FOOD SAFETY. Certification Process, Audit and Certification. 30 January 2018 Radziah Mohd Daud SIRIM QAS International

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1 FOOD SAFETY Certification Process, Audit and Certification 30 January 2018 Radziah Mohd Daud SIRIM QAS International

2 TOPICS Food safety standards Certification process Auditing and challenges Benefits of certification Brief changes in ISO :2018

3 About SIRIM QAS INTERNATIONAL Established in 1996 as a wholly-owned subsidiary of SIRIM Berhad Have been providing conformity assessment services since the 1970s when these services were provided as a division of SIRIM Berhad. Staff strength: 600 No. of certifications issued: more than 9,000 Malaysian based Local and international clients in countries such as Thailand, Singapore, Brunei, Indonesia, Vietnam, Myanmar, Korea, Philippines, China, Taiwan, Japan, India, Sri Lanka, Australia, New Zealand, Germany and Spain, Finland, Holland

4 ACCREDITATION (related to Food Safety Management System Certification)

5 Accreditations by STANDARDS MALAYSIA Management System Certification (MS ISO 9001, MS ISO 14001, OHSAS 18001, MS 1722: Part 1, HACCP, Food Safety Management System, GMP, Forest Management Certification), Product Certification Chain-of-Custody for wood-based products Type Approval

6 Accreditations by STANDARDS MALAYSIA Management System Certification (MS ISO 9001, MS ISO 14001, OHSAS 18001, MS 1722: Part 1, HACCP, Food Safety Management System, GMP, Forest Management Certification), Product Certification Chain-of-Custody for wood-based products Type Approval

7 Partnership in IQNet This means all 30 Certification Bodies IQNet partners including SIRIM QAS International mutually recognise the certificates as being equivalent to their own. Regular and rigorous peer evaluations across the Network is conducted to ensure confidence in this mutual recognition

8 What is IQNet? IQNet is an international certification entity, formed by more than 30 of the most relevant certification entities of the most important countries. Some certification entities involved in IQNet are the following: AENOR (Spain), AFNOR (France), AIB (Belgium), ANCE, IMNC (Mexico), APCER (Portugal), CCC, CSIQ (Italy), CQC (China), CQS (Czech Republic), Cro Cert (Crocacia), DQS (Germany), DS (Denmark), ELOT (Greece), FCAV (Brazil), FONDONORMA (Venezuela), HKQAA (Hong Kong), ICONTEC (Colombia), Inspecta (Finland), IRAM (Argentina), JQA (Japan), KFQ (Korea), MSZT (Hungary), Nemko AS (Norway), NSAI (Ireland), PCBC (Poland), Quality Austria (Austria), RR (Russia), SIQ (Slovenia), SQS (Switzerland), SRAC (Romania), TSE (Turkey), YUQS (Serbia), AFNOR, ICCS, DQS, NSAI (USA), etc..

9 IQNet Partner List

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11 The purpose of the IQNet certificates The IQNet certificates are used by companies and organizations worldwide to testify that they are certified in a particular standard (as ISO 9001, ISO14001, ISO or any other).

12 The IQ Net seal The IQNet Certified Management System seal is a logo which the certified companies usually add with the stamp of their local certification entity. The IQ Net seal These logos are accompanied with the codes of the standards that they have certified

13 The most common certified standards are the next ones: ISO 9001 (Quality), ISO / EMAS (Environment), OHSAS (Risk Prevention), ISO / FSSC / BRC / IFS (Food Security), SA8000 / BSCI / IQNet SR 10 ( Sustainability and Corporate Social Responsibility), ISO (Information technology ), BBP / IBEC (Business Excellence), ISO 22301, ISO / TS (Automotive Industry), IRIS, TL 9000, ISO and other international standards.

14 Benefits for organisation IQNet services provide an international passport to global recognition and worldwide market access. The IQNet approach simplifies International certification process and reduces associated costs.

15 IQNet - Leader in global certification services IQNet, through its international network, is the preferred provider for global certification services and assessments, with a focus on management systems: with global resources and capabilities leading in integrity and competency: accredited by more than 40 accreditation bodies serving in all business and social sectors offering to customers a large variety of innovative, value adding services

16 IQNet Certificate All IQNet members have signed the IQNet Multi-Lateral Agreement (MLA). This means they mutually recognise the ISO 9001, ISO and various other certificates of all other IQNet partner as being equivalent to their own. IQNet Certificates are the main evidence of this international recognition. They are provided by all IQNet certification bodies to their respective customers. Confidence in certificate equivalence is founded on regular and rigorous peer evaluations across the Network.

17 SIRIM QAS INTERNATIONAL SCOPE OF SERVICES RELATED TO FOOD & BEVERAGE

18 FOOD AND BEVERAGE Concerns : Quality and safety of the food served to customers. Food safety must be taken into high consideration as this relates to the health and well being of the customers Premises where the food is prepared, cooked, served complies with relevant regulations applicable to food Food prepared, cooked, served meets customers expectations in terms of quality and safety Need to obtain customers confidence in the safety and quality of food served

19 Quality aspects visual - Properly cooked - uniform colour - juicy - meeting customer s expectation - tasty Food Safety aspects GMP aspects - Have the cooking utensils been washed and rinsed to be thoroughly free from sanitisers? - Have all the hazards (biological, chemical and physical ) been prevented, eliminated or reduced to acceptable levels? - Are the premises and work surfaces clean? - Do production personnel follow hygiene rules? - Are the premises free from pest? - Are equipment suitable and safe for processing food? - Are facilties adequate and safe including water, ice and steam? - Have the frozen chicken been thawed in a chiller? - Have all the significant hazards been processed out? - Are there contaminants from seasonings used onto the chicken? - Adequate cooking temperature & time to kill the food poisoning bacteria? - Antibiotics content in the chicken been checked?

20 STANDARDS ON FOOD SAFETY

21 Good Manufacturing Practice (GMP) Hazard Analysis and Critical Control Point (HACCP) Food Safety Management System (FSMS) Coverage of each system? Differences? Similarities? Can comply to one(1) system and comply to the rest? Can a single audit cover 3 systems? Can three (3) certificates be issued with a single audit? Compatibility with other management system standard?

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23 Pre Requisite Programmes Manage basic conditions and activities of food premises Not selected for the purpose of controlling specific identified hazards but for maintaining a hygienic production, process and/or handling

24 Water Packaging Personnel hygiene Recall Documentation & records) Training Incoming material Facilities Waste mgt Equipment Pest control Premises Maintenance & cleaning Location Handling, storage & transportation Cleaning & personnel hygiene Cleaning

25 PREREQUISITE PROGRAMMES MS 1480:2007(HACCP) MS 1514 : 2009 Good Manufacturing Practices (First revision)

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27 Scope describes the requirements for food safety according to HACCP system to ensure the safety of foodstuffs during preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply in any sector of the food chain.

28 Scope - GMP & HACCP Applicable to food processing only Does not cover upstream (farms), food packaging material etc Not readily compatible with other standards e.g, ISO 9001, Internal audit and management review separate but can integrate into one Documentation of the two (2) systems are different

29 HACCP PRE REQUISITE PROGRAMMES (GMP)

30 7 Principles of HACCP Principle 1 Principle 2 Principle 3 Principle 4 Principle 5 Principle 6 Principle 7 Conduct a Hazard Analysis Identify Critical Control Points Establish Critical Limit Establish Monitoring Procedures Establish Corrective Action Procedures Verification Record Keeping

31 Identify & evaluate hazards In RM and processs P 1 P 1 P 1 P 4 Monitor temp 1 H + 3 W P 5 Take corrective action if temp is deviated Control Critical Limit eg eg 90ºC Verification of corrective action P 3 P 6 P 7 P 2 Identify CCP step eg frying Document and recording

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33 ISO HACCP MS 1480 SAFE FOOD Pre requisite GMP MS 1514 Pre requisite (GMP)

34 Additional elements in ISO SAFE FOOD Pre requisite (GMP) Laboratory facilities Boiler chemicals Compressed air and other gases corrective maintenance Selection and management of suppliers Allergen management Cleaning in place (CIP) systems Staff canteens and designated eating areas Rework Warehousing Food defence, biovigilance, and bioterrorism

35 Scope All requirements are generic and are intended to be applicable to all organisations in the food chain, regardless of type, size and complexity. This includes organizations directly or indirectly involved in one or more steps of the food chain The standard allows small and/or less developed organization to implement an externally developed combination of control measures

36 Statutory and regulatory authorities Scope FSMS Crop Producers Producers of pesticides, fertilizer and veterinary drugs Feed producers Primary food producers Food manufacturers Secondary food manufacturers Wholesalers Retailers, food service operators and caterers Food chain for the production of ingredients and additives. Transport and storage operators Producers of equipment Producers of cleaning and sanitizing agents Producers of packaging materials Service providers Consumers

37 Key elements ISO Interactive communication Management system Pre requisite programmes HACCP principles Control food hazards

38 PREREQUISITE PROGRAMMES ISO :2005 (FOOD SAFETY MANAGEMENT SYSTEM) ISO/TS :2009 ISO/TS :2013 ISO/TS :2011 ISO/TS : 2013 Part 1: Food Manufacturing Part 2 : Catering Part 3 : Farming Part 4 ; Food Packaging Materials

39 FSMS Process model

40 Food safety planning-types 1. Recipe Based Food Safety Plans or 2. Flowchart Based Food Safety Plans

41 Food safety planning-types 3. Process Based Food Safety Plans -involves grouping together menu items that are processed in the same way eg. No Cook - Serve Cook Serve Cook Chill Serve Cook Chill Reheat Serve salads, sandwiches curry, laksa, fried rice potato salad, kerabu soups, pasta sauce, gravy

42 SIRIM QAS INTERNATIONAL CERTIFICATION SERVICES RELATED TO FOOD SAFETY

43 CERTIFICATION PROCESSES OF GMP, HACCP, FSMS APPLICATION STAGE 1 (DOCUMENTATION ) STAGE 2 (COMPLIANCE ) RECOMMENDATION AWARD OF CERTIFICATE SURVEILLANCE

44 DETAILS OF CERTIFICATION PROCESS Questionnaire questionnaires will be given to applicant Quotation quotation will be issued after submission of questionnaire by applicant Application applicant submits application

45 DETAILS OF CERTIFICATION PROCESS Stage 1 Audit team will conduct a Stage 1 audit on site focusing on documentation GMP, HACCP and FSMS System Stage 2 Stage 2 audit will be conducted by audit team upon applicant s readiness to verify effective implementation of GMP, HACCP and FSMS systems

46 DETAILS OF CERTIFICATION PROCESS CERTIFICATION Upon closing of all non conformities, a recommendation report will be submitted to the Certification Panel for approval prior to issuance of certificates SURVEILLANCE AUDIT/ RECERTIFICATION Annual surveillance audit will be carried out to assess maintenance of the GMP, HACCP and FSMS systems annually and a full system audit will be carried out once in every 3 years.

47 COLLABORATION WITH MINISTRY OF HEALTH MALAYSIA ON HACCP CERTIFICATION

48 COLLABORATION DETAILS SIRIM QAS INT. will: Handle application Conduct stages 1 & 2 audits Effectively verify and resolve all non conformities raised Recommend to the Certification Panel of SIRIM QAS International AND to the Approval Panel of Ministry of Health Malaysia Conduct annual surveillance. Reports are given to Ministry of Health for review

49 QUESTIONNAIRE APPLICATION SIRIM RECOMMENDATION FOR HACCP CERTIFICATION STAGE 1 AUDIT STAGE 2 AUDIT ISSUANCE OF CERTIFICATE ISSUANCE OF CERTIFICATE 3 Years validity 3 Years validity ANNUAL SURVEILLANCE ISSUES OF CONCERN NON CONFORMITIES MIN. OF HEALTH RECOMMENDATION FOR HACCP CERTIFICATION

50 ANNUAL SURVEILLANCE - COLLABORATION IN HACCP CERTIFICATION MOH will conduct one (1) surveillance audit together with SIRIM QAS International SIRIM QAS International will conduct surveillance in the 2 nd and 3 rd year of certification

51 Integrating MS 1480: 2007 (HACCP) with ISO 22000:2005

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53 ISO Auditing Challenges

54 7 Principles of HACCP Principle 1 Principle 2 Principle 3 Principle 4 Principle 5 Principle 6 Principle 7 Conduct a Hazard Analysis Identify Critical Control Points Establish Critical Limit Establish Monitoring Procedures Establish Corrective Action Procedures Verification Record Keeping

55 Principle 4 Monitoring

56 7 Principles of HACCP Principle 1 Principle 2 Principle 3 Principle 4 Principle 5 Principle 6 Principle 7 Conduct a Hazard Analysis Identify Critical Control Points Establish Critical Limit Establish Monitoring Procedures Establish Corrective Action Procedures Verification Record Keeping

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58 7 Principles of HACCP Principle 1 Principle 2 Principle 3 Principle 4 Principle 5 Principle 6 Principle 7 Conduct a Hazard Analysis Identify Critical Control Points Establish Critical Limit Establish Monitoring Procedures Establish Corrective Action Procedures Verification Record Keeping

59 Principle 7 Documentation and record keeping Control of documents and records

60 Challenges Lack of understanding on food safety systems Lack of technical expertise and human resource Weak or poor Infrastructure especially in kitchens Food workers lack interest and have a negative attitude toward food safety programs Time and effort to develop and implement HACCP /ISO Excessive volume of Paperwork - inconsistent monitoring of CCPs

61 Benefits of Food Safety Systems implementation

62 Benefits: Include: - Resource optimization - internally and along the food chain More efficient and dynamic food safety hazard control All control measures subjected to hazard analysis Better planning, less post process verification Improved documentation.

63 Benefits (continued): Saves resources by reducing overlapping system audits - HOW? Systematic management of prerequisite programmes Control focused on what is necessary Widely applicable because it is focused on end results Organized and targeted communication among trade partners (repeated below) Valid basis for taking decisions Increased due diligence Dynamic communication on food safety issues with suppliers, customers, regulators and other interested parties

64 CERTIFICATIONS OF FSMS, HACCP AND GMP AND RELATED ISSUES

65 Questions Can comply to one(1) system and comply to the rest? Can a single audit cover 3 systems? Can three (3) certificates be issued with a single audit? Answers Yes. Implementing ISO can also ensure the compliance to GMP and HACCP Yes. Auditing to ISO can cover the GMP and HACCP auditing Yes. The expiry dates are also Aligned Compatibility with other management system standard? Yes, with other management system standard e.g. ISO 9001*

66 ISO 22000: 2005 undergoing revision since 2014 revision undertaken by ISO/TC 34/SC 17/W8 currently, still in draft form ISO FDIS ( Final Draft International Standard) expected to be published by June 2018 IAF will issue communique on transition timelines from 2005 to 2018 version

67 FDIS ISO :2018 update old and introduce new terms and definitions; Forty-five (45) definitions are now listed in the FDIS version clarify to the end users, the differences of Pre-requisite Programs (PRPs), Operational Prerequisite Programs (OPRPs) and Critical Control Points (CCPs) provide a clear understanding of the risk based approach adopt the new High Level Structure (HLS) developed and used by ISO to allow an easier implementation of an Integrated Management System align with recent developments and concepts in food safety standards and Codex Alimentarius

68 Timelines of ISO 22000:2018 Proposal Stage Preparatory Stage Committee Stage (CD) Enquiry stage (DIS) Finalising (FDIS) Approval Stage Expected publication Nov 2014 Nov 2015 Dec 2016 Jul 2017 Oct 2017 June 2018

69 FDIS 22000:2018 ISO 22000:2005 : 1.Scope 2.Normative References 3.Terms and Definitions 4.Context of the organization 5.Leadership 6.Planning 7.Support STRUCTURE 1. Scope 2. Normative References 3. Terms and definitions 4. FSMS 5. Management responsibility 6. Resource management 8.Operation 9.Performance evaluation of the food safety management system 7. Planning and realization of safe products 8. Validation, verification and improvement of the FSMS 10.Improvement

70 Major changes Clarification on how the Plan-Do-Check-Act (PDCA) cycle works by including two separate PDCA cycles in the standard, that operate one inside the other. The first PDCA apply to the management system while the second PDCA addresses the operations covering the HACCP principles

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72 CONCEPT OF ISO DIS ORGANIZATION LEVEL Identify external and internal issues + Determine the interested parties and their requirements Define the scope of the FSMS of the company Determine risks & opportunities + Actions taken to address the risks and opportunities (if possible) OPERATION LEVEL FSMS Planning, Implementation, Monitoring and Verification

73 EXTERNAL & INTERNAL ISSUES ISSUES EXTERNAL INTERNAL POLITICAL ECONOMY SOCIAL TECHNOLOGY ENVIRONMENT LEGAL

74 INTERESTED PARTIES INTERESTED PARTIES NEEDS & EXPECTATION (REQUIREMENTS) CUSTOMER REGULATOR SUPPLIER EMPLOYEES STAKEHOLDER

75 Thank you SIRIM QAS International Sdn. Bhd