Managing and Documentation of Sanitation Programs

Ron Hall Don Bredeman

Ecolab Food & BeverageNorthwest District

Customer Perspectives

Don McMullen Production Superintendent

Margarito Vidrio Sanitation Manger

Rob Wiskerchen Plant Manager Chris Mone, Quality Control Manger

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GMPs - Good Manufacturing Practices

21 CFR 110 - Federal Law

Minimum Standards Food - Manufacturing, Packing, Distribution Adulteration Unfit of Human Consumption Unsanitary Conditions that MAY Contaminate or be Injurious to Health
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Risk, Rules, Reactions will continue to change

Sanitation

program must continue to evolve with the changes in business

In

the past Continuous Improvement was the focus

Today

Food Manufacturers are expected know how to produce SAFE Food and predict future risks

People at Risk

Under 1 year Old Over 60 years Old Aids Patients Immuno Compromised

Chemo therapy

Pregnancy

Department of Economic and Social Affairs Population Division

Food marketers must prepare for 'YouTube' Generation

International food industry executives attending the Healthy Foods Summit in London were urged by Lori Colman, chief executive officer of Chicago marketing firm Colman Brohan Davis, when looking toward the year 2020 to step up their efforts around accountability, sustainability and transparency.
"Kids who are ages eight to 18 today the adults of 2020 will expect information instantaneously from shared digital networks, wordof-mouth and viral sources, social sites, smart phones or other devices."
MEATPOULTRY.com, October 07, 2008. Bryan Salvage.

Sanitation Program Divide

Legal Responsibilities
1.

Business Requirements Meet Business Plan Requirements Define Market and customer requirements Define your plan to meet 1 & 2 Measure and track the plan

2.

3. 4.

Compare your Policy & Programs to Government web sites and industry news
1.

Published law is the minimum standard Laws + Regulatory Guidelines + Industry norms = The Industry Standard 21 CFR 110 - Federal Law (1969)

2.

3.

Plant Standard = # 1 + # 2 + Customer Standards (AIB, Cook & Thurber, SQF, BRC, IFS)

FDA Home Page | CFSAN Home | Search/Subject Index | Q & A | Help

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL
PART 1 GENERAL ENFORCEMENT REGULATIONS

10.90 - Food and Drug Administration regulations, recommendations, and agreements

PART 11 PART 1405 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE

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FDA Home Page | CFSAN Home | Search/Subject Index | Q & A | Help

February 2008
Guidance for Industry

Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods

Draft Guidance Contains Nonbinding Recommendations III. Who Should Follow the Recommendations in this Guidance? We recommend that any processor of a RF-RTE food, including processors of fresh-cut fruits and vegetables, and processors of frozen fruits and vegetables, follow the recommendations in this guidance. Our recommendations apply regardless of whether or not the food that is processed supports the growth of L. monocytogenes. The fact that a food does not support the growth of L. monocytogenes does not affect a manufacturer's responsibility under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) to ensure that food is not prepared, packed, or held under insanitary conditions whereby it may become contaminated with filth, or whereby it may be rendered injurious to health.
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WA State WISHA Hazcom Laws

Develop, implement, maintain, and make available a written Chemical Hazard Communication Program Include multiemployer workplaces in your program if necessary Identify and list all the hazardous chemicals present in your workplace Obtain and maintain Material Safety Data Sheets (MSDS) for each hazardous chemical used Make sure that Material Safety Data Sheets (MSDS) are readily accessible to your employees and NIOSH Label containers holding hazardous chemicals Inform and train your employees about hazardous chemicals in your workplace Follow these rules for laboratories using hazardous chemicals Follow these rules for handling chemicals in factory sealed containers
WAC 296-800-17005
WAC 296-800-17007 WAC 296-800-17010 WAC 296-800-17015

WAC 296-800-17020
WAC 296-800-17025 WAC 296-800-17030 WAC 296-800-17035 WAC 296-800-17040

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Challenges: In our back yard

3 4

Plants Burned down Plant worker Deaths Juice, Lettuce, Spinach

Jack-n-Box

Cost per lb 2nd issue

E-Coli

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3

Food Plants closed

new Food Plants

Salmonella

Alfalfa Sprouts Tomatoes, Cantaloupe

Cow Disease Slaughter House

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Plants have changed ownership

Mad

Listeria

RTE Meat & Lettuce

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OLYMPIA - State health officials believe alfalfa sprouts are connected to an outbreak of Salmonella thats sickened nine people in our state and four in Oregon.
OLYMPIA - Nine cases of E. coli infection that have been lab-confirmed among western Washington residents may be linked to contaminated lettuce

OLYMPIA - Cantaloupe from Honduras has been implicated in dozens of illnesses across 16 states, including nine cases of salmonellosis in Washington.

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Listeria outbreak linked to Maple Leaf Foods

(MEATPOULTRY.com, August 25, 2008) by Bryan Salvage

OTTAWA Lab results from Health Canada established a link between meat products recalled by Maple Leaf Foods from a plant in Toronto and an outbreak of listeriosis in four Canadian provinces. The same strain has been detected in four people who have died and 21 cases of listeriosis have been confirmed to date. Thirty cases remain under investigation. Canadian federal health officials say there are 14 confirmed deaths from this countrywide Listeriosis outbreak linked to processed meats produced at the Maple Leaf plant in Toronto

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Plant Manger is Responsible

Plant Manger uses inputs from resources to define programs and establish plant policy

Corporate Directives Senior Management

QA/QC Production Engineering/Maintenance Sanitation Finance

Area Specific Supervisors

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Operational Plan
Policies Written procedures Work instructions Food Quality Plans Internal & external audits Security Plan Crisis Plan
Legal training requirements Raw Product control program Sanitation Program Food Safety & Security Plan HACCP Plan

Allergen Program
Pest Control Program Warehouse/recall Program

Corrective actions
Documentation Management

Third Party Verification

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If you do it, write it down!

If its not written down, it hasnt been done.

Be able to trace the plan Be able to correct the plan Be able to present the plan

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What is Sanitation? Perspective stock holder/consumer

1.

____________________________________
____________________________________ ____________________________________

2.

3.

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What is Sanitation?
Rob

Maintaining the Plant in a Clean Condition to minimize Risk. Required to make a saleable, revenue producing product

Don

Chris

An ongoing program that ensures the entire plant and grounds are maintained to ensure product integrity. The most important part of the Production Day

Margarito

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What is Sanitation? Perspective stock holder/consumer

Survey answers

Protects product integrity

A requirement by Federal Law A cleaning of the plant processing areas Insurance for Product Safety/guard against a recall Critical part of our production cycle Requirement to ensure safe food Assurance of quality for our customers Reduction of Risk

Sanitation is the integrity of my plant

Most unrecognized function in the plant

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The Weeds (details)

Production Purchasing Quality

HR

Sanitation

Maintenance

Employees Hazcom

Audits

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The Weeds (details)

Master Sanitation Crew Daily Sanitation

Usage

Audits

Work orders

Task Hazcom

Pre Op

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What is the plan?

Plan Name of ________ Purpose : Function and agreement Buy in statement / Explanation

1.

Whats in it for me? You? them? (WHY?) Because the auditor says so is not a reason. Your have an obligation to break the information down into usable form and obtain Buy in or conformity among the crew

Follow up - Measurement

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Definition of Sanitation

Sanitation

is the first step in the production cycle. Sanitation does not add value to a product which has just been manufactured it only protects the value of the product that will be produced. Sanitation Program is our second largest sales platform, right after the quality of our product
Jim Anderson

Our

Sanitation is the REDUCTION OF RISK as determined by plant management and implemented PLANT WIDE.

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Whats the plan?

1.

Define the parameters Validate the plan Verify the plan

2.

3.

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Validate & Verify (The Plan)

Training

Plan

Master

Sanitation Schedule usage plan

Chemical

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Validate & Verify

Training Training

Plan Legal Plan Business

The Topic, Need, Benefit, Justification The measurement Before, after, later Follow-up

Department
Personnel Refresher Does

Training plan

training plan Training

Training = Expectations?

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Validate & Verify

Master

Sanitation Schedule
Description Resp . P r o c . # D a i l y W e e k l y M o n t h l y Q u a r t e r l y A n n u a l l y Jan Feb Mar

Area

Item

Filler AreaBottle Line

Filler AreaCan Line Filler AreaBottle Line

Proportioning, Internal Cleaning and Carbonating Sanitizing (3 Step, 5 Step or and Filler 7 Step Dictated by Matrix) Equipment
Proportioning, Internal Cleaning and Carbonating Sanitizing (3 Step, 5 Step or and Filler 7 Step Dictated by Matrix) Equipment Proportioning, Carbonating External Foam Cleaning and and Filler Sanitizing of this Equipment Equipment

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Validate & Verify

Training

Plan The Topic, Need, Benefit, Justification The measurement Before, after, retention Follow-up Sanitation Schedule Product Contact 1st and 2nd level Environmental Procedural / SSOP Evaluation usage plan

Master

Chemical

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INVENTORY CONTROL
Inventory Period: 10/19/2008

Production Days in Period: Product

Caustic Acid Sanitizer

5 Actual Daily Usage

30.00 9.00 11.00

Size
300 gal
50 gal 55 gal

Begin Inven
300 100 55

Rec'd

Ending Inven
150

Used This Period

150 45 55

Net Price Gal/LB

$2.00 $4.00 $10.00

Survey Daily Usage

25.00 10.00 3.00

Usage Vari (+/-)

5.00 (1.00) 8.00

Actual Daily Cost

$60.00 $36.00 $110.00

Survey Daily Cost

$50.00 $40.00 $30.00

Cost Veri (+/-)

$10.00 -$4.00 $80.00

Days on Hand
5 18 5

110 55

165 55

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Inventory Control

Date: In Plant Inv = Ecolab Products Caustic Acid Sanitizer Pick Code 111 222 333 Unit Cont 1 55 50 $ $ $ Cost Unit 2.00 4.00 10.00 Start Inv 300 100 55 2 1 Amt. Rec.

Plant 1 Warehouse Full 50 1 1 Partial 22 Main Plant Full 90 1 Partial 25 37 25

Plant 2 Main Plant Full 13 Partial 70 45 25 Ending Inventory 270 192 100 Amount used 30.0 18.0 5.0

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Whats the Risk?

Start Program

use rate

Overuse $$

Underuse = Increased Risk

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How much chemical do I use?

Whats

the plan? Target use rates?

Legal requirement Sanitizers, Process aids Whats the limit? Plant target? Action if your above or below Legal limit? Action if your above or below Plant Target? Business requirement Cleaners above or below the plan, justify when you are outside of plan

___%

range.

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Cost Example 1
Chemical 1000 1 5

XYZ use rate is 5 oz/gal, $5.00/gallon

gallon circuit

gal = 128 oz oz/128 oz = .039 gallons x $5.00/gal = $.19 unit = 200 units x $.19 = $38.00

1000/5

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Cost Example 2 (10% increase)

Chemical
1000 1

XYZ use rate is 5 oz/gal, $5.50/gallon

gallon circuit

gal = 128 oz

oz/128 oz = .039 gallons x $5.50/gallon = $.21

= 200 units x $.21 = $42.00

1000/5

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Cost Example 3 (10% increase) (20% water reduction)

Chemical 800 1 5

XYZ use rate is 5 oz/gal, $5.50/gallon

gallon circuit

gal = 128 oz oz/128 oz = .039 gallons x $5.50/gallon = $.21

800/5

= 160 units x $.21 = $33.60

level = ($4.40) = (11%)

Savings 1st

Savings 2nd

level = Waste Treatment

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38

Food Safety Regulations

Early Beginnings
600

AD "He who deliberately gives or sells it (unfit food) to another will be banished for a year. If the person to whom it has been given or sold dies, the offender will be hanged"
T'ang Dynasty, China

??

"If dried or fresh meat causes illness, leftovers must be burned immediately. The producer will be flogged 90 strokes
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Education and Training

Competent Management to Produce Safe and Clean Food Training Programs for Food Handlers and Supervisors Responsible Persons Identified

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Sanitary Operations
Maintain Clean

Facilities and Equipment in a Clean Condition and Sanitize as Needed to Prevent Contamination

Keep

Cleaners and Sanitizers Free from Microorganisms

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Production and Process Controls

Validation Raw

- QC Microbial/Chemical/Extraneous-materials

Materials - Inspection/Segregated/Storage/Washing

Manufacturing Separation Control

Operations - Processing Time/Temp./pH/Flow/Pressure/etc. of Raw and Processed of Foreign Substances

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The SPIRIT of the LAW

GMPs

General Guidelines All Food Processors

Processors

Interpret Guidelines Develop Specific GMP Plan / Policy Implement Train Monitor

Responsibility

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SSOPs
Sanitation - Standard Operating Procedures

Required

Mega-Reg

by USDA - FISI a Prerequisite to HACCP

Considered Require

Effective GMPs

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SSOP Format
1. Date 2. Identification 3. Plant & Product ID 4. Management Structure SSOP Responsibility 5. Equipment Type 6. Cleaning Frequency

7. Procedure Including:

Preparation & Disassembly Cleaning & Sanitizing Reassembly

8. Monitoring Concentrations, Microbial, ATP 9. Corrective Action- Who & What & Verified? 10. Record Keeping
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SSOP Example

46

Good Manufacturing Practices - GMPs

Deadly

Consumer: People DIE Business: Lost Sales / Costly Recalls You: Plant Closes Safe / Quality Foods Safe Environment for:

Results

Everyones

Job - 100% Commitment

Food Production / Worker / The Environment -Earth

Make The Right Choice

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