SlideShare a Scribd company logo
1 of 17
Kenneth G. Bolt
    Sara Lee Foods
QA Applications Manager
Who I am
• Electrical engineer who can speak, understand, execute, and
  manage IT.

• Focused on customer value and business improvement.

• Specialties are manufacturing and business process design,
  automation, control, and continuous improvement

• Outstanding technical, interpersonal, and communication skills

• Unparalleled work ethic
Sara Lee Supply Chain Role
• Provided technical leadership and project management to
  successfully design and implement a highly innovative and unique
  LIMS system for all North America

• Managed other supply chain & R&D tools: Achiever, Genesis,
  EZform

• Interfaced ERP system: JD Edwards and specification system:
  Achiever
Accomplishments
• Expanded LIMS scope beyond QA chemistry to include SPC, Food
  Safety, Regulatory Compliance, and NR Management.

• Defined business requirements, process models, and data models
  to meet expanded scope

• Designed unique and innovative LIMS modules to accomplish
  expanded project objectives.

• Created, executed, and managed project plan

• Negotiated with vendor to deliver expanded scope within original
  project budget.

• Rolled out system and trained users
QA SPC Control Charts
Innovative & Unique LIMS
    Functionality for Foods
• Microbiology
         e.g. 9 CFR Part 430 & FSIS Directive 10240.4 (Listeria
          monocytogenes)

• USDA NR (Noncompliance Record)
         FSIS Directive 5400.5 (part of Pathogen Reduction-Hazard
          Analysis and Critical Control Point (HACCP) Systems final rule
          July 1996)

• PFF (Protein Fat Free)
         9 CFR Chapter 3, Section 318.19

• Fat + Added Water
         FSIS Directive 7140.2
Microbiology
• Supports work flow standardization, timeliness and accuracy in the
  microbiology (e.g. Listeria Monocytogenes) environmental sample
  testing procedure.

• Provides a configurable method for food processing facilities to
  manage, store, report and access data from their sample testing
  process.

• Designed to aid food processors with their compliance of regulatory
  programs such as 9 CFR Part 430 and FSIS Directive 10240.4.
Microbiology
Microbiology
• Manage, store, report and access data from the
  microbiology environmental sample testing procedure.
• Features and Benefits
  include:
      Load Balanced Sample
       Set Selection
      Non-routine Test
       Scheduler
      Action Items
      External Lab Interface
Microbiology
• Features and Benefits continued:
      Work flow standardization
      Document Encapsulation
      Scheduling Calendar
      Automatic E-mail
      Configurability
      Report Generation
USDA NR
        (Noncompliance Record)
• An intuitive tool for managing USDA FSIS Noncompliance Record
  (NR) Form 5400-4.

• Allows the user to focus on root-cause(s) and determine the
  reasons, circumstances, and responsible parties of noncompliance
  events.

• Provides a flexible method to store, access, manage and report all
  facets of an NR.
USDA NR
• Manage USDA FSIS NR Form 5400-4.
• Features and Benefits include:
      Track NR Incidents
      Document Encapsulation
      Standardize Correspondence
      Automatic E-mail
      Configurability
      On-line Review
      Security
USDA NR Analysis
USDA NR Reports
Fat + Added Water
                Regulatory Control
• An automated Fat + Added Water Program that promotes
  compliance with FSIS Directive 7140.2.

• Increases efficiency and control by calculating and analyzing data
  for Added Water in course ground product and/or Fat and Added
  Water in emulsified product.

• Utilizes the “Zone Method” to analyze the data values.

• Control Charts and notifications monitor the data and send alerts
  when attention is required.
PFF Regulatory Control
• An automated PFF (Protein Fat Free) Control Program to improve
  the quality control and manufacturing process for ham processors.

• Calculates and analyzes the PFF and CUSUM values necessary to
  comply with the PFF Regulation (9CFR Chapter 3, Section 318.19).

• Control Charts and notifications monitor the data and send alerts
  when attention is required.

• The tighter control creates ability to maximize pump without
  exceeding government limits, consequently reducing product
  retention and maximizing profits.
Good News!
•   The work accomplished for Sara Lee was designed to be transferred to any
    food company with minimal effort.

•   The cost to implement is extremely low.

•   The expert resource to lead the effort is available from me.

•   My expert services are also available to lead any process improvement
    effort.

•   I want to be a member of your team to increase customer value and
    improve the business.

                            Kenneth G. Bolt
                               Ken.G.Bolt@gmail.com
                                   513-560-6884

More Related Content

What's hot

Instant GMP Compliance Series for Dietary Supplements – Cost of Compliance
Instant GMP Compliance Series for Dietary Supplements – Cost of ComplianceInstant GMP Compliance Series for Dietary Supplements – Cost of Compliance
Instant GMP Compliance Series for Dietary Supplements – Cost of ComplianceInstantGMP™
 
Guidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGuidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGlobal Manager Group
 
Rich McGuire f 0116 linkedin
Rich McGuire f 0116 linkedinRich McGuire f 0116 linkedin
Rich McGuire f 0116 linkedinRich McGuire
 
SAI Global Webinar: BRC Food Safety Issue 8
SAI Global Webinar: BRC Food Safety Issue 8SAI Global Webinar: BRC Food Safety Issue 8
SAI Global Webinar: BRC Food Safety Issue 8Switzerland09
 
The Value of an Engaged Workforce for the Food Industry
The Value of an Engaged Workforce for the Food IndustryThe Value of an Engaged Workforce for the Food Industry
The Value of an Engaged Workforce for the Food IndustryAlchemy Systems
 
Validation and Verification of HACCP Plans - Webinar Presentation
Validation and Verification of HACCP Plans - Webinar PresentationValidation and Verification of HACCP Plans - Webinar Presentation
Validation and Verification of HACCP Plans - Webinar PresentationSAIGlobalAssurance
 
Electronic batch manufacturing record
Electronic batch manufacturing recordElectronic batch manufacturing record
Electronic batch manufacturing recordRatan Agarwal
 
Preparing for your Food Safety Audit
Preparing for your Food Safety AuditPreparing for your Food Safety Audit
Preparing for your Food Safety AuditPECB
 
Presentation - G Howlett - BRC Issue 6 Seminar
Presentation - G Howlett - BRC Issue 6 SeminarPresentation - G Howlett - BRC Issue 6 Seminar
Presentation - G Howlett - BRC Issue 6 Seminarsafefood360
 
InstantGMP Cmpliance Series - Packaging and Labeling
InstantGMP Cmpliance Series - Packaging and LabelingInstantGMP Cmpliance Series - Packaging and Labeling
InstantGMP Cmpliance Series - Packaging and LabelingInstantGMP™
 
updated resume-suman
updated resume-sumanupdated resume-suman
updated resume-sumansuman raj
 
Types of manufacturing processes sumit verma MBA 2nd sem
Types of manufacturing processes sumit verma MBA 2nd semTypes of manufacturing processes sumit verma MBA 2nd sem
Types of manufacturing processes sumit verma MBA 2nd semSumit Verma
 

What's hot (20)

Instant GMP Compliance Series for Dietary Supplements – Cost of Compliance
Instant GMP Compliance Series for Dietary Supplements – Cost of ComplianceInstant GMP Compliance Series for Dietary Supplements – Cost of Compliance
Instant GMP Compliance Series for Dietary Supplements – Cost of Compliance
 
Guidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirementsGuidance on BRC food issue 8 documentation requirements
Guidance on BRC food issue 8 documentation requirements
 
What's New in BRC Food Safety Issue 8
What's New in BRC Food Safety Issue 8What's New in BRC Food Safety Issue 8
What's New in BRC Food Safety Issue 8
 
Rich McGuire f 0116 linkedin
Rich McGuire f 0116 linkedinRich McGuire f 0116 linkedin
Rich McGuire f 0116 linkedin
 
SAI Global Webinar: BRC Food Safety Issue 8
SAI Global Webinar: BRC Food Safety Issue 8SAI Global Webinar: BRC Food Safety Issue 8
SAI Global Webinar: BRC Food Safety Issue 8
 
The Value of an Engaged Workforce for the Food Industry
The Value of an Engaged Workforce for the Food IndustryThe Value of an Engaged Workforce for the Food Industry
The Value of an Engaged Workforce for the Food Industry
 
Validation and Verification of HACCP Plans - Webinar Presentation
Validation and Verification of HACCP Plans - Webinar PresentationValidation and Verification of HACCP Plans - Webinar Presentation
Validation and Verification of HACCP Plans - Webinar Presentation
 
MADHUKUMAR GOWDRU Updated
MADHUKUMAR GOWDRU UpdatedMADHUKUMAR GOWDRU Updated
MADHUKUMAR GOWDRU Updated
 
suman-SSS
suman-SSSsuman-SSS
suman-SSS
 
Electronic batch manufacturing record
Electronic batch manufacturing recordElectronic batch manufacturing record
Electronic batch manufacturing record
 
ISO 22000
ISO 22000ISO 22000
ISO 22000
 
Preparing for your Food Safety Audit
Preparing for your Food Safety AuditPreparing for your Food Safety Audit
Preparing for your Food Safety Audit
 
Presentation - G Howlett - BRC Issue 6 Seminar
Presentation - G Howlett - BRC Issue 6 SeminarPresentation - G Howlett - BRC Issue 6 Seminar
Presentation - G Howlett - BRC Issue 6 Seminar
 
N
NN
N
 
In process control in food industry
In process control in food industryIn process control in food industry
In process control in food industry
 
BRC ISSUE 7 DRAFT
BRC ISSUE 7 DRAFTBRC ISSUE 7 DRAFT
BRC ISSUE 7 DRAFT
 
InstantGMP Cmpliance Series - Packaging and Labeling
InstantGMP Cmpliance Series - Packaging and LabelingInstantGMP Cmpliance Series - Packaging and Labeling
InstantGMP Cmpliance Series - Packaging and Labeling
 
updated resume-suman
updated resume-sumanupdated resume-suman
updated resume-suman
 
Types of manufacturing processes sumit verma MBA 2nd sem
Types of manufacturing processes sumit verma MBA 2nd semTypes of manufacturing processes sumit verma MBA 2nd sem
Types of manufacturing processes sumit verma MBA 2nd sem
 
Brc auditor check list
Brc auditor check listBrc auditor check list
Brc auditor check list
 

Similar to Ken Bolt QA Applications Manager

Smart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Smart Pharmaceutical Consulting - Lean Manufacturing of PharmaceuticalsSmart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Smart Pharmaceutical Consulting - Lean Manufacturing of PharmaceuticalsChristopher Macklin
 
E Ferraro Resume 061215
E Ferraro Resume 061215E Ferraro Resume 061215
E Ferraro Resume 061215Erin Ferraro
 
Vanchha Sahu CV_QA_Mylan Nashik
Vanchha Sahu CV_QA_Mylan NashikVanchha Sahu CV_QA_Mylan Nashik
Vanchha Sahu CV_QA_Mylan Nashikvanchha sahu
 
2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
 
Scott_D_Jensen_resume 022816
Scott_D_Jensen_resume 022816Scott_D_Jensen_resume 022816
Scott_D_Jensen_resume 022816Scott Jensen
 
Ken Bolt Resume 2011 01 14
Ken Bolt Resume 2011 01 14Ken Bolt Resume 2011 01 14
Ken Bolt Resume 2011 01 14kengb6
 
J. Perrin Experienced Manager
J. Perrin Experienced ManagerJ. Perrin Experienced Manager
J. Perrin Experienced ManagerJennifer Perrin
 
Empower Your Business with Top Integrated Management Software
Empower Your Business with Top Integrated Management SoftwareEmpower Your Business with Top Integrated Management Software
Empower Your Business with Top Integrated Management SoftwareEffivity
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp complianceJRamniwas
 
Wp 5 tips for managing food and beverage supply chain (by IFS, KaizenVietnam...
Wp 5 tips for managing food and beverage supply chain  (by IFS, KaizenVietnam...Wp 5 tips for managing food and beverage supply chain  (by IFS, KaizenVietnam...
Wp 5 tips for managing food and beverage supply chain (by IFS, KaizenVietnam...KAIZEN Group Experts
 
Get a Sneak Peek at SQF Edition 8
Get a Sneak Peek at SQF Edition 8Get a Sneak Peek at SQF Edition 8
Get a Sneak Peek at SQF Edition 8TraceGains
 
Statistical Process Control Tools
Statistical Process Control ToolsStatistical Process Control Tools
Statistical Process Control ToolsRaja Farhan Saeed
 
CV (Professional) - Mr Graham P Alvey
CV (Professional) - Mr Graham P AlveyCV (Professional) - Mr Graham P Alvey
CV (Professional) - Mr Graham P AlveyGraham Alvey
 
Quality Darral Addison format 01112016
Quality Darral Addison format 01112016Quality Darral Addison format 01112016
Quality Darral Addison format 01112016larrad2
 

Similar to Ken Bolt QA Applications Manager (20)

Smart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Smart Pharmaceutical Consulting - Lean Manufacturing of PharmaceuticalsSmart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Smart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
 
shivbachan kushwaha Resume
shivbachan kushwaha Resumeshivbachan kushwaha Resume
shivbachan kushwaha Resume
 
E Ferraro Resume 061215
E Ferraro Resume 061215E Ferraro Resume 061215
E Ferraro Resume 061215
 
Vanchha Sahu CV_QA_Mylan Nashik
Vanchha Sahu CV_QA_Mylan NashikVanchha Sahu CV_QA_Mylan Nashik
Vanchha Sahu CV_QA_Mylan Nashik
 
MCS
MCS MCS
MCS
 
2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde2016-06-08 FDA Inspection Readiness - Mikael Yde
2016-06-08 FDA Inspection Readiness - Mikael Yde
 
Scott_D_Jensen_resume 022816
Scott_D_Jensen_resume 022816Scott_D_Jensen_resume 022816
Scott_D_Jensen_resume 022816
 
What is Quality Management System | QMS System
What is Quality Management System | QMS SystemWhat is Quality Management System | QMS System
What is Quality Management System | QMS System
 
Ken Bolt Resume 2011 01 14
Ken Bolt Resume 2011 01 14Ken Bolt Resume 2011 01 14
Ken Bolt Resume 2011 01 14
 
J. Perrin Experienced Manager
J. Perrin Experienced ManagerJ. Perrin Experienced Manager
J. Perrin Experienced Manager
 
Empower Your Business with Top Integrated Management Software
Empower Your Business with Top Integrated Management SoftwareEmpower Your Business with Top Integrated Management Software
Empower Your Business with Top Integrated Management Software
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp compliance
 
Jacqualene paige sanders
Jacqualene paige sandersJacqualene paige sanders
Jacqualene paige sanders
 
Wp 5 tips for managing food and beverage supply chain (by IFS, KaizenVietnam...
Wp 5 tips for managing food and beverage supply chain  (by IFS, KaizenVietnam...Wp 5 tips for managing food and beverage supply chain  (by IFS, KaizenVietnam...
Wp 5 tips for managing food and beverage supply chain (by IFS, KaizenVietnam...
 
Get a Sneak Peek at SQF Edition 8
Get a Sneak Peek at SQF Edition 8Get a Sneak Peek at SQF Edition 8
Get a Sneak Peek at SQF Edition 8
 
Jackie (2)
Jackie (2)Jackie (2)
Jackie (2)
 
Statistical Process Control Tools
Statistical Process Control ToolsStatistical Process Control Tools
Statistical Process Control Tools
 
CV (Professional) - Mr Graham P Alvey
CV (Professional) - Mr Graham P AlveyCV (Professional) - Mr Graham P Alvey
CV (Professional) - Mr Graham P Alvey
 
shivam saxena
shivam saxenashivam saxena
shivam saxena
 
Quality Darral Addison format 01112016
Quality Darral Addison format 01112016Quality Darral Addison format 01112016
Quality Darral Addison format 01112016
 

Ken Bolt QA Applications Manager

  • 1. Kenneth G. Bolt Sara Lee Foods QA Applications Manager
  • 2. Who I am • Electrical engineer who can speak, understand, execute, and manage IT. • Focused on customer value and business improvement. • Specialties are manufacturing and business process design, automation, control, and continuous improvement • Outstanding technical, interpersonal, and communication skills • Unparalleled work ethic
  • 3. Sara Lee Supply Chain Role • Provided technical leadership and project management to successfully design and implement a highly innovative and unique LIMS system for all North America • Managed other supply chain & R&D tools: Achiever, Genesis, EZform • Interfaced ERP system: JD Edwards and specification system: Achiever
  • 4. Accomplishments • Expanded LIMS scope beyond QA chemistry to include SPC, Food Safety, Regulatory Compliance, and NR Management. • Defined business requirements, process models, and data models to meet expanded scope • Designed unique and innovative LIMS modules to accomplish expanded project objectives. • Created, executed, and managed project plan • Negotiated with vendor to deliver expanded scope within original project budget. • Rolled out system and trained users
  • 5. QA SPC Control Charts
  • 6. Innovative & Unique LIMS Functionality for Foods • Microbiology  e.g. 9 CFR Part 430 & FSIS Directive 10240.4 (Listeria monocytogenes) • USDA NR (Noncompliance Record)  FSIS Directive 5400.5 (part of Pathogen Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems final rule July 1996) • PFF (Protein Fat Free)  9 CFR Chapter 3, Section 318.19 • Fat + Added Water  FSIS Directive 7140.2
  • 7. Microbiology • Supports work flow standardization, timeliness and accuracy in the microbiology (e.g. Listeria Monocytogenes) environmental sample testing procedure. • Provides a configurable method for food processing facilities to manage, store, report and access data from their sample testing process. • Designed to aid food processors with their compliance of regulatory programs such as 9 CFR Part 430 and FSIS Directive 10240.4.
  • 9. Microbiology • Manage, store, report and access data from the microbiology environmental sample testing procedure. • Features and Benefits include:  Load Balanced Sample Set Selection  Non-routine Test Scheduler  Action Items  External Lab Interface
  • 10. Microbiology • Features and Benefits continued:  Work flow standardization  Document Encapsulation  Scheduling Calendar  Automatic E-mail  Configurability  Report Generation
  • 11. USDA NR (Noncompliance Record) • An intuitive tool for managing USDA FSIS Noncompliance Record (NR) Form 5400-4. • Allows the user to focus on root-cause(s) and determine the reasons, circumstances, and responsible parties of noncompliance events. • Provides a flexible method to store, access, manage and report all facets of an NR.
  • 12. USDA NR • Manage USDA FSIS NR Form 5400-4. • Features and Benefits include:  Track NR Incidents  Document Encapsulation  Standardize Correspondence  Automatic E-mail  Configurability  On-line Review  Security
  • 15. Fat + Added Water Regulatory Control • An automated Fat + Added Water Program that promotes compliance with FSIS Directive 7140.2. • Increases efficiency and control by calculating and analyzing data for Added Water in course ground product and/or Fat and Added Water in emulsified product. • Utilizes the “Zone Method” to analyze the data values. • Control Charts and notifications monitor the data and send alerts when attention is required.
  • 16. PFF Regulatory Control • An automated PFF (Protein Fat Free) Control Program to improve the quality control and manufacturing process for ham processors. • Calculates and analyzes the PFF and CUSUM values necessary to comply with the PFF Regulation (9CFR Chapter 3, Section 318.19). • Control Charts and notifications monitor the data and send alerts when attention is required. • The tighter control creates ability to maximize pump without exceeding government limits, consequently reducing product retention and maximizing profits.
  • 17. Good News! • The work accomplished for Sara Lee was designed to be transferred to any food company with minimal effort. • The cost to implement is extremely low. • The expert resource to lead the effort is available from me. • My expert services are also available to lead any process improvement effort. • I want to be a member of your team to increase customer value and improve the business. Kenneth G. Bolt Ken.G.Bolt@gmail.com 513-560-6884