FDA Inspections are Different from ISO Audits, So Don't Treat Them the Same - OMTEC 2017
3 rd Party Audits and Regulatory Inspections Food Industry Perspective
-
Upload
connor-black -
Category
Documents
-
view
34 -
download
0
description
Transcript of 3 rd Party Audits and Regulatory Inspections Food Industry Perspective
![Page 1: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/1.jpg)
1
3rd Party Audits and Regulatory Inspections
Food Industry Perspective
Tim Ahn Mars ChocolateGlobal Director - Quality & Food Safety
![Page 2: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/2.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
Agenda
2
• Introduction to Mars, Incorporated • Overview of regulatory inspections
• Overview of 3rd party audits
• Using 3rd party audits to drive Quality & Food Safety Management System effectiveness.
![Page 3: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/3.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only3
![Page 4: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/4.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only4
![Page 5: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/5.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only5
![Page 6: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/6.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
Regulatory Inspections
6
• Regulatory inspections are key part of national and local food law enforcement framework.
• Important role in assuring compliance with regulations regarding:• public health & safety• food quality • labelling
• Inspections are government funded.
• Important tool in assuring retail food establishments
• Focused on basics – GMP/GHP.
![Page 7: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/7.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
Regulatory Inspections
7
• Inspections are usually unannounced. Frequency can vary. Can be routine or “for cause”.
• Inspections are not audits Designed to identify issues and non-complaint processors.
• Inspector training can vary by country and local jurisdictions. • Regulatory inspections collect evidence - need to be treated as
legal proceedings. Can result in publicity, warning letters, recall, fines, etc...
• Depending on country and laws, processors need to be aware of their legal rights. Processors need to prepare in advance for expected inspections.
![Page 8: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/8.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
3rd Party Audits
8
• Audit - Planned, independent, and documented examination and verification of activities, records, processes, and other elements of a quality system to determine their conformity with the requirements of a quality standard.
• Different types of standards• International standards – ISO 9000, ISO 22000• Global Food Safety Initiative (GFSI) audit schemes• Other GMP/GHP, HACCP standards
• Quality Management System & Food Safety Management System audit• Management review • Internal audit • Corrective action
![Page 9: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/9.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
3rd Party Audits
9
• Processor pays cost of audit.
• Certification demonstrates food safety compliance.
• Standardize auditor training and certification.
• Standards and certifications • International recognition• GFSI accepted by major retailers• May be required in certain situations
![Page 10: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/10.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
3rd Party Audits & Effective Q&FS Programs
10
• Quality and Food Safety Management Systems provide structure from which to produce safe, wholesome, and legal foods.
• Meet regulatory requirements
• Achieve required customer certifications
• Drive continuous improvement activities
• Demonstrate organizational governance
• 3rd party audits provide independent verification of Q&FS Management Systems implementation and effectiveness.
•
![Page 11: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/11.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only
3rd Party Audits & Effective Q&FS Programs
11
• Customized 3rd party assurance can be used to assess implementation and effectiveness of company specific standards and processes.
• Mars Incorporated has partnered with LRQA to develop a customized program of comprehensive site audits.
• Mars specific standards implementation• International standards certification• Corporate Q&FS reporting and metrics• Enable corporate Q&FS governance
![Page 12: 3 rd Party Audits and Regulatory Inspections Food Industry Perspective](https://reader036.fdocuments.in/reader036/viewer/2022062517/5681362b550346895d9da5d7/html5/thumbnails/12.jpg)
Privileged and Confidential - for Mars Internal Use onlyPrivileged and Confidential - for Mars Internal Use only12
THANK YOU