QA at Two Roads: 0 to 60 in 2 years flat

Presentation to MBAA Summer Technical MeetingMiddlebury, VT August 8, 2015

Kendra Frederick, Ph.D. Director of Quality Assurance,

Two Roads Brewing Co - Stratford, CT

An Outline

1. Intro1. Two Roads’ story, challenges, strengths

2. Growth of QA 1. Focus2. Equipment3. Personnel

3. Current Focus / Testing4. Future

Setting the StageTwo Roads Brewing (TRB)

- Dual Business model: contract & own brand- Contract customers (13)- Large number of recipes (89 in 2014)- Numerous Yeast Strains (12 total; 7 in regular use)

- Rapid growth- Volume- # of recipes- Personnel

- Location- converted old factory next to train tracks; warehousing

outdoors- Lab space OK at first…quickly became small

Growth since inceptionYEAR

BBLSTRB

brandTotal

% growth – total

2012¹ 40 1002013 6,643 24,1962014 16,886 69,849 154%2015 25,000* 100,000* 34% *projected

BBLS

¹ Launched in Dec

ChallengesCan we slow down for a sec?

Rapid Growth – volume- Increasing testing throughput

- heavy reliance on technology/automation - Prioritizing testing

- Everything tested for micro- Some tests only every X batches, # packages- TRB brand-only tests: IBU, Color, Sensory

- Recipes (large #)- Takes a longer time to assess consistency, detect brand trends

ChallengesWhat’s your name again?

Rapid Growth – Personnel- Training

- Split & 3rd shift- Method creep- SOPs! (words vs pictures)

- Learning to Manage- Adjusting to supervising instead of doing- Learning to Trust someone else doing- I’m hands off…I hope you are too! - Agile Leadership

ChallengesWould you like fries with that?

Customers- Matching brand flavor across breweries- Communication

- One customer changed their yeast & forgot to tell us!- I’m 2 months behind on reports

- Numbers: just because it’s on the label, doesn’t mean it’s true- We’d hit target OG & FG…but ABV would be out of compliance

with label - Special requests

- >20 beers sent out for external testing for a single client

Strengths

- Funding- Start-up & subsequent phases have been well-funded- Debt OK if permits growth, improves quality, reduces risk

- Experience- Brewmaster 25 years, CEO & CMO >15 years each- Past negative experience w/ contract brewing = desire to do it right

- Support from Owners- Quality is important to Owners- Regional/National craft breweries serve as models

My background / philosophy- Education

- Degree in Biophysical Chemistry- Lots of pipetting!- Research, reading literature- Show me the Data

- Biopharmaceuticals- Product = Process- Documentation, SOPs- Cleanliness- Method development /

assay validation

QA = Quality Assurance- Preventative measures to ensure

quality- SOPs, Process Monitoring, Raw

material testing, Quality CCPs

QC = Quality Control- Measurements taken after the fact

to check for quality / prevent the release of inferior product

- Finished goods testing

HOW QA HAS GROWN at TRB

QA Focus

PROGRESSION1. Basic Data (gravity, pH), Micro, DO2. Compliance & package integrity (fill volumes, seam checks)3. Process Consistency (wort aeration, cell counts, sensory)4. Add capabilities (IBU, Color, Haze, ABV, sensory training)5. Reduce risk / time to test result (PCR, TPA)6. Shelf Life (TPA)

ALWAYS AT THE FOREFRONTA. Throughput (digital meters, automation, filtration manifold)B. Precision (digital, automation)C. Documentation

Equipment - growth

Approx DateApprox

Annualized BBLS

Instruments Use

Start-up Dec 2012:

Getting off the ground

n/a

• Microscope• pH meter• Hydrometers• Scale• Laminar Flow Hood• Micropipettors• ATP swabs / luminometer

Basic measurements, micro

• Automated Cell counter (Nucleocounter)

Yeast counts & viability

• Dissolved Oxygen Meter + package piercer DO, TPO

Equipment - growth

Approx DateApprox

Annualized BBLS

Instruments Use

early 2013:Increasing throughput

15,000

• Handheld density meter (Anton Paar DMA 35)

Increase throughput / precision of gravity measurements

• Filtration Manifold* Increase throughput of micro testing

• Headspace airs tester (Zahm-Nagel) TPO

Equipment - growth

Approx DateApprox

Annualized BBLS

Instruments Use

late 2013 – early 2014:Increase

capabilities, consistency

24,000

• Seam Check equipment* Package integrity

• High-range DO meter Wort aeration

• UV-Vis IBU, Color, et al

*at recommendation of Packaging Manager

Equipment - growth

Approx DateApprox

Annualized BBLS

Instruments Use

Mid 2014:Increase

capabilities, throughput, reduce risk

50,000

• PCR equipment* Rapid detection of micro contamination

• 2nd handheld DMA Increase throughput of gravity measurements

• Alcolyzer ABV, density

*decision driven by need to supply timely results to contract customers; got a good deal on instrument

Equipment - growth

Approx DateApprox

Annualized BBLS

Instruments Use

Late 2014:Increase

capabilities, precision /

consistency

70,000

• Turbidity meter* Haze

• Cell counter (Cellometer)

Improve precision / accuracy of cell counts. Add capabilities (vitality)

• Digital carbonation tester (CboxQC) CO2, DO

Mid 2015Increase

capabilities, thruput

90,000• Total Package

analyzer (Hach Orbisphere)*

TPO

*purchase driven by issue with particular contract brand & desire to match measurements across 2 sites

Lab Growth: PersonnelDate

Approx Annual BBLS

# Empl.

BBLS / Employee

before -- after new hire

Notes

11/12 01

0

06/13 17,28017,280 Intern ~10 hrs/wk starting 03/13

28,640

09/14 50,40025,200 Intern ~10 hrs/wk starting 09/13

316,800

12/14 56,34818,763

3.516,100 0.5 FTE dedicated to sensory

07/15 90,93325,981

4.75 19,144 A real QA Department!

CURRENT STATE OF QA at TRB

Current brewery set-up- Brewhouse:

- 100-bbl, 4 pieces- Fermentor Tanks: 34, >200k capacity

- 12 x 100-bbl- 18 x 300-bbl- 4 x 600-bbl (new as of 06/12)

- Yeast Brinks: 4 x 15-bbl - Centrifuge: HP2 GEA (150 bbl/hr)

- Brite Tanks:- 1 x 50-bbl- 2 x 100-bbl- 1 x 200-bbl- 3 x 300-bbl

- Bottle Filler- 40-head, 300 bpm

(750 cases/hr)- Formats: Heritage, long-neck, 22-

oz, 375-mL, 750-mL- Crown, cork & cage

- Can filler- 32-head, 280 bpm

(700 cases/hr)- 12-oz & 16-oz- High-cone; 4-, 6-, 12-pack wraps

- Keg line- 1 keg/min (60 kegs / hr)- 4-station

ShiftsBrew: 24/5

Package: 12/5

Current Quality Focus minor

major

x

Kegging

xCentrifuge

Micro testingFermentation Bright Tank Packaged

Beer Yeast

Timing: 24 -72 hours post-KO

once per week

2 from each run; >12-24 hrs

post-fill

When harvested to

brink

Media

LMDA+ / aero X X Every 3rd New propWLD / anaero X X Every 3rd New prop

NBB X X X New propLCSM¹ X 1/wk New prop

LWYM¹,² X 1/wk New propWLN XRDM³ X

In case of positive:

Retest at 5-7 days

PCR on package

Retest if BS; PCR if NBB is

posWLN: test beer;

dump yeast

¹Saisons not tested²Hefs not tested³YPD + TTC overlay

BS = beer spoiler

Micro

“Clean room” was an old bathroom…so hood was a must!

Yeast Testing

Strain cross-contamination:- Currently: Plate on WLN 4-5 days.

Look for colony homogeneity- Coming soon: PCR assay?!

Ale Lager French Saison

Micro: PCR- Real-time PCR thermocycler (AB

StepOne Plus)- Kits available to detect Lacto/Pedio

and Dekkera- Sensitive enough to detect after 1-2

days of pre-incubation- “Open source”: can develop own

assay- Currently collaborating to develop assay

to detect yeast cross-contamination

*PCR = Polymerase Chain Reaction; detect DNA from target organism / gene

Cell CountsPreviously: Nucleocounter- Cassettes – expensive. Images: low resolution. No

opportunity to manually adjust counts

Now: Nexcelom Cellometer- Higher magnification, brightfield image,

manual adjustment possible, several “staining” options including vitality.- Required fair degree of method

development & user training (pipetting!)

Finished Beer TestingFinished Beer Testing Package Testing

Test Frequency Test Frequency

Gravity Every batch TPO Every run

pH Every batch Fill Volume Verification

Every TRB; contract: > every

4000 casesABV Every batch Carbonation Occasionally

Haze Nearly every batch Seam Check At least every

4000 casesColor TRB onlyIBU TRB only

UV-Vis Spectrophotometer

Turbidimeter

Phys-Chem

Orbital shaker for IBU sample prep

Seam Check Equipment

Date

Adjustment

Alcolyzer- Have had issues keeping in

“calibration” from the get-go.- We use to perform daily

gravity checks. Requires more vigorous cleaning, but worth it.

- Peristaltic pump broke. Service tech of 17 years had never seen one break.

Dissolved Gasseso-DGM

- DO into/out of centrifuge

Previously:- DO in BT’s- DO in packages

CboxQC- Carb & DO in

BT’s- Required

significant training, despite seeming simple to use!

Our Newest Toy: TPO analyzer

- Broke within the first week!

Other Testing- ATP swab (after every CIP)- Water testing (weekly)- Swabs on fillers- Sieve testing of grist (as “needed”)

Data Management- Lots of work / attention / time devoted to

documentation- measurements, volumes, dates/times, etc

- Series of Excel spreadsheets “linked” via Macros (saving, copying / pasting automated)

- Leveraging Dropbox to share data/files with customers

- Will investigate more elegant data management solution in 2016

Data Management

Primary Sources List of all filesAlcolyzer/DMA output Alcolyzer - data manipulationsIBU/Color data files Batch List - 2015Control Room Sheet Yeast TrackingDO log QA Batch DataBatch List Log Book - reportsFill Volume data files (CRS) Data Grab MacroMicro monthly log files IBU & Color - TemplateWeekly Data Sheet Micro Summary

QA Batch DataQA Batch Data

Data ManagementPrimary Data Primary Source Data Transfer 1-->2.1 Secondary

Destination 1

Density, ABV, FG Alcolyzer/DMA outputcopy raw data to 'Alcolyzer - data manipulations' file. Then use macros to export to 2 dest

QA Batch Data

Package Date Batch List use macro in 2 dest to pull from 1°CRS Batch Sheet - Testing tab

Cell Counts Control Room Sheet use macro in 2 dest to pull from 1° Yeast Tracking SheetOG, pH Control Room Sheet use macro in 2 dest to pull from 1° QA Batch Data

Brew Date,Sep Date

Control Room Sheetues 'Log Book - reports' macro to generate report; copy manually into 2 / auto copy to 2

Batch List

Dry hop date Control Room Sheet formulas in-fileCRS Batch Sheet - Testing tab

DO - BT Control Room Sheet **need procedure DO data log

Carbonation Control Room Sheet formulas in-file / manualCRS Batch Sheet - Testing tab

TPO - PKG DO log use macro in 2 dest to pull from 1°CRS Batch Sheet - Testing tab

Fill Volumes Fill Volume data files **need procedureCRS Batch Sheet - Testing tab

IBU, Color IBU/Color data files macro in 1 sends data to 2° QA Batch Data

Final pH Weekly Data Sheet manual QA Batch Data

Micro Micro monthly log files manualCRS Batch Sheet - Testing tab

Haze Weekly Data Sheet manual QA Batch Data

SensoryA work in progress…

- Began formal sessions in March 2013- Differing visions for how to approach, begin, conduct sensory

- Me: start with training. Others: dive right into descriptive analysis- Different groups with different goals/needs

- Brewers/Cellar: Off-flavors in wort, green beer, and finished beer- Sensory Panel: trueness to brand, off-flavors in finished beer- Sales – Internal: brand recognition, off-flavors in the “field” (oxidation,

dirty lines)- Sales – External: as above, plus “Cicerone” (general beer IQ)

SensoryStruggles…

- Schedules: “9-5’ers”, 2nd& 3rd shift, sales- Attendance

- 11am ideal palate-wise, but we’ve found mid to late afternoon better schedule-wise

- Lots of management “too busy” for sensory- Space

- (currently) No dedicated sensory space. Use event room, second bar, meeting room.

SensoryA compromise…

- 2 sessions a week, focusing on consistency & stability of TRB brands. Occasional trainings & external comparisons

- Brand Attribute forms – to guide tasters.- Brand-specific list of desirable (or not) attributes + target strength.

SensoryRighting the course…

- Hired a dedicated employee for sensory! (0.5 FTE)- More availability to accommodate different groups’ schedules

- Training- Flavor Recognition: Using Sigma & Aroxa spikes- Sales: 3 sessions so far, seeing progress (!), giving them ideas - Brewers & General Panel getting trained as well.

- Methods:- Introducing & using triangle

- Space- Coming soon!

THE FUTURE

Expansion!

+

QA Focus1. Basic Data (gravity, pH), Micro, DO2. Compliance & package integrity (fill volumes, seam checks)3. Process Consistency (wort aeration, cell counts, sensory)4. Add capabilities (IBU, Color, Haze, ABV, sensory training)5. Reduce risk / time to test result (PCR, TPA)6. Sensory (trained & validated panel!)7. Kegs 8. Shelf Life (TBARS, TPO, chill haze)9. Consistency (wort & green beer IBU & color, GC)10.Raw Materials