February 2014 Kris Middleton Technical Manager, Agri-Food SAI Global Assurance Services

Transcription

1 Introduction to FSSC Food Safety Management System February 2014 Kris Middleton Technical Manager, Agri-Food SAI Global Assurance Services

2 2 Our Presenter Today Kris Middleton Technical Manager Agri-Food, SAI Global Assurance Services Kris has an Honor Bachelor of Science in Toxicology. He is a registered SQF and FSSC Auditor in several categories including meat and poultry, seafood, beverage, distribution, to name a few. Kris uses his extensive knowledge of HACCP principles and applications to assist companies with their quality assurance programs. As Technical Manager, he oversees the implementation and maintenance of the audit programs as well as provides auditor training for all programs. Kris is also a trainer facilitator for FSSC 22000, ISO 22000, and SQF.

3 Purpose Of This Webinar Discuss who and what is FSSC Review the benefits of the FSSC standard Review the basic elements of the scheme Describe what is involved in each of the elements of the scheme Outline how are FSSC audits are completed Review how are certificates issued and what is the scoring of the audit Discuss how does the FSSC standard differentiate from other GFSI standards Q&A

4 4 Current Climate Food safety systems today are not preventing food-borne illness and death Businesses face catastrophic consequences from media-hyped adverse events We depend more on imported food products in our global supply chains Current regulatory framework and inspection cannot secure the food supply chain on its own Retailers and manufacturers, in response to consumer demand, are driving a change to a safer, more secure, and sustainable food supply chain

5 5 Current Climate Food manufacturing is taking a path well travelled by other industries: Aerospace: How did they make it the safest form of travel? Automotive: How did they eliminate defects and improve quality? Electrical: How did they increase safety and reduce deaths? Forestry: How did they demonstrate environmental responsibility?

6 6 Public & Private Sector Responses Codex Alimentarius Commission HACCP Government Initiatives Private Sector Schemes GFSI Benchmarking International Standards System Framework

7 7 Current Trends Mandated compliance by both retailers and manufacturers in the Americas will continue to grow Benchmarking of audit schemes is a good first step Further convergence between food safety standards will happen, like in other industries GFSI (Global Food Safety Initiative) recognized as a benchmark process for food safety management schemes Further inclusion and recognition of 3rd party certification programs in regulation

8 8 Standard Owner for FSSC The Foundation for Food Safety Certification was founded in 2004 Non profit organization Foundation facilitates and owns the schemes and manages its copyright Maintains the license agreements with accredited CBs Incorporates: 68 associated Certification Bodies for FSSC The actual responsibility and authority for the content of the scheme resides with Board of Stakeholders

9 9 Foundation for Food Safety Certification FSSC Board of Stakeholders Standards: - ISO ISO/TS PAS 223 Requirements: - ISO ISO GFSI guidance document

10 10 What are the benefits of FSSC 22000? Fills a gap between ISO 9001:2008 and HACCP Contributes to a better understanding and further development of Codex HACCP Auditable standard with clear requirements System approach rather than product approach Enables the company to demonstrate due diligence

11 11 What is FSSC 22000? FSSC is a Food Safety System Certification based on ISO and ISO TS (PAS 223 for packaging) ISO TS gives the requirements for Prerequisite Programs for food manufacturers. This document was added to ISO to create a system that could be benchmarked by the Global Food Safety Initiative (GFSI) Some large retailers require suppliers to have a GFSI benchmarked scheme It provides a single, internationally recognized food safety management system Scheme operated by the Foundation for Food Safety Certification based in the Netherlands 7,300 sites globally and 700 in the North America

12 12 Elements of FSSC ISO ISO/TS ISO/TS PAS 223

13 13 What is FSSC 22000? FSSC is a Food Safety System Certification based on ISO and ISO TS (PAS 223 for packaging) ISO TS gives the requirements for Prerequisite Programs for food manufacturers. This document was added to ISO to create a system that could be benchmarked by the Global Food Safety Initiative (GFSI) Some large retailers require suppliers to have a GFSI benchmarked scheme It provides a single, internationally recognized food safety management system Scheme operated by the Foundation for Food Safety Certification based in the Netherlands Approximately 1800 certificates with about 300 in the USA

14 14 The content of the scheme Features of the scheme Scope, content, references, terms & definitions Requirements for the food safety management system Food safety management system, PRP s, additional, guidance Requirements for providing certification Approval by the Foundation, accreditation, audit process Harmonization, providing information Requirements for providing accreditation Accreditation process, providing information Regulation for the board of stakeholders

15 15 Who is the scheme for? FSSC is designed for manufacturers who supply their products (i.e. national brands or private label) to major food retailers or their ingredients to food manufacturers Food manufacturers that process or manufacture: Animal products (meat, poultry, eggs, dairy & fish products) [ISO C] Perishable vegetal products [ISO D] Products with a long shelf life [ISO E] Food ingredients such as additives, vitamins and bio-cultures [ISO L] Food packaging material manufacturing [ISO M] For details see FSSC guidance document on certification scopes [ Manufacturers already certified against ISO will only need an additional review against the ISO/TS

16 Compatibility with Other Management Systems ISO 9001 Quality Management Focused ISO Environmental Management Focused OHSAS Occupational Health and Safety Codex HACCP etc. Annex A and Annex B provide cross references to ISO 9001 and HACCP 16

17 17 Relationship between Food Safety Management Systems and ISO 9001:2008 A quality management system such as ISO 9001:2008 includes all quality elements that form part of an organization s operation The majority of food safety standards adopt many of the quality management system principles but with a clear focus on issues relating to the food industry ISO 9001:2008 and a food safety management system should be regarded as complementary ISO 9001:2008 covers how a business is organized and operates effectively A Food Safety Management System addresses specific Food Safety issues

18 18 ISO Food Safety Management System ISO is a Food Safety Management System (FSMS) that uses a management system approach and HACCP requirements. Published August 2005 Published in response to the proliferation of private food safety standards The goal of ISO is to provide one internationally recognized standard that can be applied to any organization in the food chain. Its structure complements the quality management system requirements defined by ISO 9001:2008 Provides an internationally recognized certification program for food safety management systems

19 19 What is ISO 22000:2005? ISO combines generally recognized key elements to ensure food safety along the food chain: Interactive Communication HACCP Principles System Management Prerequisite programs Mgt System Elements HACCP Principles (Codex Alimentarius) Good Manufacturing Practices

20 20 ISO 22000:2005 Scope Normative References Terms and Definitions Food Safety Management System Management Responsibility Resource Management Planning and realization of Safe Products Validation, Verification and Improvement of the Food Safety Management System

21 21 ISO Standard Section 4: Food Safety Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning and Realization of Safe Products Section 8: Verification, Validation and Improvement

22 22 Food Safety Management System PRPs Contracts HACCP Plan Typical FSMS Documents Operating Procedures Operational PRPs Product Specifications

23 23 ISO TS :2009 ISO Technical Specification :2009 replaces BSI PAS 220 (withdrawn 2012) Sets out Prerequisite programs on food safety for food manufacturing Provides detail on PRP's to meet ISO requirement Harmonization of food manufacturer s PRP s Meeting GFSI requirements on PRP s Intended to used in conjunction with ISO not in isolation When combined with ISO becomes the basis for FSSC 22000, a GFSI recognized scheme

24 24 BSI PAS 220:2008 & ISO TS :2009 FSSC secured GFSI benchmarking based on ISO 22000:2007 & BSI PAS 220:2008 ISO TS :2009 is PAS 220 elevated to an ISO standard BSI PAS 220:2008 has been withdrawn ISO TS :2009 replaced PAS 220 starting in 2012

25 25 Who Developed PAS 220:2008/ ISOTS :2009 British Standards Institution (BSI) coordinated the development of PAS 220:2008. The development of PAS 220:2008 was sponsored by the Confederation of the Food and Drink Industries of the European Union (CIAA) and the major food manufacturers, DANONE, Kraft, Nestlé and Unilever, contributed to the development of the Specification. Additionally, the PAS 220:2008 development Steering Group included representatives from the Food and Drink Federation (FDF), McDonald s, General Mills Europe (representing the FDF Food Hygiene Committee), the French National Association of Food Industries (representing CIAA) and certification bodies. In 2009, ISO fast-tracked PAS 220 to international status

26 26 ISO and TS ISO set out the principles of food safety management and HACCP, developed by Codex to identify, prevent and control food safety hazards There were several areas where the prerequisites did not meet all the requirements of the GFSI Guidance Document The CIAA (the Confederation of European Food and Drink Manufacturers) took on the challenge to bridge the gap by combining the standard with the prerequisite program PAS 220 released by BSI In 2009, ISO published ISO TS elevating PAS 220 to an international standard In 2012, BSI has withdrawn PAS 220 and FSSC will no longer be using it as a basis for certificates

27 FSSC Food Chain Categories C Processing 1 (Perishable animal products) including all activities after farming, e.g. slaughtering meat, poultry, eggs, dairy and fish products D Processing 2 (Perishable vegetal products) fresh fruits and fresh juices; preserved fruits; fresh vegetables; preserved vegetables E Processing 3 (Products with long shelf life at ambient temperature) canned products; biscuits; snacks; oil; drinking water; beverages; pasta; flour; sugar; salt L (Bio)chemical manufacturing additives; vitamins; pesticides; drugs; fertilizers; cleaning agents; biocultures M Packaging material manufacturing packaging material *these food chain categories have changed with the release of ISO 22003:2013

28 28 Elements of FSSC Certification Certification audits Stage 1 audits readiness evaluation Stage 2 audits facility assessment Audit length based on number of HACCP plans, number of production lines, number of employees, and presence of an existing Management System (eg. ISO 9001)

29 29 Elements of FSSC Certification Certification is good for 3 years, not 1 like other GFSI standards A surveillance audit must be conducted 12 months after the initial certification audit. A second surveillance is conducted in the following calendar year Surveillance audit length is less than initial audit time but based on the same factors for initial audit length

30 30 Certification Requirements Certification bodies operate in accordance with ISO and ISO Audits carried out in accordance with ISO auditing practices Audit day must see as many product lines being manufactured as possible All scheme requirements must be audited at every audit Detailed audit report issued with any nonconformities identified

31 31 FSSC Initial Certification Cycle GAP Analysis/ Pre-Assessment Stage 1 Audit Stage 2 Audit FSSC Certificate

32 32 FSSC Certification Cycle Stage 1 Audit Within 6 months Stage 2 Audit Within 12 months Surv. 1 Within next calendar year Surv. 2

33 FSSC Non-Conformities/Areas of Concern Area of Concern (AOC): assigned at the Stage 1 audit. Will identify an area of the system likely to become Non-conformance at Stage 2 Audit. Does not require closure to proceed. Opportunity for Improvement: assigned at Stage 1, Stage 2, surveillance, and recertification audits. Not considered a non-conformance, but a statement is made, which may identify areas for improvement however shall not make specific recommendation(s). This does not require closure to proceed. 33

34 FSSC Non-Conformities/Areas of Concern Minor Non Conformity assigned at Stage 2, surveillance, and recertification audits This is an area of the system for which the client is required to investigate potential non-conformity that does not effect the functioning of the system or the food safety of the product. This requires an action plan to be approved by the auditor for certification to proceed or be maintained. Major Non Conformity assigned at Stage 2, surveillance, and recertification audits Based on objective evidence, the absence of, or a significant failure to implement and/or maintain requirements of the applicable standard. Such issues may raise significant doubt as to the capability of the management system to achieve its intended outputs. This requires evidence of a corrective action, along with a root cause analysis, being implemented and functioning to proceed to certification or maintain certification. 34

35 FSSC Non-Conformities/Areas of Concern If during the next audit it is noted that an action plan for a Minor nonconformity from the previous audit does not resolve the non-conformance; the auditor will now raise the level of the non-conformity to MAJOR. Major non-conformances have to be closed within 90 days for those that are noted at a Stage 2 audit and 60 days for all other audits. In some cases an on site follow-up audit may be necessary to close nonconformances that cannot be completely verified by the auditor through . 35

36 FSSC Scoring & Rating There is no score with this audit There is no rating assigned; there is either a recommendation of maintain/grant certification or suspend/do not grant certification As with some non-conformance closure; a follow-up audit can be conducted so that certification can be granted for audits that are evaluated as being suspend/do not grant certification 36

37 Audit Checklist There is no set audit checklist for FSSC Checklists are created by the certification body but the evaluation must include all elements of ISO 22000, ISO/TS or PAS 223, and GFSI audit requirements An audit report is created at the completion of each audit which outlines the observations made during the evaluations 37

38 38 FSSC Audit Procedures Facility must be informed of auditor names prior to the audit Audits can be conducted in a team format Auditors shall be accompanied during all audits If a Stage 2 audit is not conducted within 6 months of the Stage 1 audit, the Stage 1 audit shall be repeated.

39 39 Auditor Training CB is responsible for auditor training and must justify to accreditation body Training requirements listed in ISO/TS Training elements Education post-secondary education Food safety training HACCP Pre-requisite programs Audit training Audit techniques based on ISO (ASQ) ISO standard Experience 5 years experience in food chain related industry At least 12 audit days of food safety management audits within last 3 years

40 40 Auditor Competency CB must make sure that auditor can demonstrate competency in the following areas: Audit principles Management systems Organizational situations Applicable regulations HACCP Pre-requisite programs Identification of food safety hazards Control measures

41 41 Benefits of ISO TS :2009 Food industry driven and developed and supported by key manufacturers and trade associations. Harmonizes prerequisite programs best practice for food manufacturing. Meets the PRP expectations and requirements of food manufacturing stakeholders, including food retailers and foodservice providers. Is fully auditable enabling organizations to demonstrate compliance with industry best practice. ISO/TS enhanced initiatives to harmonize global food safety standards.

42 42 Additional FSSC22000 Requirements FSSC Requirements Part 1 ISO/TS 22004:2005 provides guidance Definition of food safety Chain Approach Inventory of applicable regulations Specifications for services (Appendix 1A) Supervision of personnel in application of food safety principles (Appendix 1A)

43 43 What Comes Next? Apply For Certification Application Preliminary audit Certification audit Certification Surveillance (compliance) audits Triennial (recertification) audit Optional activities

44 44 Steps to Certification Application & Review Initial Certification Stage 1 Stage 2 Non Conformities Corrected Certification Surveillance Visit

45 How is FSSC different from other GFSI standards? 45

46 46 How is FSSC different from other GFSI standards? Scope of audit is system based, not product based Certification is for 3 years, not 1 year There are no critical findings in the audit There is no scoring or rating provided; you are either certified or not certified Corrective actions need only be confirmed for those deficiencies classified as MAJOR Audit duration for surveillance audits less than those for Stage 2 and recertification audits Program is ISO based and does not have scheme specific requirements that other programs have

47 SAI Global Assurance Services SAI Global was founded in Headquarters in Australia Listed at the ASX: SAI (around $1 Billion market cap) Largest registrar in North America, 14,000+ registrations / 40,000+ globally SAI Global acquired QMI in 2008 QMI founded in 1984 as North America s First Registrar 30 years in North America SAI Global acquired the Supply Chain Certification Services business from Steritech in 2013 Americas Offices in Cleveland, Toronto, Montreal, Mexico City and Sao Paulo. Regional representatives covering all North, Central and South Americas 500+ Auditors in North America 1,100 Globally Global Presence Diversified product sectors and customer base Accreditations: SCC, ANAB, EMA, UKAS, COFRAC, DAP, JAS-ANZ, IAOB, INN, ANSI, USDA, Customer survey results 94% satisfaction (Americas) SQF Certification Body of the year

48 Global Locations SAI Global Assurance Services Offices A U S T R A L I A B A N G L A D E S H B R A Z I L C A N A D A C H I N A C Z E C H E G Y P T F R A N C E G E O R G I A G E R M A N Y I N D I A I N D O N E S I A I R E L A N D I T A L Y J A P A N K O R E A L E B A N O N M E X I C O N E W Z E A L A N D P O L A N D R U S S I A S O U T H A F R I C A S P A I N S W E D E N T A I W A N T H A I L A N D T U N I S I E T U R K E Y U N I T E D K I N G D O M U N I T E D S T A T E S

49 Auditing, Certification, Training & Improvement Solutions FSSC 22000* BRC Food Safety* SQF* IFS* GLOBALG.A.P.* CanadaGAP* BRC Packaging* IFS PACsecure BRC Storage & Distribution Global Aquaculture Alliance BAP* (GAA) Aquaculture Stewardship Council (ASC) HACCP GMA-SAFE Gluten Free Certification Program Supply Chain Compliance Management Retail Audits Custom Programs ISO 9001 ISO OHSAS ISO *GFSI

50 Food Safety Services Training Public training (SQF, BRC, FS22k, HACCP, Internal Auditor, Food Defense) SQF, BRC, FS22k, HACCP, GMP, food safety training (on-site) Consulting On-site GAP analysis HACCP program facilitation Program review & development Allergen program review and validation Product specification building Audits GMP, DC, Animal Welfare, Packaging GFSI benchmarked certification audits

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53 Training & Improvement Solutions FSSC Classes: Feb 25 Calgary, AB Apr 16 Dallas, TX Apr 29 Toronto, ON Jun 3 Chicago, IL Food Defense for Manufacturers Introduction to Food Allergens Allergen Management for Food Manufacturers Traceability and Recall for Food Manufacturers Nonconformities and Root Cause Analysis for Food Safety Enhancing Management Representative Skills to Support Organizational Success SQF BRC Many more! 20% Discount! Code: FSSCWEB20* * Does not include elearning courses

54 Upcoming Food Safety Training Anaheim, CA Atlanta, GA Baltimore, MD Boston, MA Charlotte, NC Chicago, IL Dallas, TX Houston, TX Los Angeles, CA Nashville, TN Orlando, FL St. Louis, MO Calgary, AB Edmonton, AB Halifax, NS Montreal, QC Toronto, ON Ottawa, ON Vancouver, BC elearning: Introduction and Refresher to HACCP Food Safety Systems

55 Training & Improvement Solutions Consulting Services On-site GAP analysis HACCP program facilitation Program review & development Allergen program review and validation Product specification building

56 THANK YOU FOR ATTENDING

57 SAI Global Kris Middleton Technical Manager Agri Foods, SAI Global Assurance Services