Incorporating Food Safety

Responsibilities into a Quality Program

11/9/2018

Links to all resources covered:

Quality Priority Pyramid

Good Manufacturing Practices for Craft Brewers

Food Safety Plan for Craft Brewers

Voluntary Market Withdrawals and Recalls

FSMA FAQs

Quality Subcommittee

Formed in 2014

• Jason Perkins, Allagash Brewing

• Alastair Pringle, Pringle-Scott LLC

• Jamie Floyd, Ninkasi Brewing

• Larry Horwitz, Four String Brewing

• Neil Witte, Brewers Association

• Phil Leinhart, Ommegang

• Rob Christiansen, New Belgium Brewing

• Tom Flores, Brewer's Alley

• Tom Shellhammer, Oregon State

• John Mallett, Bell’s Brewing

• Ken Grossman, Sierra Nevada

Quality Subcommittee Members

Foundational documents for the BA Quality Subcommittee

Quality Beer: A beer that is responsibly produced using wholesome ingredients, consistent brewing techniques and good manufacturing practices, which exhibits flavor characteristics that are consistently aligned with both the brewer’s and beer drinker’s expectations.

Vision: Our vision is a membership that consistently produces beer of high quality.

We seek to continue the advancement of quality within the craft brewing community through:

• Fostering a sense of shared responsibility in all breweries for the importance of quality in craft beer

• Motivating all BA members to invest in issues that improve and maintain quality, without compromising their focus on creativity and flavor

• Educating all BA members about existing quality resources and best practices for ingredient selection, process control

Quality Subcommittee Mission Statement:

The Quality Priority Pyramid

Alastair Pringle – Pringle-Scott LLC

Originated from early discussions about quality by the Beer Quality Sub-group

Provides: • A road map for the development of materials addressing the different

aspects of quality

• An effective way of communicating priorities for addressing quality

Has evolved with changes in regulations and as the subcommittee's thinking evolved

History of the Pyramid

Summarizes the elements of a

quality program

Provides a means for brewers

to prioritize their efforts • e.g. GMPs should be first item

you tackle so you are ready for

an FDA audit

What it does:

What it isn’t:

It is not a strict, step by step

process.

You can work on other areas at

the same.

Version 2.0:

GMPs• Good Manufacturing Practices

for Craft Brewers

• Check-lists available on BA

website

• Being used by some states for

audits

Version 2.0:Food Safety

HACCP

• Currently not required by FDA

• Methodology can help prevent recalls

• There is a resource for this on the BA website

Preventive Controls• Currently not required by FDA

• A modification of HACCP that focuses on

prevention

• Required for facilities producing non-alcoholic

drinks

• Resource on this coming soon

Version 2.0:Process Controls

Consistent beer flavor, color, alcohol

content, etc. can be achieved

through:

• Identification of quality control

points (QCPs)

• Then, control of the QCPs

Version 2.0:Standards

Develop standards for: • Finished beer

• Beer production processes

Includes establishing SOPs for:• Process procedures

• Cleaning and sanitation procedures

• Laboratory procedures

Version 2.0:Analysis

Perform chemical, physical, and

sensory analyses to routinely to

verify:• Process control

• Product parameters are within set

standards

• Product shelf life and stability

Version 2.0:

Continuous Improvement• Continually look for ways to improve the

product and the process

Preventative maintenance• Reduce down time

• Improve product quality

Good Manufacturing Practices (GMPs) for

Craft Brewers (GMPCBs)

Phil Leinhart – Brewery Ommegang

Background of The Food Safety Modernization Act (FSMA)…

• The Food Safety Modernization Act (FSMA) was signed into law in 2011.

• FSMA specifically defined alcoholic beverages as food and for the first time brought alcoholic beverage producers under direct FDA regulation, without affecting TTB authority.

• Alcoholic beverage producers are exempt from several portions of FSMA but do need to comply with other portions regardless of size.

• Compliance with Good Manufacturing Practices (GMP’s) is one of those portions.

• GMP’s have historically applied to the Food Industry such as Dairies and Meat Processing facilities.

• Current FDA regulations require all breweries to have an active GMP program in place. Failure to meet this requirement could result in several disciplinary actions.

…and it’s application to alcoholic beverage producers…

• Good Manufacturing Practices for Craft Brewers (GMPCB’s) were adapted from GMP’s but apply more specifically to conditions and operations inside a brewery.

• GMPCB’s are essentially a set of standards used to determine if a brewery is maintaining practices set by federal, state and county regulations.

• They are the foundation for all quality, food safety and organizational initiatives in any brewery.

• They establish clear guidelines for the hygiene and cleanliness of the workers and the brewery.

• They dramatically decrease food safety risks for the brewery’s customers.

• They are easy to execute and maintain.

…including breweries.

• Compliance with the Standards are addressed through a series of checklists addressing the following topics:

• Plants and Grounds

• Equipment and Utensils

• Sanitary Facilities and Controls

• Sanitary Operations

• Processes and Controls

• Personnel

Food Safety Plan for Craft Brewers

Jamie Floyd – Ninkasi Brewing Co.

What is the document?

The Quality Subcommittee created this document which provides templates that focus on a particular type of hazard and includes some control measures that can

be implemented.

Where is the document?

https://www.brewersassociation.org/best-practices/quality/food-safety-plan-for-craft-brewers/

The templates are customizable to fit each brewery’s complexity.

Each template addresses a different kind of hazard and includes control measures that can be implemented.

Though not HACCP specific, these pull from HACCP theory

The Food Safety Plan for Craft

Brewers is meant to be an

extension of the GMPs for

Craft Brewers with a focus on

preventative controls through

Hazard Assessment throughout

the brewery.

Templates cover:

• Allergenic Ingredients

• Chemical Inclusion

• Hazardous Object Inclusion

• Package Explosion

• Toxicants

• Revision Log

High level points about FSMA from Tatiana Lorca PHD of Ecolab. She has extensive HACCP and Food Safety background

Beer is food and food is regulated by the U.S. Food & Drug Administration.

Breweries are not exempt from protecting their customers and meeting food safety requirements.

Whether you have to comply with FSMA depends on who your customer is.

Suggestions from Tatiana Lorca of Ecolab:

Tatiana and Doug Hindman did an awesome talk at the 2018 CBC on FSMA and what it means to brewers.

You will be inspected. The inspector may come from the FDA, the Health Department, the Department of Agriculture or it may be your customer or a designate

The different Rules within FSMA will tell you what the minimum requirements are which apply to your business.

The MBAA Food Safety Committee is putting together their plan to teach 3 district level HACCP for Brewers courses in 2019. The

What Audits are finding at breweries from Doug Hindman, Brewery Ops Manager at Elliott Bay Brewing, MBAA District NW Vice President

Keep exterior doors closed (pest management)

Keep glassware and food out of areas where product is handled

Hair restraint (caps/beard nets) use when ingredients/processing aids/product is exposed

Properly store, label, and track removal of spent grain

SOPs clearly spelled out and signed off after training

Validate CIPs and maintain supporting document trail

No cats in the brewery substituting for "real" pest control

Suggestion from Doug Hindman Elliott Bay Brewing

Voluntary Market Withdrawals and

RecallsGuidance for Craft Brewers

Larry Horwitz – Four String Brewing Co.

We strive to make the best, safest beer possible

Mistakes can and do occur

It is the brewer’s responsibility to ensure removal of the product from the market before harm is caused to the consumer.

Withdrawal MAY be for non-safety reasons

But what if we made an error and think we need to recall?

FSMA/GMP

• FDA, under the mandate of FSMA, is responsible for the

regulation and food safety standards for most of the U.S.

food supply.

• FDA has authority to force a recall and shut down

operations at breweries if there is a significant threat to

public health.

• Recalls are classified according to their potential

seriousness.

Major Reasons for Recall or Withdrawal

• Misbranded or mislabeled beer

• Foreign object inclusion: plastic, glass or metal fragments. Etc.

• Chemical contamination

• Allergens or other toxins in the beer

• Package over-pressurization

Contamination

Adulteration

Misbranding

What to do if You Have an Issue

Notify the TTB• File a Notice of Intent with the TTB

before destroying beer

• TTB may communicate with FDA

Courtesy call FDA• They monitor, and don’t like to be

surprised.

Contact stake holders and

remove your product from the

market

Hopefully you have date / lot codes!

Avoid the Expense and Stigma – Have a Recall Plan

Plan to make life less painful

• Follow the Date and Lot Coding Best Practice

• Keep and test a library of packaged beer

• Assemble an internal consumer safety team to identity

hazards. Use:

• BA’s Food Safety

• GMPs for Craft Brewers resources.

• Develop a recall plan and practice it

• Implement at least a basic microbiological screening

program

• Best practice is annual mock recall