Food Equipment North America

KENNETH R. ZABEL

*** ***** ******

Niles, MI **120

608-***-**** CELLULAR

ad5xjo@r.postjobfree.com

www.linkedin.com/in/kenzabel

SUPPLIER COMPLIANCE/CAPA/VALIDATION ENGINEER, AUDITOR, TRAINER

A high energy, resourceful, creative problem solver whose engineering, auditing, and training skills enable manufacturers and suppliers of medical devices, automotive/heavy equipment, aerospace, commercial food equipment, and others achieve their competitive edges while maintaining the highest quality standards and levels of customer service and satisfaction. Compliance management trainer, mentor, and auditor. Developed and expanded the Global Food Equipment Sanitation Certification Programs (commercial food equipment - NSF/ANSI public health safety standards) at NSF International, Intertek/ETL Semko, CSA International. PPAP, IQ/OQ/PQ, Value Stream Mapping, CAPA, Cost of Poor Quality (COPQ) Assessments.

EDUCATION

ISO 9001:2008 Lead Auditor Training - SAE; ISO 9001:2015 Transition - MRA, Caliso; AS9100D - BSI

B.B.A., Quality Management Cum Laude, Cleary University, Ann Arbor MI

Honors Biology Program, University of Michigan, Ann Arbor MI

PROFESSIONAL EXPERIENCE

QUALITY/SAFETY COMPLIANCE EXPERT (contractor) 2011 to 2012; 2014 to current

SGS North America: Sustainability Auditor (AIAG Sustainability) – suppliers to Fiat Chrysler America (FCA); QMS Auditor (ISO 9001:2008) - suppliers to Mattel; Compliance Auditor – Samsung Appliance Service Centers

Wacker Neuson (construction equipment): internal auditing upgrade to ISO 9001:2015 (STS Technical Services)

FDB Events: Design and present custom training on Quality Management and Supplier Management Systems (Dubai, 2018)

Designed Problem-Solving Team (CAPA) Process to meet Ford (8-D), Chrysler (7 Step), GM (5 Why), medical device manufacturer (21CFR 820), and military (MIL Specs) requirements (prior to ISO 9001:2000 and QS-9000)

Material Review: Utilized toxicology process at NSF International (NSF); designed, coordinated similar food contact material review against FDA 21CFR 170-199, 820 and ISO 13485 at Intertek (ETL Semko), CSA International (CSA)

Zimmer Biomet (medical devices), Supplier Remediation (FDA 403 findings), IQ/OQ/PQ, Risk Assessments; designed acceptance criteria and process to review CAPA, Risk Assessments to classify suppliers who would not compete proper special process validations – heat treatment, sterilization, plating, packaging, labeling; 21CFR, ISO 13485

EU Medical Device Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC; GDP

ISO 17025 Gap Analysis Audits: RoHS Testing Laboratory (A2LA Workplace Training AWPT)

NSF International: Electrical Safety Field Service Compliance Auditor/Assessor (NFPA 70E, 790, 791)

Speaker, Automotive Quality Management Conference (Novi, MI 2018): Benchmarking Audits of Suppliers to Identify Common Challenges & Lessons Learned in Applying New Standards (organized by Hanson Wade)

Hotel Health & Safety Auditor – Sun Hotels, TUI, Thomas Cook, Belmond, Travelsphere

Asia Inspection: Quality, Social Compliance Auditor - electronics, apparel, toys (ISO 9001, SMETA, SA8000)

Underwriters’ Laboratories - UL-STR: QMS Auditor (ISO 9001:2008); Product Verification & Validation (PV&V); Pre-production compliance assessments; inspections, evaluations; Social Compliance (SMETA) Audits

Coordinate certification processes with Certification Body (ETL, CSA, NSF, UL), train safety engineers to support certification against NSF and UL Standards: Javar (Columbia), Fuji Electric Co (Japan), Inacio de Castro Figueiredo (Brazil)

Write, update certification reports for certification agencies (UL, NSF, CSA, ETL)

Reaction Housing (temp housing units): NFPA 70, 101, 1192 (NEC, National Fire Protection Association) compliance

Strategic Materials Parker Hannifin (refrigeration filters, valves, components) ATEX 94/9/EC, 2014/34/EU [ATmosphères EXplosives] Certification Engineer: European Directives compliance/certification

Cost of Poor Quality (COPQ): costs that would disappear if systems, processes, and products were perfect

Value Stream Mapping (PFMEA): assess and redesign production product flow; Enterprise Resource Planning (ERP)

TATA CONSULTANCY SERVICES (TCS) PRODUCT STEWARDSHIP ENGINEER 2021 to 2023

Johnson & Johnson – Ethicon: RoHS and REACH compliance of surgical staplers, advanced energy devices, robotic surgery, clip appliers, and trocars used in a wide variety of minimally invasive and open surgical procedures.

RoHS Subject Matter Expert (SME): Directives 2002/95/EC, 2011/6/EU, 2015/863

REACH Review Substances of Very High Concern (SVHC): 1907/2006 - Annex XIV, XVII

Safe Drinking Water and Toxic Enforcement Act of 1986 (CA Prop 65) compliance validation

Material of Concern (MOC) Data collection (review) from suppliers, contract manufacturers

Ethicon R&D Materials, Biocompatibility & Stewardship Team; Restricted Sub. Mgmt (RSM)

Johnson & Johnson MedTech Product Stewardship Team

TAYLOR EQUIPMENT, Senior Compliance Engineer, Rockton, IL 2012 to 2013

Manufacturer of soft serve, milk shake, smoothie, frozen beverage dispensers; gourmet ice cream equipment; grills

Coordinated agency approvals - Electrical Safety (UL, ETL), Gas Safety (CSA/AGA), Sanitation (NSF), CE Approvals and IEC 60335-1 (TÜV Rhineland); assessed, coordinated compliance testing and reporting - RoHS, REACH, WEEE, ATEX, NFPA, HACCP; MSDS and compliance documentation review, acceptance, storage.

Internal Quality Systems Auditor, Trainer (ISO 17025 - SAI Global); Internal Lab Auditor (ISO 9001 - UL)

THIRD-PARTY TESTING AND CERTIFICATION BODIES

CSA INTERNATIONAL, Certification Specialist Independence, OH 2005-2010

Global Third-Party Certification Body; Division of the Canadian Standards Association

Developed and expanded CSA Sanitation Program which included evaluation and documentation of commercial food equipment against NSF/ANSI public health safety standards; conducted combined CSA Sanitation/Gas & Electrical Safety Certification projects. Reviewed manufacturers’ proposed CAPA to resolve variances cited against applicable standards.

Material Review Process (FDA 21CFR) – designed, managed process to assess material acceptability; ISO 13485

Designed and conducted training for CSA Engineers from across North America, Europe, and Asia to conduct evaluations, test commercial food equipment and integrating agency product safety certification and sanitation reports.

INTERTEK - ETL SEMKO, Sr. Sanitation Engineer Cortland, NY 2003-2005

Global Third-Party Certification Body

Evaluated, tested, and documented compliance of commercial food and pool equipment - NSF/ANSI Public Health Safety Standards and conducted performance testing at clients' facilities; reviewed CAPA proposed to resolve citations cited against applicable standard(s); prepared/reviewed ETL Safety (Gas, Electrical, Water) and Sanitation Certification Reports

Material Compliance Review (FDA 21CFR)– designed/managed new material review processes (ISO 13485)

Developed and conducted training in North America, Europe, Asia enabling engineers to also conduct evaluations and test commercial food and pool equipment against NSF/ANSI Standards; mentored/reviewed subsequent work.

NSF INTERNATIONAL Food Equip. Program Rep. Food & Pool Testing Group Leader, Ann Arbor, MI

Global Third-Party Certification Body (formerly the National Sanitation Foundation) 1989 – 1999

Evaluated, tested, tested, documented compliance of commercial food and pool/spa equipment; calibrate quages

LABORATORY: Testing Group Leader; Safety Team Member/Auditor, SAP Developer, Lab Safety/Nuclear Safety Officer

CERTIFICATION (Program Representative): Evaluated equipment, worked with manufacturers to resolve issues of non-compliance (CAPA) and obtain required documentation; trained, reviewed work of new employees

Technical Expert (Inside Sales Representative) - ISO 9000, QS-9000 Registration; HACCP 9000 Development Team

Created training and documentation guide, conducted trainings to explain how food equipment is to be evaluated, tested, documented, certified, and compliance audited; FDA 21CFR Material Compliance Process

AUTOMOTIVE/AEROSPACE MANUFACTURING QUALITY

GREAT LAKES METAL STAMPING, Quality Manager, Bridgman, MI August – November 2023

Full-service metal stamping facility providing stampings, weldments, assemblies, value-added services – automotive, aerospace, consumer products

Customer complaint resolution, System enhancements to resolve product concerns and inconsistencies

Developed Layered Process Audit (LPA), Product Audit (PA) Programs; Supplier Quality Auditor, Internal Auditor - IATF 16949, ISO 9001:2015, PPAP Preparation

Supervision of Quality Lab, Quality Engineers, Product Inspectors, Containment and Repair Personnel

BOSAL INDUSTRIES, Quality Engineer (two contractual positions), Warren, MI summers 2002, 2005

Manufacturer of automotive. aerospace exhaust systems, components.

Review & authorize Quality/Production Plans, DFMEA, PFMEA; Gage R&R

Prototype assessment & validation; PPAP Preparation, CMM use: PC-DMIS

Drove Corrective Actions (CAPA), COPQ, system enhancements ensuring compliance to ISO9002, QS-9000, TS/ISO 16949, AS-9000, ISO 14001 standards; realized reductions of external defects [68%] internal scrap [78%] - 7% to 1.5%

SPIRAL INDUSTRIES, Quality Engineer (contractual), Howell, MI 2002

Manufacturer of hose and tube assemblies: automotive, truck, tractor, aerospace customers

GD&T, CMM use, inspections: hose & bent tube products; complaint investigation, resolution/prevention (CAPA)

Implemented AS-9000 and TS/ISO 16949; DFMEA, PFMEA; Enterprise Resource Planning (ERP)

MAPCO (Merchants Automated Products Co.), Quality Control Supervisor, Canton, MI 2001 to 2002

Precision machining, lathe, grinding of metal fabricated automotive, aerospace, and custom parts

Validate CNC set up, floor and first article inspections, final audits of custom milling, grinding metallic products; prototype runs; aerospace, automotive customers. CAPA/Cost of Poor Quality (COPQ) Assessments

Supplier Quality Engineer, audited suppliers, contractors; calibrate gauges; PPAP, IQ/OQ/PQ Review

Developed GD&T, SPC and QS-9000 training and document controls; audited suppliers, contractors

EXEMPLAR MANUFACTURING, Quality Control Laboratory Supervisor, Ypsilanti, MI 1999 to 2001

Manufacturer of fasteners: automotive, military, aerospace, medical device industries; brake actuator assemblies

Designed uniform quality system, problem solving system (CAPA) to meet individual customer requirements of Ford [8-D], General Motors [Five Why], Chrysler [Seven Step], military, medical device [21CFR820] manufacturers

Developed procedures, trainings to obtain ISO 9001 & QS-9000 registration, ISO 14001 & 17025 compliance

Calibrations, QC testing of fasteners against ASTM standards for tensile strength, shearing, corrosion resistance.

Manufacturing, Certification, and Quality (ASQ/Six Sigma) Trainings designed, presented by Kenneth R. Zabel

Benchmarking Audits of Suppliers to Identify Common Challenges & Lessons Learned in Applying New Standards Automotive Quality Management Conference, Novi, MI 2018 (organized by Hanson Wade)

Best Practice ISO 9001:2015 Quality Management & Organizational Excellence - Implementing ISO based Quality Management Strategies into your organization to supercharge your business, Dubai 2018 (organized by FDB)

Certification of Commercial Food Equipment against NSF/ANSI Standards

Introduction to, establishing Quality Management Systems: ISO 9001, IAFT(TS) 16949, ISO 13485, AS9100(C, D)

Introduction to, auditing Social Management Systems: SA8000, SMETA, AIAG Sustainability, 7S (6S, 5S), WRAP

Analyze Data & Identify Root Cause

Fishbone Diagram used to identify all of the contributing root causes likely to be causing a problem

Cost of Poor Quality (COPQ) quantifying negative outcomes due to waste, inefficiencies and defects in a process.

5-Why Analysis - asking "Why?" five times, successively, to understand the ultimate root cause and complete a

Cause & Effect diagram; designed by General Motors.

8-D Problem-Solving (Eight Discipline), or Global 8D, a step-by-step problem-solving methodology popularized by Ford Motor Company: Use Team Approach; Describe the Problem; Implement &Verify Short-Term Corrective Actions; Define & Verify Root Causes, Corrective Actions; Implement Permanent Corrective Actions, Prevent Recurrence; Congratulate Team.

Regression Analysis - statistical measurement of correlation to quantify the strength of the relationship between variables

Improve Processes

System Diagrams - study of the behavior of complex systems, understand the web of relationships between activities

Error-Proofing (poka-yoke): implementation of fail-safe mechanisms to prevent a process from producing defects

6M’s (quality): Machines, Methods, Materials, Measurements, Mother Nature (Environment), Manpower (People)

Corrective Action Matrix used by problem-solving teams to keep track of who is doing what - by when

Measure & Collect Data.

RoHS - Restriction of Hazardous Substances: 2002//95EU, 2011/65/EU, 2015/863; IEC 62321-1,-2,-3-1/2,-4,-5,-6,-7-1/2,-8

GxP standards: Food and Drug Administration – to assess a range of compliance related activities to ensure that regulated organizations comply with standard processes in Traceability, Accountability, Data Integrity (G: Good; x: Variable

[C - Clinical, M - Manufacturing, L - Laboratory, S - Storage, D - Distribution, R - Review]; P - Practices)

Trend Chart (Run Charts) to show trends in data over time

Statistical Process Control (SPC) uses control charts used to plot data over time and identify both Common Cause

variation and Special Cause variation and establish control limits to detect an out-of-control or out-of-specification

Six Sigma Conversion Table - Defects Per Million Opportunities are converted to a Sigma Level (99.9997%)

Define & Prioritize Problems

Affinity Diagram to sort/consolidate information into groupings (clusters of ideas); natural ‘affinities’

Pareto Chart (Manufacturing) shows the relative frequency of defects in rank-order

Pareto Chart (Service) to rank the various categories/causes of a problem

Process Flow Chart provides a visual representation of the steps in a process - Provides understanding process;

helps to identify non-value-added operations; facilitates teamwork, communication; everyone on the same page

Failure Mode & Effects Analysis (FMEA) to prioritize potential defects based on their severity, expected

frequency, and likelihood of detection

Value-added Flow Chart to improve cycle times, productivity by visually separating non-value-adding activities

Project Priority Calculator to identify those projects that have the highest priority.

Control Processes

IQ/OQ/PQ: Installation, Operation, Performance Qualification of medical devices, including special

processes which cannot be validated; Risk Analysis of unvalidated processes, FDA 483 Letter Resolution

7S - Satisfaction added to Lean 6S – Safety added to:

5S (five Japanese words - workplace organization and housekeeping: Sort, Straighten, Sweep, Standardize, Sustain

Cost of Poor Quality (COPQ) as occurs in four areas: Internal (found defects), External (found after delivery), Appraisal (determining the degree of non-conformance), Prevention (prevent future failures, minimizing loss)

Failure Mode & Effects Analysis (FMEA) used to prioritize potential defects based on their severity, expected

frequency, and likelihood of detection - Design (DFMEA) and Process (PFMEA)

Production Product Approval Process (PPAP) preparation, updating, review, approval processes

Standards, Codes, Auditing, and Certification Experiences of Kenneth R. Zabel

Standard, Code, Certification

Agency, Company

Types of Equipment, Materials

AGA (former) American Gas Association

NSF International, Intertek (ETL Semko), CSA International, Taylor

See CSA (Canadian Standards Assoc.)

AIAG SUSTAINABILITY

SGS North America

Audit FCA (Fiat Chrysler) Suppliers

AS91000 Aerospace (AS9110, AS9120)

Exemplar, Spiral Industries, SQA, BOSAL Industries, Defense Supply

Fasteners, hose & tube assemblies, exhaust systems, military components

AS/NZS Australia, New Zealand

SAI Global

Water components, firefighting equip.

ASME American Society of Mechanical Engineers

NSF International, SAI Global, Intertek (ETL Semko)

Pool filters, hot water heaters, water components, pressure vessels

ASSE American Society of Safety Engineers,

NSF International, Intertek, Exemplar Mfg., MAPCO

Test equipment machine guarding

ASTM ASTM International

American Society for Testing and Materials

NSF International, Intertek (ETL Semko), CSA International, Exemplar Mfg., Spiral Industries

Metal strength testing, fasteners, pool filters, water heaters

ATEX [ATmosphères EXplosives]

Taylor Equipment, Parker Hannifin

Powdered mix, explosive refrigerants

BS British Standards

Intertek, Taylor Equipment, Reaction Housing

Food processing and preparation equipment, fire protection/ATEX

CCC (China Compulsory Certificate)

Intertek, Taylor Equipment

Ice Cream Makers, Ovens, Bev. Disp.

CE Mark (EC Directives)

Taylor Manufacturing, Ethicon

Ice Cream Makers, Ovens, Med. Dev.

CSA Canadian Standards Association (former AGA Standards)

NSF International, Intertek, CSA International, Taylor Manufacturing

Canadian Electrical, Water, Gas Components and Equipment

Energy Star

Taylor Manufacturing

Ice Cream Makers, Ovens, Bev. Disp.

FDA 21CFR

(Code of Federal Regulations)

NSF Inter, Intertek, CSA Intern, Taylor, Zimmer Biomet, Ethicon

Material review programs using FDA 21CFR 170-199, 210-211, 820

FCC Declaration of Conformity Federal Communications Commission

Intertek, Reaction Housing

Door sensors, alarm keypads, smoke detector/alarm systems

GS Mark

Intertek, Taylor Manufacturing

Coffee Mills & Grinders, Appliances

HACCP, HACCP-9000

NSF International, Taylor Manuf.

Hazard Analysis, Critical Control Points

IATF 16949 (previously, ISO/TS16949, QS-9000) Automotive Quality Mgmnt

NSF Int., Exemplar Mfg., MAPCO, BOSAL, Spiral Ind, Grede, GLMS

fasteners, exhaust systems, hose & tube assemblies, custom (prototype)

IEC Intern. Electrotechnical Comm.

Taylor Manuf., TÜV Rhineland

Ice Cream Makers, Ovens

ISO 9001 Quality Management Systems

(1987, 2000, 2008, 2015)

NSF Intern., Exemplar, MAPCO, Spiral Ind., BOSAL Ind., SGS, SQA Wacker Neuson, Defense Supply Mfg,

Certification agencies, audit suppliers (to Mattel, Chrysler), testing labs; obtained registrations and upgrades

ISO 13485 Medical Devices

NSF Intern., Intertek, CSA Intern., Exemplar, Zimmer Biomet, Ethicon

Material assessments, fasteners, prototype parts, orthopedic implants

ISO 14001 Environmental Quality Management Systems

NSF International, Exemplar Mfg., BOSAL Industries

Certification Agencies, Testing Laboratories, Automotive Suppliers

ISO 16949 (previously QS-9000) Automotive Quality Management

NSF Int., Exemplar Mfg., MAPCO, BOSAL, Spiral Industries, Grede

fasteners, exhaust systems, hose & tube assemblies, prototypes, castigs

ISO 17025 Laboratory Quality

(previously ISO Guide 25)

NSF Inter., Exemplar Mfg., Intertek, CSA Inter., Taylor, A2LA WPT

Testing and Calibration Laboratories, audit RoHS Testing Laboratories

MDR Medical Device Regulations

MDD Medical Device Directives

NSF International, Exemplar, MAPCO, Zimmer Biomet, Ethicon

Material, component, equipment compliance documentation

NEC National Electric Code

Reaction Housing

Temp. housing, door sensor/locks

NFPA National Fire Protection Assn

Reaction Housing

Temporary housing (NFPA 101)

NOM Norma Oficial Mexicana

Intertek, Taylor Manufacturing

refrigerators, freezers, water heaters

NRC Regulations - 10CFR

(Code of Federal Regulations)

NSF International (formerly the National Sanitation Foundation)

Submit & maintain licensing, testing - 14C-labeled media; Lab Safety Officer

NSF International

(National Sanitation Foundation)

NSF Intern., Intertek, CSA Intern., Taylor Equip, Crescent Metal Prod

Commercial Food, Pool & Spa Equip, DWTUs, Wastewater Treatmnt, PVC

REACH Registration, Evaluation, Authorization & Restriction of Chemicals

Taylor Equipment, Johnson & Johnson (Ethicon)

Ice Cream Makers, Ovens, Beverage Dispensers, Ethicon Surgical Dev.

RoHS Restriction of Hazardous Sub.

Taylor Equip., Ethicon, A2LA WPT

Ice Cream Makers, Ovens, Dispensers

UL Underwriter’s Laboratories

Intertek, CSA International,

SAI Global, Taylor Manufacturing

Commercial Food Equipment, Pool & Spa Equipment, Ice Cream Makers

WEEE Waste Electrical and Electronic Equipment Directive

Taylor Manufacturing, Johnson & Johnson (Ethicon)

Ice Cream Makers, Ovens, Bev. Disp.

1/11/2024

Kenneth R. Zabel

https://www.linkedin.com/in/kenzabel/

note: names of training events are hot-linked to more information

Problem Solving – Corrective and Preventative Actions (CAPA) – Webinar

Zabel K – Skill Preceptor CAPA - Problem Solving & Decision Making

Creative Thinking (Parallel Thinking Technique) - Webinar

Zabel K - 247 Compliance - Six Thinking Hats Webinar

ISO 9001:2015 Weekend Seminar; Zabel Bio, References

Zabel Kenneth - ISO 9001 - 2015 Best Practices Training

PUBLICATIONS

What are EU RoHS and REACH?

Zabel Kenneth - EU RoHS and REACH

RoHS: Restriction of Hazardous Substances (EU)

Zabel Kenneth - RoHS: Restriction of Hazardous Substances

Safe Drinking Water and Toxic Enforcement Act of 1986

Zabel - Kenneth - CALIFORNIA PROP 65

Sanitation Certification of Food Equipment to NSF/ANSI Standards

Zabel Kenneth - Sanitation Certification of Food Equipment

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