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Iowa Grain Quality Initiative

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FDA Bioterror Act. FC Mock Recall Results. Farmers Cooperative Company. Northwest Iowa Company ... FDA guidelines for traceability under the Bioterrorism Act? ... – PowerPoint PPT presentation

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Title: Iowa Grain Quality Initiative


1
The Impact of an Auditable Quality Management
System in a Grain Elevator Application
  • Iowa Grain Quality Initiative
  • Advisory Committee Meeting 1/12/07
  • Chad Laux
  • Industrial and Agricultural Technology Program
  • Dr. Charles Hurburgh, Jr. Major Professor

2
Outline
  • Farmers Cooperative
  • Results of QMS in Quality Control
  • FDA Bioterror Act
  • FC Mock Recall Results

3
Farmers Cooperative Company
  • Northwest Iowa Company
  • Over 400 million in sales
  • 50 locations and growing
  • 350 employees
  • Departments Grain, Agronomy, Feed, Seed, Admin.,
    Accounting

Source FC, 2006
4
Problem Statement
  • With the adoption of QMS, how has it impacted
    Farmers Cooperative operations?
  • What measurements would provide evidence so FC
    may proceed with other location implementations?
  • Inquiry focused on company processes which
    directly affect grain preservation and handling

5
Core processes and ISO 9000
Source ISO, 2000
6
Core Farmers Cooperative Co. Processes ISO
Defined
  • Processes which transform the end product in ISO
    structure

7
Statistical Process Control - Grain Grading
  • Farmers Coop has been grading the same grain
    samples that were also graded by an official
    inspector
  • Matching the precision of the official inspectors

8
Research Model Hypothesis
  • Grain quality for shipment is improved when QMS
    procedures are adopted
  • FC/FGIS/customer comparisons of same sample
  • Corn Moisture - Content Instrument Factor
  • Corn Damage - Visual Judgment Factor
  • Smaller Difference is Better!
  • Comparison of
  • QMS locations vs. non-QMS locations
  • Locations before and after QMS implementation

9
Moisture Content Absolute Mean Difference
  • All Locations

w/ SEMs shown
n15087
n279
n218
10
Moisture Content Absolute Mean Difference
Location 1
  • Before and After AIB/QSE Adoption

w/ SEMs shown
n218
n2924
11
Moisture Content Absolute Mean Difference
Location 2
  • Before and After QMS Adoption

w/ SEMs shown
N279
N2864
12
Total Points Damage Absolute Mean Difference
  • All Locations

w/ SEMs shown
n79
n110
n5303
13
Total Points Damage Absolute Mean Difference
Location 1
  • Before and After AIB/QSE Adoption

w/ SEMs shown
n79
n1197
14
Total Points Damage Absolute Mean Difference
Location 2
  • Before and After QMS Adoption

w/ SEMs shown
n110
n1637
15
Conclusions
  • QMS positively impacted FC operations through
    improved product quality of shipped grain.
  • Better resource management gt Better quality
    control
  • There was no difference in quality where the
    basis of determination was instrumentation.
    (moisture content)
  • Process control through calibration
  • BPM is a suitable model of inquiry for research
    of ISO results in organizations

16
How to Meet the FDA Bioterrorism Act An Elevator
Case Study of Tracking Commodity Grain Using ISO
9000
17
Bioterrorism Act of 2002
  • FDA Mandate of one up-one down traceability by
    6/06 (sliding scale based on size)
  • Protection of food supply
  • Legislation
  • Registration Section 305
  • Recordkeeping maintenance Title III, Section
    306
  • FDA expects documentation to be mode of
    traceability
  • Produce information upon official investigation
  • Unfunded mandate
  • Note Traceability a requirement of ISO
    certification

18
Product Traceability
  • Research Questions Does a QMS facilitate
    traceability in commodity grain elevator
    operations?
  • Does the traceability system meet FDA guidelines
    for traceability under the Bioterrorism Act?

19
Methodology
  • Traceability/safety training conducted at 21
    QMS/non-QMS locations
  • Mock recalls conducted at locations to measure of
    training effectiveness (ISO requirement)
  • Devin Mogler (QMS Intern) conducted recalls per
    FC ISO Procedure for Recalling Commodity Grain

20
Recall Summary Results
21
Distribution of Recall Duration
22
Discussion and Conclusions
  • Audited FC results per FDA rules
  • QMS traceability is adequate to meet FDA mandate
  • Wide variation in duration of recalls
  • Wide variation in precision i.e. lot size

23
Recommendations
  • Trace from back to front in next round of recalls
  • Follow through on multi-site recalls
  • Improve internal communication reduce lag time
  • Use older scale tickets in recalls will test
    system more thoroughly
  • Collect all sources in bin, railcar assignments
    indicator of precision (index)
  • Use controlled documents for recalls
    traceable documents required
  • Launch CARs on failed recalls close the loop
  • Decide on lot sizes operations issue

24
Final Steps
  • Impact of ISO on Quality and Quantity (Inventory
    mgmt.) on grain
  • Key process with management measures on
    performance imbedded in QMS system
  • 8.2.4 Monitoring and measurement of product
  • 8.3 Control of non-conforming product
  • 8.5.2 Corrective and preventive action
  • Final Defense and graduate by Aug. 2007
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