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
Outline
Farmer’s Cooperative
 Results of QMS in Quality Control
 FDA Bioterror Act
 FC Mock Recall Results

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
Problem Statement



With the adoption of QMS, how has it
impacted Farmer’s 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
Core Farmer’s Cooperative Co.
Processes: ISO Defined

Processes which transform the end product in ISO
structure
7.2.1 Order Processing for Gain Shipments
Shipping
7.4.3 Verification of Purchased Product
Receiving
7.5.1 Control of Operations-Loading Order
Shipping
7.5.1 Control of Operations-Release & Post Shipping
Shipping
7.5.3 Identification and Tracking- Grain Identification and Tracking All 3
7.5.3 Identification and Tracking-Inspection and Grading
Storage
7.5.5 Preservation of Grain-Handling and Preservation
Storage
7.5.5 Preservation of Grain-Storage Areas
Storage
7.5.5 Preservation of Grain-Bulk Grain Shipping
Storage
8.2.4 In-process Inspections
Storage
8.2.5 Final Inspection
Storage
8.3.1 Control of Nonconforming Grain
Shipping
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
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
Moisture Content Absolute Mean
Difference
All Locations
0.5
FC-Official (% pts)
0.4
0.3
0.2
0.1
0.0
w/ SEM’s shown
AIB
ISO
None
n=218
n=279
n=15087
Moisture Content Absolute Mean
Difference – Location 1
Before and After AIB/QSE Adoption
0.5
FC-Official (% pts)
0.4
0.3
0.2
0.1
0.0
w/ SEM’s shown
After QSE
n=218
Before QSE
n=2924
Moisture Content Absolute Mean
Difference – Location 2
Before and After QMS Adoption
0.5
FC-Official (% pts)
0.4
0.3
0.2
0.1
0.0
w/ SEM’s shown
After
N=279
Before QMS
N=2864
Total Points % Damage Absolute Mean
Difference
All Locations
5
FC-Official (% pts)
4
3
2
1
0
w/ SEM’s shown
AIB
ISO
n=79
n=110
None
n=5303
Total Points % Damage Absolute Mean
Difference– Location 1
Before and After AIB/QSE Adoption
5
FC-Official (% pts)
4
3
2
1
0
w/ SEM’s shown
After QSE
n=79
Before QSE
n=1197
Total Points % Damage Absolute Mean
Difference – Location 2
Before and After QMS Adoption
10
FC-Official (% pts)
8
6
4
2
0
w/ SEM’s shown
After
Before QMS
n=110
n=1637
Conclusions

QMS positively impacted FC operations
through improved product quality of shipped
grain.
– Better resource management => 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
How to Meet the FDA Bioterrorism Act:
An Elevator Case Study of Tracking
Commodity Grain Using ISO 9000
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

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?

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

Recall Summary Results
Location
Commodity Quantity (bu)
Received
Source
Lot/code identifier
Recipient
Lot/code identifier
Delivered
Recall Time (hrs.)
Location 1
Corn
282.14
6/19/2006
Producer
1 scale ticket
External railroad
1 load order
6/30/2006
1.77
Location 2
Soybeans
284.00
6/23/2006
Producer
1 scale ticket
To FC location 10
3 scale tickets
6/23/2006
3.07
Location 3
Corn
998.93
6/15/2006
Producer
1 scale ticket
Still in storage
1 storage bin
n/a
24.42
Location 4
Soybeans
282.67
6/16/2006
Producer
1 scale ticket
Still in storage
1 storage bin
n/a
1.95
Location 5
Corn
442.86
6/12/2006
Producer
1 scale ticket
Still in storage
1 storage bin
n/a
20.88
Location 6
Soybeans
199.00
6/26/2006
Producer
1 scale ticket
To FC location 8
14 scale tickets
7/5/2006
Location 7
Corn
762.50
6/14/2006
Producer
1 scale ticket
Still in storage
3 storage bins
n/a
22.17
Location 8
Soybeans
12,070.00
7/5/2006
From FC location 6
14 scale tickets
External railroad
1 load order
7/5/2006
17.25
Location 9
Soybeans
2,704.00
6/23/2006
From FC location 2
3 scale tickets
Still in storage
1 storage bin
n/a
14.68
Location 10 Corn
1,486.07
6/20/2006
Producer
1 scale ticket
External railroad
1 load order
7/10/2006
1.90
Location 11 Corn
982.50
6/15/2006
Producer
1 scale ticket
Still in storage
2 storage bins
n/a
2.03
Location 12 Soybeans
500.67
6/14/2006
Producer
1 scale ticket
External trucking
1 scale ticket
7/6/2006
1.70
Location 13 Corn
483.21
6/15/2006
Producer
1 scale ticket
Still in storage
1 storage bin
n/a
1.28
Location 14 Soybeans
867.33
6/13/2006
Producer
1 scale ticket
To FC location 8
54 scale tickets
7/5/2006
7.60
Location 15 Corn
973.57
6/20/2006
Producer
1 scale ticket
Unknown feed mill
Unknown
Unknown
2.33
Location 16 Corn
757.50
6/22/2006
External trucking
1 scale ticket
Still in storage
1 storage bin
n/a
2.72
Location 17 Corn
972.86
6/16/2006
External trucking
1 scale ticket
To FC location 10
Unknown
7/3/2006
3.98
Location 18 Corn
989.64
6/16/2006
Producer
1 scale ticket
To FC location 8
Unknown
7/6/2006
19.38
Location 19 Corn
188.93
6/29/2006
Producer
1 scale ticket
To FC location 1
2 scale tickets
7/19/2006
19.63
Location 20 Corn
559.64
6/15/2006
Producer
1 scale ticket
External trucking
4 scale tickets
6/16/2006
3.85
Location 21 Soybeans
273.00
6/14/2006
Producer
1 scale ticket
To FC location 8
Unknown
6/29/2006 - 7/5/2006
3.02
20.18
Distribution of Recall Duration
7
Mock Recall Events (No.)
6
5
4
3
2
1
0
0
8
16
Time Duration of Mock Recalls (hrs.)
24
Discussion and Conclusions
FC Mock Recall Audit Results

4. RESOURCES
Audited FC results
per FDA rules:
3. INPUTS
5. PERSONNEL
1. PROCESS
7. METHODS
1. Enter Process Name and Owner
– QMS traceability is
adequate to meet
FDA mandate
– Wide variation in
duration of recalls
– Wide variation in
precision i.e. lot size
3. OUTPUTS
6. EFFECTIVENESS
FC Procedure for Recalling Commodity Grain
2. Enter details of the actual output; this may be
product or document, & should be linked to or used
as a measure of effectiveness listed in (7)
FC Mock Recall Summary Sheet (added page)
Elevator Location Manager
Duration Summary Report (added page)
Process Audit Form results (this sheet)
3. Enter details of the actual input; this may be a
document, materials, tooling, schedule, etc.
FDA Bioterrorism Act Traceability Characteristics
4. List those resources used in the process, such as:
machines, materials, equipment.
FC QMS Form, Commodity Grain Recall Record
FDA Bioterrorism Act of 2002
Checklist (note: results of study not on this recorded
List of emails initiating recall events
Form). Need a traceable record of results (not email
or uncoded Excel spreadsheet).
5. List details of personnel involved, with required
skills, criteria for competence, training requirements,
etc.
Quality Assurance Intern, Location Managers,
6. List details of methods, process controls, support
processes & measurements taken, etc.
Quality Manager, Management Trainee, Elevator
14, 17, 18, 19, 21. Unknown Precision at
Operators
Locations 15, 17, 18. Unknown Subsequent
Necessary Depth not met at Locations
User at Location 15. Timeframe not met at Location
4. Unknown finished bu quantities at all Locations.
7. List the measures to show process effectiveness,
(such as: targets, results)
FDA minimum requirements identifying immediate
source, subsequent user, quantities, and duration
(note: no trace back at any Locations)
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 CAR’s on failed recalls – close the loop
Decide on lot sizes – operations issue
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