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[[File:|right|400px]] Title: How can a LIMS help a food and beverage laboratory better handle incident management and corrective action?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: February 2024

Introduction

Numerous regulations, standards, and recommendations make clear that incident management and corrective action must be addressed by businesses in multiple industries. Examples include:

• 9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems61 FR 38806, 9 CFR Part 417.3
• 21 CFR Part 225 - Current Good Manufacturing Practice for Medicated Feeds 21 CFR Part 225.58 (d)21 CFR Part 225.158
• 42 CFR Part 493, Subpart K - Quality System for Nonwaived [Clinical] Testing 42 CFR Part 493.128242 CFR Part 493.1289
• A2LA C211 - Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation ProgramA2LA C211 4.8 and 4.11
• ASTM E1578-18 - Standard Guide for Laboratory InformaticsASTM E1578-18 E-9-5
• BRC Global Standard Food SafetyBRC GSFS, Issue 8, 3.4.3BRC GSFS, Issue 8, 5.6.1.2BRC GSFS, Issue 8, 9.3.5

CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
CJIS Security Policy 5.3.4
CJIS Security Policy Appendix G.7
E.U. Commission Directive 2003/94/EC Article 13
FDA Hazard Analysis Critical Control Point Principle 5
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22
NYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5, AU-6(1)
NIST 800-53, Rev. 5, IR-4(1) and IR-5
NIST 800-53, Rev. 5, SI-2 and SI-4
SQF FSC 9, Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3
WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
WHO Technical Report Series, #986, Annex 2, 5.0