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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

Blah blah

Numerous regulations, standards, recommendations, and guidelines make clear that incident management and corrective action must be addressed by businesses in multiple industries, not only within their workflows and processes but also within the information systems they use to better manage those workflows and processes. 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 493.1282 42 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, 3.4.3 BRC GSFS, Issue 8, 5.6.1.2 BRC GSFS, Issue 8, 9.3.5
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th EditionCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
E.U. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human useE.U. Commission Directive 2003/94/EC Article 13
FDA HACCP Principles & Application GuidelinesFDA Hazard Analysis Critical Control Point Principle 5
GFSI Benchmarking Requirements, Version 2020GFSI 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 GuidanceNYSDOH ELAP Medical Marijuana Microbiology Guidance
NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and OrganizationsNIST 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 Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food PackagingSQF 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 - WHO good manufacturing practices for pharmaceutical products: Main principlesWHO Technical Report Series, #986, Annex 2, 2.1 (f, j)WHO Technical Report Series, #986, Annex 2, 5.0

An incident is typically represented as a deviation from a standard operating procedure or standardized method that leads to a product outcome that is less than ideal, such as a substandard or injurious product before or after distribution, a low-quality or poor-tasting product that causes customer or consumer dissatisfaction, a product demonstrating regulatory non-compliance, or a product with generally perceived food safety issues.^[1]

As part of preventing incidents, the food and beverage manufacturer must not only ensure a well-designed and operational food safety system but also that it is able to monitor unsatisfactory or near-miss situations, analyze their trends and consequences, and investigate their root causes to better enable corrective and preventative action.^[1]

The areas where the laboratory has the greatest impact in identifying potential and real incidents is through regular and/or randomized testing to ensure HACCP critical limits aren't violated, as well as other varieties of verification testing (e.g., raw material monitoring, environmental monitoring, end-product quality control testing, or even investigation of employee-reported issues) at various points along the manufacturing process. This is usually done in-house or with a contracted third-party laboratory, but in the case of incident management where testing doubts arise, some other independent accredited laboratory may be needed to perform testing.^[1]