North America Food Equipment

KENNETH R. ZABEL

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

Niles, MI **120

608-***-**** CELLULAR

***.*******.*****@*****.***

www.linkedin.com/in/kenzabel

COMPLIANCE/QUALITY/CAPA/VALIDATION MANAGER, ENGINEER, AUDITOR, TRAINER

Quality, Environmental Health & Safety: High energy, resourceful, creative problem solver whose engineering, auditing, and training skills enable manufacturers (and suppliers) of commercial food equipment, medical devices, automotive/heavy equipment, aerospace, and other organizations achieve competitive edges while maintaining high quality and safety standards, high levels of customer 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 Certification Bodies NSF International, Intertek/ETL Semko, and CSA International. Environmental Product Stewardship: RoHS, REACH, WEEE, CA Prop 65 compliance.

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 - 2012; 2014 - current

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

Value Stream Mapping (PFMEA): assess, redesign production flow to minimize ergonomic and contaminant risk

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

SMETA - Contractual Internal Audit, Training for Gorilla Glue Corporate Headquarters

SGS North America: Sustainability Auditor (AIAG Sustainability) – suppliers to Fiat Chrysler America (FCA) – ensure social, environmental and governance responsibility are consistent with applicable laws and international standards;

Compliance Auditor - Samsung Appliance Service Centers – customer satisfaction, chemical, physical, contaminant risk;

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

Designed Problem-Solving Team (CAPA) Process to meet Ford (8-D), Chrysler (7 Step), GM (5 Why), military (MIL Specs), and medical device manufacturer (21CFR 820) 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)

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)

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

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

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

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

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

Strategic Materials: Quality Engineer/Manager, incoming, outgoing material supervision of critical-to-quality outputs

TATA CONSULTANCY SERVICES (TCS), Nashotah, WI July 2021 - Jun 2023

JOHNSON & JOHNSON – ETHICON ENDO SURGERY, Cincinnati, OH (remote) July 2021 - Dec 2022

Product Stewardship Engineer: Ethicon Surgical Equipment - RoHS, REACH, CA-65, WEEE compliance

Restriction of Hazardous Substances (RoHS) Subject Mater Expert (SME): Directives 2011/6/EU, 2015/863

Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation No. 1907/2006

Safe Drinking Water and Toxic Enforcement Act of 1986 (California Proposition 65) compliance validation

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

Johnson & Johnson MedTech Product Stewardship Team Member

TAYLOR EQUIPMENT, Senior Compliance Engineer, Rockton, IL 2012 - 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 - NFPA, HACCP, RoHS, REACH, WEEE, ATEX; MSDS and compliance documentation review, acceptance, storage.

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

Value Stream Mapping of all production lines to eliminate travel, reduce production time, prevent ergonomic hazards.

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 the standards.

FDA 21CFR Material Review Process – 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

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.

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

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 public health safety compliance of commercial food and pool/spa equipment

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

CERTIFICATION (Sr. 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 (non-toxicity) 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

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

Developed Layered Process Audit (LPA), Product Audits (PA) Programs; PPAP Preparation

Supplier Quality Auditor, Internal Auditor - IATF 16949, ISO 9001:2015

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.

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%] and internal scrap [7% to 1.5%]

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

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

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

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

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

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

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; PPAP, IQ/OQ/PQ Review

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

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

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

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, and medical device [21CFR820] manufacturers (prior to ISO 9001, QS-9000); medical device packaging

Developed procedures, trainings to obtain QS-9000 registration with ISO 9001, 13485, 14001 & 17025 compliance

Manufacturing, Certification, and Quality (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.

7 Step Problem Solving, a structured basis designed by Chrysler to help deliver outcomes and solutions to problems

Find the Right Problems to Solve, Define the Problem, Analyze the Problem, Develop Opportunities, Select the

Best Solution, Implement, Evaluate and Learn; designed by Chrysler Corporation,

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 can be calculated (least squares method) to quantify

the strength of the relationship between variables

Improve Processes

Six Thinking Hats - when working towards a goal without a clear solution, change your hat, change your perspective

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

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)

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)

Statistical Process Control (SPC) uses control charts used to plot data over time and identify both Common and Special Cause variation and to establish control limits to detect an out-of-control or out-of-specification condition

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

Kenneth R. Zabel https://www.linkedin.com/in/kenzabel/ ***.*******.*****@*****.***

Click links below to access documentation

PUBLICATIONS (each was created by Kenneth Zabel)

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 *

* by NSF International, ETL Semko (Intertek), CSA International (Canadian Standards Association), Underwriters’ Laboratories

Zabel Kenneth - Sanitation Certification of Food Equipment

MISC

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

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

ISO 9001:2015 Weekend Workshop; includes Zabel Bio, References

Zabel Kenneth - ISO 9001 - 2015 Best Practices Training

5/20/2025

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