Product Contamination & Recall Assessment

Assessment Introduction

    Page 1

    Welcome to the Product Contamination & Recall IQRM!

    Product Contamination and Product Recalls have become a pervasive problem. Whether the result of accidental contamination, manufacturing error, intentional criminal acts, vindictive employees or simple human error, organizations that fall victim to these incidents incur staggering costs- not only in damage control but also in restoring their lost profits, reputation, customer relationships, brand name and market share.

    Today, we are in the middle of a regulatory alphabet soup- USDA, FDA, FSMA OF 2012 (Food Safety Modernization Act), CDC (Center for Disease Control), CPSC (Consumer Product Safety Commission), and NHTSA (National Highway Traffic Safety Administration). The increased testing coupled with a zero tolerance for manufacturing errors, contamination and the regulatory tug of war currently under way have lead to a significant increase in the amount of product recalls. If your firm is producing, distributing or wholesaling any type of edible or durable goods product, you have a potential exposure.

    Please click below to begin a 16 statement survey to gain your organization’s IQRM Effectiveness Risk Audit Score as relates to product contamination and recall.  

    Question 1

    How effective is your organization with regards to educating senior management on relevant product recall risks and the level of commitment needed to address them?

    Question 2

    How effective is person(s) assigned the responsibility for the overall product quality and safety at implementing overall product recall risk management?

    Question 3

    How would you rank the quality control procedures and policies that your organization currently has in place? 

    Question 4

    How effective are your basic production protocols with regards to the testing of incoming raw materials, in line end line product testing, product quarantine, batch coding systems and test and hold system?

    Question 5

    How effectively does your organization use additional industry-specific innovative technologies for the purpose of pathogen/product defect reduction?

    Question 6

    How effective is your organization at ensuring there is a supplier/vendor, co-packer verification program which includes certificates of insurance, testing of materials, risk transfer contracts, and/or third-party audits?

    Question 7

    How effective is your organization’s traceability system with regards to utilizing a coding system, and forward and backwards traceability?

    Question 8

    How effective is your organization at submitting to and scoring 90% or better on independent third-party quality control audits?

    Question 9

    How effective is your organization at maintaining an active crisis response team and a product recall procedures manual?

    Question 10

    How effective is your organization in training employees to understand their critical responsibilities in the production of a safe product along with the roles they need to assume in the event of a product recall?

    Question 11

    To what degree does your organization perform mock recalls;  analyze and evaluate the results; and use the analysis after an actual product recall/product defect event? 

    Question 12

    How effective is your organization in retaining a team of outside experts who can be called on as a resource to deal with a potential product recall?

    Question 13

    How effective is are your quality control protocols at ensuring all labels meet regulatory requirements and are checked for accuracy?

    Question 14

    To what degree is your organization made aware of and in full compliance with all relevant industry standards and governmental regulations?

    Question 15

    To what degree has your organization examined product recall insurance and purchased coverage when the cost has justified the benefits?

    Question 16

    How effectively does your organization handle employee layoffs, job reassignments, plant shut downs and union contract negotiations so that employee negativity is minimized?

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