the impact of an auditable quality management system in a grain elevator application
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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