification of auditors Defines the key audit elements that must be met identified within the Standard document May not be reproduced without written permission. GFSI Benchmarked Standards Each scheme is a little different Objective is the same Certification requires compliance with each clause Auditor makes decision on non-conformance clearance Non-conformance clearance is time sensitive Non-conformances must be cleared to get certification GFSI Benchmarked Audits There are 12 primary manufacturing Standards that are currently fully benchmarked against the GFSI standard. Examples are: BRC Global Standard for Food Safety (British Retail Consortium) SQF (Safe Quality Food Institute) - (ISO22000, ISO/TS , PAS223) IFS Food (International Featured Standards) GFSI Philosophy Commonalities Once certified Accepted by All Based on GFSI requirements all standards must have minimally: Management Commitment HACCP Pre-requisite programs - (general GMP s) Complaint Management Internal Audit Program Business Continuity Plan Product Recall and Withdrawal Procedures Supplier Approval Training Program 1

2 Common Strengths The benchmarked standards are globally recognized standards that are based on defined criteria that are accepted by retailers. The documentation requirements are very detailed and stringent. Program requirements are also stringent, as are the record requirements to demonstrate that the program is in place and executed as stated. Common Strengths Consistency in evaluation of content and program requirements is assured by the benchmarking process Audit execution is overseen by independent accreditation bodies such as UKAS (UK) or ANSI (USA) Common Strengths The audit goes beyond the Food Safety / GMP inspection through a more in-depth review of management commitment, quality systems, product control procedures, process control, additional elements with respect to personnel. The requirement for certification is that all nonconformances must be cleared in order to obtain the certification. Common Strengths The audit emphasis is on documentation The plant floor evaluation is designed to evaluate implementation of programs, procedures and documentation as they are written (objective evidence). Corrective actions are time sensitive Differences from GMP Inspection Emphasis is documentation vs current conditions ( Inspection ) Moderate emphasis on GMP detail It is a compliance audit where consulting is not allowed Differences from GMP Inspection The auditor is very limited in conversation of non conformances What is wrong and why only Non conformances are time sensitive Non conformances must be closed before certification 2

3 BRC (Issue 6) British Retail Consortium OVERVIEW BRC Overview Focus is on 50% documentation and 50% physical inspection (on site). Goal is minimum of 40% time spent on physical inspection. If a non-conformance is issued, a corrective action must be completed within 28 days of the audit All non-conformances must be cleared before a certificate can be issued BRC Audit Process 4 Audit types Enrollment, Announced, Unannounced, Split GMP Unannounced, Document Review - Announced BRC audit is conducted on site Audit length plant size is considered Minimum days (+ report writing time) May be more time if off site storage is audited and inspected BRC Sections 1. Senior Management Commitment and Continual Improvement 2. The Food Safety Plan HACCP 3. Food Safety and Quality Management System 4. Site Standards 5. Product Control 6. Process Control 7. Personnel BRC Non-Conformances Three levels of non-conformances: Critical Major Minor Clearance of Non-Conformances Majors and Minors must be cleared in 28 days Photographs Written documents If a cleared Minor non-conformance is seen the next year, it can become a Major nonconformance 3

4 BRC Grading Criteria A A+ Unannounced B B+ Unannounced C C+ Unannounced BRC Grading Criteria Example: Grade of A: No Critical, No Major, 10 or less Minor NC. Clear in 28 calendar days 12 month audit frequency No Grade BRC Grading Criteria Example: Grade of B: 1 Major (not against a fundamental clause), and 10 or less Minor NC OR 0 Major, Minor NC Clear in 28 calendar days 12 month audit frequency BRC Grading Criteria Example: Grade of C: Minors 1 Major (not against fundamental ) and minors 2 Major (not against a fundamental ), and 1-20 Minors Required 6 month surveillance audit SQF CODE (Edition 7.1) Safe Quality Food Institute OVERVIEW SQF CODE (Edition 7.1) SQF (Safe Quality Food) program is based on the principles of HACCP, Codex, ISO and Quality Management Systems Program implementation at the plant level must be under the direction of an SQF Practitioner Demonstrate knowledge of SQF standard Highly recommended practitioner attend a course Demonstrate formal HACCP training 4

5 SQF CODE (Edition 7.1) SQF Code is for Food Manufacturers and Distribution Level 1 Level 2 Level 3 SQF Levels There are 3 different certification levels that can be obtained for each of the codes: Level 1 - Food Safety Fundamentals Not GFSI certifiable Level 2 Food Safety Fundamentals and HACCP Based Food Safety Plans Level 3 - Comprehensive Food Safety (Level 2) plus Quality Management System SQF Audit Process The audit process is in 2 parts: Part 1 is submission of the facility s SQF program for a desktop audit evaluation (on or off site). Billed as 1.5 audit day. Part 2 is an in-plant evaluation of implementation of the SQF program as written and review of execution of the programs. Usually requires audit days. SQF Audit Process The desktop review is the assessment of the plant s written Food Safety / Quality programs. The on-site audit is the plant s adherence to these programs. On-site time is 50% physical, 50% audit. SQF Sections Scope, References, Definitions SQF System Elements Management Commitment Document Control and Records Specifications and Product Development Attaining Food Safety SQF System Verification Product Identification, Trace and Recall Site Security Identity Preservation Training SQF Modules Modules for Food Safety Fundamentals Module 3 Compound Feed Production Module 4 Pet Food Products Module 5 Agricultural Animal Products Module 6 Aquaculture Fish Farming Module 7 Agricultural Plant Production Module 8 Agriculture Grain Farming Module 9 Pre-processing of Animal Products Module 10 Pre-processing of Plant Products 5

6 SQF Modules Modules for Food Safety Fundamentals (cont d) Module 11 GMP s Food Processing Module 12 Transport and Distribution Module 13 Food Packaging Module 14 N/A - Food Brokers and Agents Module 15 N/A Food Catering, Wholesale, and Retail Module 16 Multi site companies managed by a central location SQF Non-Conformances Rating Examples: E Rating - Score of / < 5 Minors G Rating - Score of / >4 Minors or 1 Major & < 4 Minors C Rating -Score of / >14 Minors, 1 Major & > 5 Minors, or 2 Majors and < 10 Minors Clearance of Non-Conformances Major must be cleared in 14 days Minor must be cleared in 30 days SQF Rating G Rating (Good) 12 monthly re-certification audit E Rating (Excellent) 12 monthly re-certification audit C Rating (Comply) always requires a 6 month surveillance audit F (Fails to Comply) No Certificate Issued Food Safety System Certification OVERVIEW ISO ISO/TS * Manufacturing (*Previously PAS220) or PAS 223(Packaging) ISO is a Food Safety Management System ISO (PAS220) / PAS223 Publically Available Specification A guideline for details of prerequisite programs to compliment ISO

7 ISO Sections ISO Sections Scope, References, Definitions General Requirements 4.2 Documentation Requirements Management Commitment Food Safety Policy Food Safety Management System Planning Responsibility and Authority Food Safety Team Leader Communication Emergency Preparedness and Response Management Review Provision of Resources Human Resources Infrastructure Work Environment General Prerequisite Programs (PRPs) Preliminary steps to enable Hazard Analysis Hazard Analysis Establishing the Operational Prerequisite Programs (oprp s) Establishing the HACCP Plan Updating of preliminary information and documents specifying the PRPs and the HACCP Plan Verification Planning Traceability System Control of Non-Conformity General Validation of Control Measure Combinations Control of Monitoring and Measuring Food Safety Management System Verification Improvement PAS 220 Sections 1-3. Scope, References and Definitions 4. Construction and layout of buildings 5. Layout of premises workspace 6. Utilities air, water, energy 7. Waste disposal 8. Equipment suitability, cleaning and maintenance 9. Management of purchased materials 10. Measures for prevention of cross contamination 11. Cleaning and Sanitizing 12. Pest Control 13. Personnel Hygiene and Employee Facilities 14. Rework 15. Product Recall Procedures 16. Warehousing 17. Product Information / Consumer Awareness 18. Food Defense, Biovigilance and Bioterrorism TWO STAGES TO THE AUDIT: STAGE I: Onsite (Desktop Review to confirm development) Identification of Prerequisite Programs (PRPs) and how appropriate they are to the business and how they conform to PAS 220/PAS 223 Processes and methods for identification and assessment of the organizations food safety hazards and subsequent selection and categorization of control measures Food safety legislation is in place for relevant sector of the organization STAGE I: Onsite (Desktop Review cont d) Food Safety Management System (FSMS) designed to achieve food safety policy FSMS implementation program justifies proceeding to the audit (stage 2) Validation, verification and improvement programs conform to the requirements of the ISO standard FSMS documents and arrangements are in place to communicate internally and with relevant suppliers, customers and interested parties STAGE II Onsite (Implementation Audit) Information and evidence for conformance to each clause of the ISO standard and PAS 220 /223 guidelines Implementation of PRPs, oprp s and HACCP Monitoring, measuring, reporting and reviewing objectives of the FSMS The FSMS and performance with regard to legal compliance 7

8 STAGE II Onsite (Implementation Audit cont d) Operational control of processes Internal auditing and management review Management responsibility for food safety policy Links between the requirements of ISO 22000, policy, food safety objectives, prerequisites and HACCP, legal requirements, responsibilities, competence of personnel, operations, procedures, performance data and internal audit findings and conclusions. Non-Conformances Major a situation which poses a significant risk to food safety evidence of non-compliance with a relevant regulatory requirement failure to adequately address one or more system elements relates to a group of minor non-conformances indicating similar failure to address a specified requirement of the Standard a situation where there has been a persistent failure to address a minor nonconformity reported on previous audits. Non-Conformances Minor A situation indicating a weakness in the implementation of a system or procedural requirements which does not indicate a system breakdown or raise doubt that the products or services will meet requirements. Non-Conformances Observation Applies where no evidence of an actual nonconformance has been found, but there is: a situation which, if not corrected, could lead to a non-conformance conformance with requirements, but there is an identified opportunity to improve the system or part of the system Non-conformances STAGE I Audit - Must clear in 180 days to proceed to the Stage II Audit STAGE II Audit Must clear in 30 days FSSC Audit Timing Three year cycle Year 1 = Certification audit Year 2 = Surveillance audit Year 3 = Surveillance audit Year 4 = Recertification audit 8

9 Recertification Audit Covers: Prove continuous maintenance of FSMS Internal audits and management review Actions taken on non-conformances raised at the previous audit Treatment of complaints Effectiveness of the FSMS with regard to achieving the Food Safety Policy Recertification Audit Covers: (cont.) Progress of planned activities aimed at continual improvement Continuing operational control and implementation of PRPs and HACCP Review of any changes Use of marks and/or any other reference to certification Getting Started: ALL GFSI STANDARDS Getting Started Register with Standard Owner Pay registration Fee Select Certification Body AIB Assign Lead Person or SQF Practitioner Select your GFSI Team Provide GFSI Training Perform GAP Assessment AIB Set Certification Date - AIB Improve Systems Perform Pre-assessment AIB Full certification General Timing 7-9 months Pre-assessment BRC is typically two days. A typed report is not required, just a list of the non-conformances. SQF is also two days; the desktop review is done at the same time on site (first day) followed by a sample of the factory (second day) to ensure that all the clauses of the Standard are covered., a gap assessment can be done with the desktop audit where a limited physical inspection is conducted. Thank You Timothy Newbold Manager Food Safety & GFSI Education tnewbold@aibonline.org May not be reproduced without written permission. 9