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Prinsip Mahir Sdn Bhd

HACCP MS-cGMP LEAD


ASSESSOR TRAINING
FOOD SAFETY
MANAGEMENT SYSTEM
(FSMS)

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training


CONTENT SECTION

BRIEF INTRODUCTION TO CONTEMPORARY FSMS 1

REQUIREMENTS OF HACCP MS – cGMP 21 CFR 110 2

ASSESSMENT, ASSESSOR, and PROGRAMMING ASSESSMENT 3

PLANNING THE HACCP MS AUDIT, THROUGH THE PROCESS 4

ASSESSMENT – AUDIT TECHNIQUES FOR HACCP 5

CONCLUSION & CLOSING THE HACCP MS ASSESSMENT- 6


AUDIT

CONSIDERATIONS TO REGULATIONS, LEGAL & OTHER 7


REQUIREMENTS

PROGRAM VENUE CLOSING DAY 5;


PRESENTATION BY TEAMS and FINAL TESTING 8

ACCREDITATION and CERTIFICATION PROTOCOLS 9

ANNEX

A. (1) BRS Glossary of Terms, (2) BRS HACCP MS SPECIFICATION


GUIDANCE DOCUMENT, (3) BRS HACCP ASSESSMENT CHECK
LIST
B. Case Studies – Workshop
C. Forms; Hand Outs in separate forms / documents: BRS Forms:
(Corrective) Action Request Form-008, Observation Form-018, FSMS
Audit Planning Form-007, Audit Plan Form-004, Opening Meeting
Form-014, Closing Meeting Form-017, List of Meeting participants
Form-005, Recommendation to Registration Form-010, and other forms
as provided by the instructors.

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training

Program Venue

Day Activity

1. Section 1 – Introduction to Contemporary FSMS; Initiate Section 2


HACCP MS and cGMP for Food Safety; and have participants
complete Test 01 (30 minutes)

2. Continue with Section 2 HACCP MS and cGMP for Food Safety; and
Workshop 1, [No test day], and continue with assigned workshop.

3. Section 3 – Assessment, Assessor, and Programming Assessments;


Section 4 Planning Assessments; and continue with Workshop 2 as it
relates to Planning and Plan of Assessment Audit, this is an
assignment to turn in by Friday (before closing); Have participants
complete Test 02 (45 minutes)

4. Section 5 Assessment Techniques; Section 6 Concluding and Closing


Assessments; Section 7 Considerations to Regulations and Other
Requirements; Section 8 Activates of Course for Day 5; and have
participants Test 03 (1-hour)

5. Section 10 Accreditation and Certification Protocols; Discussion of the


learning experience and a tem comprehensive 1.5-hour final test.

The intellectual rights, contents format and structure are property of BRS, as part of approved course for BRS recognized
organizations. The material herein, as previously indicates, are reserved to BRS and with the intent to Recognized
organizations to conduct approved and advanced courses. To communicate or contact BRS write specifically to BRS, Rim
of the World Office, PO Box 1020, 31977 Hilltop Boulevard, Suite D, Running Springs, California, USA 92382. RIMG
contains the course approval protocol, Requirements for Inclusion and Certification of BRS GlobalNet Professionals.
RIMG fulfills the requirements of ISO/IEC 17021, ISO 19011, ISO 9001:2000, and ISO/IEC 17024:2003 for the
certification of individuals within the BRS GlobalNet. As an IAF Signatory Multilateral Member, the Dutch Accreditation
Council annually BRS offices and filed attestation of assessments. No part of this document may be copy, reproduce,
transmit or retaining in e-media without objectively expressed by the international certification body BRS. Other
materials, herein expressed, contain herein are property of the International Organization for Standardization (ISO).

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training


Main References:

HACCP MS Requirements and Guidance to HACCP Management System


HACCP MS Auditing Guidance Checklist for HACCP MS Assessment – Audit that
is used as guidance to reporting
21CFR Part 110 Current Good Manufacturing Practices for the Food Sector
ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and beverage
industry
ISO 9000:2000 Quality management systems – fundamentals and vocabulary
ISO 9001:2000 Quality management systems requirements
ISO/IEC 17025:2005 General requirements for the competence of testing and calibrating laboratories
ISO 19011:2002 Guidelines for quality and/or environmental management system auditing
Terms & Definitions “Requirements for the Inclusion and Certification” addressing the
“RIMG” requirements of ISO 19011:2002 and ISO/IEC 17024:2003 for Certification of
Individuals.
ISO 22000:2005 Food safety management systems – Requirements for any organization in the
food chain.

Reference Others:

• Generality, “Sarbanese-Oxley”-Legal Act relating to Corporate Accountability.


• “HIPAA”-Health Insurance Accountability and Portability Act”
• Application of Multiple Site Assessments
• EU 178 – Traceability Requirements
• World Trade Organization – Restrictions and Barriers for Trade; NAFTA, Article 756
• Basell II – second of the basell accords that relates to banking supervision regarding international law

General Objectives of this course:

This course focuses on sharing with students and transferring instructor’s tacit knowledge as explicitly as
possible in pursue of an effective approach for assessment-auditing basic food safety management systems. The
primary objective of this training venue is to instruct QMS / FSMS assessment-auditors in the principles,
methods and practices to assessing for food safety with accepted international and national legal requirements,
and to validate competence through:

ƒ On-going daily assessment of participants, and


ƒ Written examination

Course Participants Pre Requirements

Experience, training and/or working knowledge of food safety or otherwise other risk relating management
environment such as ISO 9001, EMS 14001, EMAS (761), ISO 22000, ISO 15161, OSHMS (OHSAS 18001,
ILO-OSH), SA (Social Accountability).

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Attendees need be aware that BRS QMS program-venue requires evening work. This course is BRS approved
and authorized for recognized organizations to conduct. The instruction, course duration, examination, content,
competence of instructor and course administration needs to meet BRS Requirements for the Inclusion and
Certification of BRS GlobalNet Management System Professionals. Throughout the week a series of test will
occur and in day 5 there is a 1-hour comprehensive team written examination.

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training

INTRODUCTION OF DELEGATES

First – Complete short information questionnaire relating to professional and food safety matters

…your name?

What is your role within the employing organization?

How would you score your knowledge of food safety management systems or those quality
management systems and management within the risk disciplines, eg. HACCP, ISO 15161, ISO 2000,
ISO 9001, ISO 14001, OHSAS 18001, ILO-OSH, Basell II…? Loss Prevention (0-5)?

What are your objectives in taking this course?

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training

COURSE OBJECTIVES

ƒ Propitiate a forum leading to acquire extraordinary knowledge on HACCP MS – 21 CFR 110


requirements, while focusing on the food sector; this leads to gain knowledge on auditing to the
requirements HACCP MS, discussing contemporary assessment principles and concepts for
applying to internal or external assessments (1st, 2nd and 3rd Party);

o Discuss, participate and sharing experiences as to increasing knowledge in QMS for the
food and beverage sector issues, conducting assessment – audits while following the
protocol for planning, assessing, concluding and closing;

ƒ Assist in validation, verification and improving the objectives of organization through HACCP
and FSMS;

ƒ Discussions propitiating understanding of regulatory requirements within the scope of HACCP


MS;

ƒ This course fulfills the training requirements for inclusion into the BRS GlobalNet;

o To meet the training requirement for qualifying and certifying HACCP under BRS
International Registration Body or other certification bodies or registrars accepting BRS
training venue to fulfill certification requirements…and….

ƒ …Assist in providing CPD (continual education development) requirements to qualify


participants toward HACCP or FSMS auditor within the food and beverage sector.

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training

Comprehensive protocol to approve the lead assessor – auditor course (transition or internal auditor):

1. Class participation…

2. Assessment planning and plan, individually…

3. Workshops…

4. Conclusion and presenting, individually…

5. Combined tests 3 + final, tests are taken in teams (as are not memorizing exercises)

Successfully meeting the 5-day course requirements, the minimum combine score is 70%. The written
test has 40% weigh of the score and workshops carry 60% weigh.

If you need to re-test: Re-sitting requires coordinating with closest BRS GlobalNet
Recognized Organization or Professional, and a fee payable prior to re sitting the test.
The cost of re sitting is determined by the recognized organization.

BRS is an accredited international registration body in agreement with Raad voor Accreditatie, which
includes multilateral agreement with IAF accreditation bodies. BRS management operations include
certification of individuals as required by requirements in “RIMG” Requirements for the Inclkusion
and Certification of BRS GlobalNet Professionals aligned in accordance with ISO/IEC 17024. “RIMG”
addresses the requirements of ISO 19011:2002 and ISO/IEC 17024:2003. As an accredited registration
body in agreement with RvA BRS opts to meet ISO/IEC 17024:2003 for the exclusive certification of
BRS GlobalNet Professionals as well open to public.

This course meets the requirements for training for the BRS “RIMG” scheme: other requirements are
equivalent to accreditation and registration bodies and include:

1. Training
2. Professional Experience
3. Education
4. Assessment Experiences (2nd and 3rd Party only)
5. [Endorsement from professionals within the field (or BRS)]

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Prinsip Mahir Sdn Bhd

HACCP cGMP Lead Assessor Training

Re-sitting the test – For participants not achieving 70% +score with the written test, you may request
taking a second course within 6 months. The cost of re sitting is decided by each “Recognized
Organization”.

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