food safety modernization act (fsma) regulatory requirements by fda

The Voice of Opera.onal Excellence

FOOD SAFETY -‐ FACILITATING FSMA COMPLIANCE WITH TECHNOLOGY

Presented by: Jim Toman – Lead Consultant, Manufacturing IT

Introduc.on

2 | The Voice of Opera.onal Excellence

Jim Toman Lead Consultant – Manufacturing IT •  25 years of experience in manufacturing IT •  Director, MESA Interna.onal Americas Board •  MESA Recognized Prac..oner

Agenda •  Who is Grantek? •  What is FSMA? •  Addressing FSMA Compliance with Technology •  Case Study •  Q&A


Who is Grantek Office Loca9ons


•  Burlington, ON •  Montreal, QC

•  Vancouver, BC •  Chicago, IL

•  Moline, IL

•  Cleveland, OH •  Allentown, PA

•  San Francisco, CA •  Temecula, CA

Grantek

Founded in 1980 9 Offices in 2 Countries ~180 Total Employees

Grantek Capabili.es


OEM Coordina.on

Supplier Coordina.on

Corporate Headquarters Other Plants

WMS Integra.on

Packaging

Process Automa.on

Controls and Automa.on

Industrial Networking

Batching/Mixing

Building Automa.on Systems

Machine Safeguarding

Applica.ons and Ini.a.ves

MFG and Business Intelligence

Verifica.on and Compliance

MES Integra.on

Industry Involvement / Thought Leadership •  Strategic partnerships

•  Publica.ons and blog posts regarding emerging technologies and strategies

•  Working collabora.vely with industry organiza.ons such as MESA to develop best prac.ces

•  Presen.ng at industry forums for specific technology solu.ons and/or strategies


What is the Food Safety Moderniza.on Act (FSMA)? •  2010 US law delega.ng power to the FDA to regulate the industry’s food safety prac.ces

•  FDA Regula.ons are finalized in 2015 and 2016.


•  Covers food producers growing, processing, shipping and/or selling food in the United States.

•  Gives regulatory authority to the FDA, the same organiza.on responsible for regula.ng pharmaceu.cals.

FSMA Goals •  Consumer protec.on is the key goal

•  Incident Preven.on across the Supply Chain •  Rapid Response across the Supply Chain


FSMA Areas of Focus

FSMA

Food Facility Registra.on

Hazard Analysis & Preven.ve Controls

Inspec.ons

Laboratory Accredita.on

Traceability, Record Keeping

Mandatory Recall

Authority

Third Party Cer.fica.on

Import Requirements


Key FSMA Regula.on Dates Rule Finaliza9on Compliance

(General) Compliance (Small Business)

Compliance (Very Small Business)

Preven.ve Controls for Human Food

August 30, 2015 August 30, 2016 August 30, 2017 August 30, 2018

Preven.ve Controls for Food for Animals

August 30, 2015 August 30, 2016 August 30, 2017 August 30, 2018

Produce Safety October 31, 2015 October 31, 2017 October 31, 2018 October 31, 2019

Food Supplier Verifica.on Programs

October 31, 2015 May 1, 2017 May 1, 2017 May 1, 2017

Accredita.on of 3rd Party Auditors

October 31, 2015

Food Defense March 31, 2016 March 31, 2017 March 31, 2018 March 31, 2019

Sanitary Transporta.on

March 31, 2016 March 31, 2017 March 31, 2018


* From Ins.tute of Food Technologists’ website

The Role of Technology in FSMA Compliance


Accuracy Cost-‐Efficiency

Consistency Speed


FSMA Regula.on

Focus Areas

Food Safety Risks

Challenges

Opportuni.es

Technology Applica.ons

Preven.ve Controls Forensics

Undeclared Allergens

Food-‐Borne Pathogens

Uninten.onal Adulterants

FDA Audit or Recall

Incorrect Ingredients

Recipe Management

Material Verifica.on

MES Recipe Management

Centerlining

Golden Batch

ERP-‐Plant Floor Data Transfer

MES Produc.on Mgmt

Scan and Verify

Human Mistakes

Supplier Verifica.on

SOP Compliance

MES CoA Verifica.on

MES-‐LIMS Integra.on

Automated SOP’s

Role-‐Based Preflight Checklist

Role-‐Based Sanita.on Checklist

Improper Processing / Storage

Process / Enviro

Monitoring

In-‐Process Quality Control

Process Historian

MES Performance

Mgmt

SCADA Alarming

SPC

MES Quality Mgmt

Incorrect Packaging

Label Verifica.on

Vision System

Worn Equipment

Preven.ve Maintenance

Failure Detec.on /

SPC

MTBF / MTTR

Monitoring

OEE, TIS

Incomplete or Incorrect Records

Automated Traceability

MES Track & Trace

Preven.ve Controls – Recipe Management


Automated Recipe Management

• Setpoints for each product stored in database

• Data transferred to controllers at changeover when product selected

Centerlining

•  Iden.fying ideal con.nuous process setpoints based on historical knowledge

• Requires monitoring setpoints and process variables.

Golden Batch

• A type of centerlining focusing on batch runs instead of con.nuous process.


ERP

MES

SCADA

Controls

Database

Enterprise Data Bus






Centerlining



Golden Batch



ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian






Centerlining



Golden Batch



ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Batch Manager

Historian

Preven.ve Controls – Material Verifica.on



• Process Orders and Bill of Materials transferred from ERP

MES Produc.on Management

• Dispatch and run a process order on a line.

• Ingredients to make a product are known at the line.

Scan and Verify

• Scan a material ID when it is being consumed into the process.

• Compare material ID against the BOM to prevent mistakes.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal Enterprise

Data Bus








Scan and Verify



ERP

MES

SCADA

Controls

Database


Data Bus

Batch Manager

Historian








Scan and Verify



ERP

MES

SCADA

Controls

Database Batch

Manager

Bar Codes RFID

Preven.ve Controls – Supplier Verifica.on


MES CoA Verifica.on

• Cer.ficate of Analysis imported to MES electronically.

• Sample and test raw material.

MES LIMS Integra.on

• Exchange test data with Laboratory Informa.on Management System (LIMS).

ERP

MES

SCADA

Controls

Database


Data Bus

Preven.ve Controls – Supplier Verifica.on


MES CoA Verifica.on

• Cer.ficate of Analysis imported to MES electronically.

• Sample and test raw material.

MES LIMS Integra.on

• Exchange test data with Laboratory Informa.on Management System (LIMS).

ERP

MES

SCADA

Controls

Database


Data Bus LIMS Integra.on

Preven.ve Controls – SOP Compliance


Automated SOP’s

• SOP’s stored and displayed electronically

Role-‐based Preflight Checklist

• Enforced checklist of ac.ons based on operator role prior to star.ng equipment.

Role-‐based CIP Checklist

• Enforced checklist of ac.ons based on operator role upon cleaning.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal



Automated SOP’s






ERP

MES

SCADA

Controls

Database

Repor.ng Portal



Automated SOP’s






ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Batch Manager

Preven.ve Controls – Label Verifica.on


Vision System

• Labels imaged and verified against current product being made.

ERP

MES

SCADA

Controls

Database

Machine Vision

Bar Codes RFID

Preven.ve Controls – Process/Environmental Monitoring


Process Historian

• Cri.cal process variables tracked on a .med basis.

• Process variables trended based on a .me frame.

MES Performance Management

• Capture and analysis of run rates and .me to order comple.on.

SCADA Alarming

• When key tracked variables go out of acceptable limits, alarm the operator.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian



Process Historian





SCADA Alarming


ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian



Process Historian





SCADA Alarming


ERP

MES

SCADA

Controls

Database

Historian

Preven.ve Controls – In-‐Process Quality Control


Sta.s.cal Process Control (SPC)

• Monitor cri.cal quality values and alarm when trending out of control limits.

MES Quality Management

• Perform in-‐process quality tes.ng and record results against the process order.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian

Preven.ve Controls – In-‐Process Quality Control


Sta.s.cal Process Control (SPC)

• Monitor cri.cal quality values and alarm when trending out of control limits.

MES Quality Management

• Perform in-‐process quality tes.ng and record results against the process order.

ERP

MES

SCADA

Controls

Database


Data Bus LIMS Integra.on

Preven.ve Controls – Preventa.ve Maintenance


Failure Detec.on

• Iden.fy equipment nearing failure to schedule PM sooner

MTTR, MTBF

• Iden.fy repair .mes and interval between failures to schedule PM sooner

OEE, TIS

• Track down.me, throughput and quality to ensure most efficient opera.on.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian



Failure Detec.on


MTTR, MTBF


OEE, TIS


ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian

Fast Forensics – Track and Trace CTE’s


Cri9cal Tracking Events (CTE) –  Transporta.on

•  Shipping •  Receiving

–  Transforma.on •  Input to Process •  Output of Process

–  Deple.on •  Consump.on •  Disposal

External

Internal

Fast Forensics – Track and Trace KDE’s


Fast Forensics – Track and Trace


MES Track and Trace

• Materials in and out are iden.fied and tracked at each point in the process, from raw materials to packaging.

ERP

MES

SCADA

Controls

Database

Repor.ng Portal

Historian

LIMS Integra.on

Machine Vision

Bar Codes RFID

Case Study – Hillshire Brands •  Food Safety Focus Areas

–  Process Monitoring –  Product distribu.on/flow through plant –  Label verifica.on

•  Food Safety – Processes –  Verifica.on of process parameters –  Current back up to quality repor.ng –  Possible replacement –  Repor.ng

•  Processes involved –  Cooking (CCP) –  Chilling/Freezing (CCP) –  Frying –  Clean in Place systems

•  Discovered a food safety issue with cooking sausage to proper temperatures.

•  Used FactoryTalk Historian and FactoryTalk VantagePoint to iden.fy the issue and verify correc.ve ac.ons.


Agenda •  Who is Grantek? •  What is FSMA? •  Addressing FSMA Needs with Technology •  Case Study •  Q&A


For More Informa.on… •  Jim Toman – Lead Consultant, Manufacturing IT – 951-‐252-‐3373 (mobile) –  [email protected]

•  Joe Malter – Director, Western Region – 925-‐324-‐6613 –  [email protected]
