Food Safety Management System Requirements Comparison - Private & Public Sector Programs - Version 4 19 June 2013

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Sabina Cunningham
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1 Version 4 19 June v 6.2 January Generic ed 4.1 i FSM 1 ii iii Food Safety Plan iv Eligibility - 3 v ed Preventive Control Plan 2.7 vi ed Preventive Control Plan PCP p. 11 vii Meet scheme or standard requirements 4.1 FSM 1 Not Applicable (NA) Eligibility 3a FS Policy & 5.2 FSM 2 Not Specified () FS FSM 3 NA NA Measurable Objectives related to food safety policy Include statutory & regulatory requirements in system FSM 2 Annex B - Introduction 5.1 [general reference in Forward p. 11] See below See below Eligibility - 2 See below Could include measurable regulatory performance criteria See below Page 1 of 17

2 Version 4 19 June v 6.2 January Obligation Outsourced Processes See above See above FSMA & Regulations Meat & Fish, etc Acts & Regulations See above Safe Food for Canadians Act & 1.1, 1.2, 1.3.1, (b) Safe Food for Canadians Act & Regulations 4.1 FSM 17 PRP -H 2.1 PCP pp 11 - ed specifications for inputs & services Control Procedure Record Control Procedure Management Responsibility FSM 9 PRP H2.1 Annex B FSM Eligibility FSM Eligibility 5 & various PRPs 5.1 FSM requires qualified individual s required Records required Eligibility (f) (implied not stated) 1.1.1, s required PCP pp. 11- (implied) Page 2 of 17

3 Version 4 19 June v 6.2 January Management Commitment 5.1 FSM requires owner signature on FS Plan See above Obligation Eligibility in context of enforcement / Annex A.1 in limited context of license application See above Obligation System Planning Defining responsibility & authority 5.3 Eligibility FSM [qualified individual] See above Obligation PCP pp Team Leader 5.5 EL [qualified individual] Eligibility 3d (implied in context of management review) PCP pp Page 3 of 17

4 Version 4 19 June v 6.2 January External Communication (excludes recall) Customer complaints Internal Communication Emergency Preparedness Management Review Provision of resources Human Resources, including Competence & Training FSM 18 PRP F Annex B Annex A in context of emergency contact info 5.8 FSM 6 / System annual review / review Eligibility FSM Eligibility FSM Eligibility GMP EL PRP - D (f) 2.7 (implied) Annex B Question 12 p. raises matter for input PCP p. 12 PCP pp. 11- (implied) Page 4 of 17

5 Version 4 19 June v 6.2 January Infrastructure 6.3 FSM Annex B Work 6.4 FSM Environment Planning & realization of safe product Prerequisite Programs (PRP) Building construction GMP EL 1, 2, 3, PRP - A Annex B , 5.2, , 5.3 Premise layout GMP EL 1, 2, 3, 4 Utilities (air, water, etc) GMP EL , PRP - A Annex B 5.1 PRP - A Annex B 5.3 & , , 5.2, , 5.3.5, , 5.3.5, 5.4 Page 5 of 17

6 Version 4 19 June v 6.2 January Supporting services (waste, sewage, etc) GMP EL PRP - A Annex B 5.4, Suitability of equipment & maintenance GMP EL 5 & PRP - C Annex B , 4.2, , 4.2 Purchasing FSM PRP - B Annex B 1.1 & 1.2 (a) Supplier approval FSM 16 / Comments invited PRP H 2.1 Annex b 1.3 only in context of imported ingredients 1.1.1, , 6 Implied PCP p.12 refers to other supply chain segments that need to be included in a PCP Page 6 of 17

7 Version 4 19 June v 6.2 January Analysis of inputs (lab testing to 17025) Handling of product (storage, transport, etc) Cross contamination [not lab to 17025] FSM DEL GMP EL 10 GMP EL 15 / FSMA raises in context of analyses re: regulatory tests (a)(4) (e) 117.0(c)(3) GMP EL (b)(6) 117.5(d)(3) PRP H 2.1 [partial] (d) [not lab to 17025] PRP - B Annex B - 6 PRP - E Annex B 5.2 (c) , , ,1.1.3, 1.2.1, 3.2, 5.2.3, , 1.1.2, 3.2, 5.3.3, 6 Pest control GMP EL , Annex B 2.2 & Page 7 of 17

8 Version 4 19 June v 6.2 January Personnel Hygiene Employee facilities Cleaning & sanitizing Generic Processes & controls Rework Product recall GMP EL PRP - D Annex B GMP EL PRP - A Annex B 5.2 (f) GMP EL PRP - E Annex B 2.1 & Annex B & & , 3.2, , 3.2, , , , 2.2, Annex 2-2.1, 2.2, , GMP FD , PRP F , 1.1.2, , 6 FSM PRP F Annex B 7.2 Recall testing FSM PRP F1 Annex B Annex Annex Page 8 of 17

9 Version 4 19 June v 6.2 January Warehousing GMP EL PRP - B Annex B - 6 Product information &/or labelling FSM PRP F2 Annex B 1.2 (b) , , 6 PCP p , 1.1.2, , , Allergen Control GMP M (d)(2) Food defence FSM 21 FSMA - voluntary PRP - G (c) [? Viewed as chemical hazard] Page 9 of 17

10 Version 4 19 June v 6.2 January Hazard Analysis ed Record FS Team appointed FS Team competence Selection of methodology Product Inputs documented Modified Codex approach covering all control measures Codex Approach Modified NACMCF approach Modified Codex Approach Modified approach based on Codex EL (a)(2) 3.2 Eligibility 3c Hazard analysis based on Codex principles & standards 3 Preventive Control Plan Systematic approach based on Codex principles [could be site specific or generic (based)] PCP pp EL 1 Recommend (Rec) Eligibility 3d PCP p Rec PCP - pp Annex Codex AHA Forms PCP pp. 11- approach principles forms (refers to Codex) Rec 12 steps EL ( c) Form 2 Annex B 1.1 (a) PCP - pp. 11- Page 10 of 17

11 Version 4 19 June v 6.2 January End Product Characteristics EL ( c) Form 1 Annex B 1.1 (b) PCP - pp. 11- Intended Use EL ( c) Form 1 PCP pp. 11- Flow Diagrams EL ( c) Form 3 Annex B 1.1 (c) PCP - pp. 11- Plant schematic/ Operation Form 4 PCP - pp. 11- Diagram Description of External requirements Description of Process Steps & Control Measures Hazard Identification & Acceptable Levels Hazard Assessment Hazards not controlled Selection of Control EL ( c) Form 5 Annex B 1.1 (c) [B,C,P] [A] EL (b) [B,C,P,R viii ] [B,C,P] [A] Form 5 [B,C,P,A] (a) Annex Annex PCP - pp EL ( c) Form (a) PCP - pp Form 6 Form [PRP, EL Form 5 OPRP, CCP] [CCPs] [preventive [PRPs, (a) Page 11 of 17

12 Version 4 19 June v 6.2 January Measures controls] process controls, OPRPs, CCPs] Establishing PRPs series of PRPs Establishing OPRPs GMPs prescribed [narrowly defined as allergens, nutrients, food additives & processing aids] Establishing CCPs 7.6 EL Establishing Process Controls (multiple steps) Similar to OPRPs Form (a) Annex B all applicable Form (a) Annex , 2, 3, 4, 5, 6 1, 2, 3, 4, 5, 6 PCP pp Annex B - 1 PCP pp. 11- Annex Annex Page 12 of 17

13 Version 4 19 June v 6.2 January Updating Preliminary Information Eligibility (a) Permits Externally Developed Combinations of Control Measures (i.e. -based) as option to site specific analysis 1 Scope in EDCCM must be developed using Sections 7 & 8 Yes CanadaGAP GlobalGAP Yes (a) No - site specific No site specific Note: is considering developing model systems and tools to assist MSMEs Note: is proposing to help MSMEs with models, guidance, etc PCPs pp & 30 Verification Planning - PRPs Verification Planning - OPRPs Verification Planning - CCPs Verification Planning Process controls , Eligibility 3a (d) 7.8 but (d) 7.8 EL Eligibility 3c (d) (d) PCP p. 11 PCP p. 11- PCP p. 11- PCP p. 11- Page of 17

14 Version 4 19 June v 6.2 January Traceability System 7.9 FSM DEL 23 US Bioterrorism Act & Sec 204 FSMA PRP F Annex B 7.1 Control of nonconformity Corrections Eligibility 3a, 3b, 3c Corrective Actions Potentially unsafe product Evaluation for release FSM Eligibility 3a, 3b, 3c PRP D, E, F (e) (e) FSM Annex B FSM (e) Traceability pp PCP pp. 11- PCP pp PCP pp Disposition of nonconforming product Withdrawal or Recall FSM Annex B FSM PRP - F Annex B Page 14 of 17

15 Version 4 19 June v 6.2 January Validation, Verification & Improvement Validation of control measure combinations Monitoring & Measuring 8.2 (OPRPs & CCPs) (a) With limited exceptions 3.3 (CCPs) Eligibility 3c [CCPs only] (a) 8.3 FSM PRP - B (c) Verification Internal Audit FSM 11 / maybe covered by (d) Evaluation of individual verification results Analysis of results of verification activities Continuous Improvement Eligibility 4 [suggested] FSM (f) PCP p Page 15 of 17

16 Version 4 19 June v 6.2 January Updating documented FSM [3 years] Prepared for the Canadian Supply Chain Food Safety Coalition: Albert Chambers Monachus Consulting [annual] Eligibility 4 [annual] (f) i For standards, the numbered references are to the clauses of is a technical specification that sets out additional requirements for prerequisite programs (PRPs) for food manufacturers. ii For the references are to key elements set out in Part III of the v 6.2. FMS = food management system. GMP = good manufacturing practice. Other letters indicate scope or benchmarking category (e.g. E covers various types of food processing). Sixth_Edition_Version_6.2.pdf iii US FDA published its regulations for food businesses under the Food Safety on Act Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food in the Federal Register on 4 January. The sections referenced can be found starting on p A document prepared by Leavitt Partners which compared FSMA requirements with SQF requirements was also utilized to identify relevant FSMA requirements REPORT-April-.pdf iv references are from the accessed on 6 January 201 at v AHA references are to the program Standard version accessed on 6 January at vi References are to Improved Food Model Revised Draft RDIMS # (28 March ) accessed on 22 May at: vii References are to A Framework for Federal Food : Discussion (June ) accessed on at: Page 16 of 17

17 Version 4 19 June v 6.2 January Page 17 of 17

Are You Ready for FSMA? Janet Raddatz VP Quality & Food Safety Systems Sargento Foods Inc. WAFP June 12, 2013

Are You Ready for FSMA? Janet Raddatz VP Quality & Food Safety Systems Sargento Foods Inc. WAFP June 12, 2013 New Responsibilities for Food Companies Impacting daily operations in all registered facilities,