Iowa Grain Quality InitiativeAdvisory Committee Meeting: 1/12/07Chad LauxIndustrial and Agricultural Technology Program

Dr. Charles Hurburgh, Jr. Major Professor

The Impact of an Auditable Quality Management System in a Grain Elevator Application

The Impact of an Auditable Quality Management System in a Grain Elevator Application

OutlineOutline

Farmer’s CooperativeResults of QMS in Quality ControlFDA Bioterror ActFC Mock Recall Results

Farmers Cooperative CompanyFarmers Cooperative Company

Northwest Iowa Company

Over $400 million in salesOver $400 million in sales

50 locations and growing50 locations and growing

350+ employees350+ employees

Departments: Grain, Departments: Grain,

Agronomy, Feed, Seed, Agronomy, Feed, Seed,

Admin., AccountingAdmin., Accounting

Source: FC, 2006

Problem StatementProblem 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 DefinedCore Farmer’s Cooperative Co. Processes: ISO Defined

Processes which transform the end product in ISO structure

8.3.1 Control of Nonconforming Grain

8.2.5 Final Inspection

8.2.4 In-process Inspections

7.5.5 Preservation of Grain-Bulk Grain Shipping

7.5.5 Preservation of Grain-Storage Areas

7.5.5 Preservation of Grain-Handling and Preservation

7.5.3 Identification and Tracking-Inspection and Grading

7.5.3 Identification and Tracking- Grain Identification and Tracking

7.5.1 Control of Operations-Release & Post Shipping

7.5.1 Control of Operations-Loading Order

7.4.3 Verification of Purchased Product

7.2.1 Order Processing for Gain Shipments

Shipping

Storage

Storage

Storage

Storage

Storage

Storage

All 3

Shipping

Shipping

Receiving

Shipping

Statistical Process Control - Grain GradingStatistical 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 & HypothesisResearch Model & Hypothesis

Grain quality for shipment is improved when QMS procedures are adoptedFC/FGIS/customer comparisons of same sample:

Corn Moisture - Content Instrument FactorCorn Damage - Visual Judgment FactorSmaller Difference is Better!

Comparison of:QMS locations vs. non-QMS locationsLocations before and after QMS implementation

FC-O

ffic

ial (

% p

ts)

NoneISOAIB

0.5

0.4

0.3

0.2

0.1

0.0

Moisture Content Absolute Mean DifferenceMoisture Content Absolute Mean Difference

All Locations

w/ SEM’s shown n=15087 n=279n=218

FC-O

ffic

ial (

% p

ts)

Before QSEAfter QSE

0.5

0.4

0.3

0.2

0.1

0.0

Moisture Content Absolute Mean Difference – Location 1Moisture Content Absolute Mean Difference – Location 1

Before and After AIB/QSE Adoption

w/ SEM’s shown n=218 n=2924

FC-O

ffic

ial (

% p

ts)

Before QMSAfter

0.5

0.4

0.3

0.2

0.1

0.0

Moisture Content Absolute Mean Difference – Location 2Moisture Content Absolute Mean Difference – Location 2

Before and After QMS Adoption

w/ SEM’s shown N=279 N=2864

FC-O

ffic

ial (

% p

ts)

NoneISOAIB

5

4

3

2

1

0

Total Points % Damage Absolute Mean DifferenceTotal Points % Damage Absolute Mean Difference

All Locations

w/ SEM’s shown n=79 n=110 n=5303

FC-O

ffic

ial (

% p

ts)

Before QSEAfter QSE

5

4

3

2

1

0

Total Points % Damage Absolute Mean Difference– Location 1Total Points % Damage Absolute Mean Difference– Location 1

Before and After AIB/QSE Adoption

w/ SEM’s shown n=79 n=1197

FC-O

ffic

ial (

% p

ts)

Before QMSAfter

10

8

6

4

2

0

Total Points % Damage Absolute Mean Difference – Location 2Total Points % Damage Absolute Mean Difference – Location 2

Before and After QMS Adoption

w/ SEM’s shown n=110 n=1637

ConclusionsConclusions

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

How to Meet the FDA Bioterrorism Act: An Elevator Case Study of Tracking Commodity Grain Using ISO 9000

Bioterrorism Act of 2002Bioterrorism 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 TraceabilityProduct 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?

MethodologyMethodology

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 ResultsRecall Summary ResultsLocation 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 3.02

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 20.18

Distribution of Recall DurationDistribution of Recall Duration

241680

7

6

5

4

3

2

1

0

Time Duration of Mock Recalls (hrs.)

Moc

k R

ecal

l Eve

nts

(No.

)

Discussion and ConclusionsDiscussion 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

FC Mock Recall Audit Results

1. Enter Process Name and Owner 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 Procedure for Recalling Commodity Grain 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.

4. List those resources used in the process, such as: machines, materials, equipment.

FDA Bioterrorism Act Traceability Characteristics 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.

6. List details of methods, process controls, support processes & measurements taken, etc.

Quality Assurance Intern, Location Managers, Necessary Depth not met at Locations

Quality Manager, Management Trainee, Elevator 14, 17, 18, 19, 21. Unknown Precision at

Operators Locations 15, 17, 18. Unknown Subsequent

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)

(note: no trace back at any Locations)

FDA minimum requirements identifying immediate source, subsequent user, quantities, and duration

4. RESOURCES

3. INPUTS

7. METHODS

5. PERSONNEL

3. OUTPUTS

6. EFFECTIVENESS

1. PROCESS

RecommendationsRecommendations

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 StepsFinal 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