Internal Auditor

2 day course

CASE STUDY
 Dairy Made
Case Study

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EXERCISE

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 Case Study Contents
1 General information .................................................................................................. 3
2 Site description ......................................................................................................... 3
3 Operations.................................................................................................................. 4
4 Finished product and raw materials ........................................................................ 5
5 Production processes ............................................................................................... 6
6 Dairy Made - organisation chart ............................................................................... 8
7 Management review – Procedure 1 ......................................................................... 9
Objective...................................................................................................................... 9
Responsibility .............................................................................................................. 9
Scope .......................................................................................................................... 9
Terms of reference ...................................................................................................... 9
Management review process ....................................................................................... 9
Management review report ........................................................................................ 10
8 Purchasing – Procedure 2 ...................................................................................... 11
Scope ........................................................................................................................ 11
Responsibility ............................................................................................................ 11
Purchasing authority .................................................................................................. 11
Supplier approval ....................................................................................................... 11
Purchasing................................................................................................................. 12
Monitoring of suppliers............................................................................................... 12
Emergency purchases from non-approved suppliers ................................................ 12
9 Housekeeping and Hygiene – Procedure 3........................................................... 13
Scope ........................................................................................................................ 13
Responsibility ............................................................................................................ 13
Materials .................................................................................................................... 13
Hazards ..................................................................................................................... 13
Dismantle Instructions ............................................................................................... 14
Cleaning and sterilisation of machine parts ............................................................... 15
Cleaning and sterilisation of machine and line........................................................... 15
Cleaning verification .................................................................................................. 15
Recordkeeping .......................................................................................................... 16

Issue 3 Dairy Made Case Study Page 2

1 General information
Dairy Made is a private, family-run business that was established in 1960. The company originally
started as an ice cream parlour, making ice creams in a small kitchen at the back of the shop. It has
grown significantly since then and the site, based in Coolville, now manufactures ice creams and frozen
yoghurts. These are sold in 4 litre, 1 litre, 500ml and single-portion tubs (boxes of 12), to retail and
foodservice outlets. The company also buys in cones and ice cream toppings to sell on to their
foodservice customers.

2 Site description
The site was built 5 years ago, and has an internal area of 5000m3. New plant and equipment was
installed at the time, including a heat plate exchanger, Diessel mixers and a CIP (cleaning in place) set.

Issue 3 Dairy Made Case Study Page 3

3 Operations
The site operates 24 hours a day, 7 days a week. The company employs 243 staff (full-time equivalent).

Production and cleaning staff work 12 hour shifts, 4 days on, 4 days off. The 6am – 6pm shift team are
production staff, whilst the 6pm – 6am shift do a full clean and sanitisation of the production areas.

Issue 3 Dairy Made Case Study Page 4

4 Finished product and raw materials

Product Pack sizes

Madagascan Vanilla ice cream 4 litre (catering pack), 1 litre, 500ml, 12 x 180ml
Strawberries & Cream ice cream 4 litre, 1 litre, 500ml, 12 x 180ml
Belgian Chocolate ice cream 4 litre, 1 litre, 500ml, 12 x 180ml
Chocolate Brownie ice cream 4 litre, 1 litre, 500ml
Pistachio ice cream 4 litre, 1 litre, 500ml
Lemon Cheesecake ice cream 4 litre, 1 litre, 500ml
Sicilian Lemon frozen yoghurt 1 litre, 500ml
Honey & Nut frozen yoghurt 1 litre, 500ml
Madagascan Vanilla yoghurt 1 litre, 500ml

Traded products Pack sizes

Wafer cones Packs of 20, 50 and 200
Waffle cones Packs of 20, 50 and 200
Chocolate sauce 325g, 600g
Strawberry sauce 325g, 600g
Toffee sauce 325g, 600g
Dark Chocolate vermicelli (sprinkles) 500g, 1kg
Milk chocolate vermicelli (sprinkles) 500g, 1kg
White chocolate vermicelli (sprinkles) 500g, 1kg

Raw materials
Pallecons (1 tonne) 10kg buckets
Milk (4% fat) Pasteurised whole liquid egg
Double Cream (48% fat) Cheesecake base
Whipping Cream (19% fat)
1 tonne pressurised tanks
25kg sacks Chocolate ripple sauce
Fruit conserves (strawberry, Sicilian lemon)
Granulated sugar
Honey
Demerara sugar
Skimmed milk powder
Packaging items
Cocoa powder
Dark chocolate chips 180ml & 500ml card pots
Stabiliser blend 180ml & 500ml card lids
Chocolate brownies 12mm 1 litre & 4 litre plastic pots
Hazelnuts 1 litre & 4 litre plastic lids
Roasted almonds Film lids
Pistachio nuts Corrugate outers
Sealing tape for outers
Pallet wrap
Outer case labels

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5 Production processes
Process step 1
 Raw material intake - into ambient, chilled and frozen
stores.
 Allergen-containing ingredients (supplied with orange
labels) separated and racking labelled with orange stickers.
 Ambient inclusions, such as chocolate brownie pieces, are
frozen so that when they are added into the ice cream they
do not raise the temperature of the mix and cause quality
issues.

Process step 2
 Milk and cream are supplied in plastic-lined pallecons
(reusable steel folding bag-in-box bulk containers for the
packaging of non-hazardous liquid products) and stored in
chillers.
 Pallecons can be connected to the mixers and the
milk/cream pumped through for processing.

Process step 3
 White base mixes are made up according to recipes and
pasteurised in a heat plate exchanger.
 These are then sent through to aging tanks for the aging
process, which takes up to 17 hours. The temperature of
the mix is held at approximately 5°C.
 The mix is then pumped through to the Diessel mixers in
the high risk area.

Process step 4
 Additional mixes or inclusions for the ice creams are de-
boxed and sent through in their plastic wrapping via a
sanitising bath.
 They are held submerged in the sanitising solution for two
minutes before the cage is released.

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 Process step 5
 White bases and any additional ingredients (e.g.,
cheesecake mix, yoghurt, lemon sauce) are pumped into
the Diessel mixers.
 The mixture is then taken across to the ice cream freezers
in vessels.

Process step 6
 The ice cream base is aerated and frozen to -5°C. After
freezing, it is mixed with other sauces or inclusions (e.g.,
ripple sauce, chocolate brownie pieces) when deposited
into tubs.

Process step 7
 3D barcode scanners check the packaging is correct.

Process step 8
 The ice cream tubs are passed through the metal detector,
which is fitted with a reject bin at the side.
 Tubs go through to the spiral freezer, which brings the
temperature down to -18°C hardening the ice cream before
being packed into boxes and stored in the dispatch
freezers.

Issue 3 Dairy Made Case Study Page 7

6 Dairy Made - organisation chart

Issue 3 Dairy Made Case Study Page 8

7 Management review – Procedure 1
Read through the following management review procedure in preparation to undertake a live audit (role
play). Delegates will be asked to play the role of auditor and evaluate the management review
procedure, Dairy Made records, and auditee responses against the requirements of section 1.1 and
clause 1.1.3 of the BRC Food Safety Standard Issue 7. Your trainer will guide you in completion of this
exercise.

Procedure Title: Management review Procedure No: OP001 Version No: 01

Approved By: Elena Gatti Issue date: 15.01.15 Page No: 1 of 2

Objective
The objective of the management review is to assess Dairy Made’s Food Safety and Quality
Management System (FSQMS) against the site’s food safety and quality objectives and requirements of
the BRC Global Standard for Food Safety.

Responsibility
Site Directors are responsible for initiating and completing the management review process every six (6)
months. The Managing Director is responsible for approving the management review report, meeting
outcomes, and allocating resources to implement action plans. Site directors are responsible for
communicting meeting outcomes, corrective and/or preventive action plans, and timescales to relevant
staff. Site directors are responsible for tracking action plans through completion.

Scope
The management review process shall evaluate and make recommendations on the following:
• Previous management review action plans, timescales, and completion status
• Food safety and quality objectives
• Audit results
• Customer complaints
• HACCP plan, food defense and food authenticity system reviews
• Incidents
• Corrective actions and non-conforming material and/or finished product
• Resource needs

Terms of reference
Key Performance Indicator (KPI) = A process characteristic identified by the management team
that can be used to measure hygiene standards, business efficiency and customer satisfaction.

Site Directors = Managing Director, Finance Director, Sales Director, Human Resources Director,
and Operations Director

Management review process

Establishing, analysing, and commuicating KPI’s for food safety and quality objectives.
a. KPI’s and targets are agreed to by site directors in January of each year and recorded
in the KPI register.
b. KPI data are collected, trended monthly, and reported in a standardized format for
review at monthly senior management and 6 month management review meetings.

Issue 3 Dairy Made Case Study Page 9

 Procedure Title: Management review Procedure No: OP001 Version No: 01
Approved By: Elena Gatti Issue date: 15.01.15 Page No: 2 of 2

c. Corrective action plans and timescales are developed and implemented where KPI
data does not meet performance target.
d. Monthly KPI results are posted on staff notice boards.
Evaluating audit results
a. Internal, second, and third party audit reports of the site shall be reviewed for
conformance, non-conformance (NC) and opportunities for improvement (OFI).
b. Corrective and preventive action plans for audit NC’s and OFI’s shall be reviewed and
assessed for completion and continued implementation.
Evaluating customer complaints
a. Customer complaints shall be summarized and trended. Recommendations to reduce
identified trends shall be discussed.
Evaluating food safety system reviews
a. Reviews of the HACCP plan, food defense, and food authenticity systems shall be
evaluated for areas of risk and vulnerability.
Evaluating corrective action and non-conforming product
a. Non-conforming materials or finished product shall be summarized and trended.
Associated corrective actions shall be reviewed and assessed for completion and
continued implementation. Recommendations to reduce non-conforming material or
product trends shall be discussed.
Identifying resource needs
a. Personnel, equipment, or other resource needs shall be identified and evaluated for
approval.

Management review report

The Management review report shall include the following:
• Summary of items reviewed (should include all items listed in scope)
• Improvements for achieving food safety and quality objectives and for increasing the
effectiveness of the FSQMS
• Improvements for conformance to the BRC Global Standard for Food Safety issue 7
• Summary of corrective and preventive actions with timescales for completion
The Management review report, action plans, and resource needs are approved by the
Managing Director.
Management review records shall be maintained according to the site’s record retention
policy.

Change Log

Version Date Changes

01 15.01.15 First issue; no amendments.

Issue 3 Dairy Made Case Study Page 10

8 Purchasing – Procedure 2
Read through the following Purchasing procedure in preparation to undertake a live audit (role play).
Delegates will be asked to play the role of auditor and evaluate the supplier approval and purchasing
procedure, Dairy Made records, and auditee responses against the requirements of section 3.5 of the
BRC Food Safety Standard Issue 7. Your trainer will guide you in completion of this exercise.

Procedure Title: Supplier approval and

Procedure No: OP002 Version No: 02
purchasing
Approved By: Paola Gatti Issue date: 10.1.15 Page No: 1 of 2

Scope
This procedure details the method for approving suppliers, purchasing goods, monitoring supplier
perforamance, and emergency purchases from non-approved suppliers.

Responsibility
Finance Director has overall responsibility for purchasing budgets and ensuring Managers keep
within budget.
Technical Manager is responsible for approving new suppliers verifying supplier monitoring.
Customer Services Manager is responsible for monthly evaluation of suppliers.
Account Manager is responsible for ensuring all purchase orders are issued for all purchases.
Production Manager is responsible for ensuring that only approved supplier materials are used.

Purchasing authority
Managing Director Unlimited
Finance Director Up to £5000.00
Managers Up to £1000.00

Supplier approval
All raw materials and packaging shall be evaluated for risk to product safety and quality
and purchased from approved suppliers.
a. Requests for new raw materials/ packaging or materials/ packaging from a new
supplier shall be made on the New Material Request Form (Ref F025) and forwarded
to the Technical Manager for evaluation.
The Technical Manager shall conduct a risk assessment for all new materials and
packaging according to the Material Risk Assessment Questionnaire (Ref F027) and
record findings.
a. Based upon the nature of the material risk assessment results, the Technical Manager
shall categorize the material as high or low risk.
The Technical Manager shall provide new suppliers with the New Supplier Questionnaire
(Ref F026) form for self-evaluation.
a. Suppliers of low-risk materials shall be approved based upon successful completion of
the questionnaire.

Issue 3 Dairy Made Case Study Page 11

 Procedure Title: Supplier approval and
Procedure No: OP002 Version No: 02
purchasing
Approved By: Paola Gatti Issue date: 10.1.15 Page No: 2 of 2

b. Suppliers of high-risk materials shall be approved based upon successful completion

of the questionnaire and current certification to a GFSI benchmarked scheme. Where
the supplier is not certified to a GFSI benchmarked scheme, approval cannot be
granted until successful completion of an on-site food safety audit by Dairy Made’s
approved auditing firm.
c. The Technical Manager shall record supplier approval status in the BuyIt
Computerized purchasing system.

Purchasing
All raw materials and packaging must be purchased from an approved supplier.
Emergency purchases of materials from non-approved may be considered according to
emergency purchase criteria described below. Other goods and services may be
purchased at the discretion of the purchasing manager.
For each purchase, the Account Manager shall issue a Purchase Order through the BuyIt
computerized purchasing system detailing the following:
• Price
• Quantity
• Specification
• Delivery date
• Contact name

Monitoring of suppliers
On a monthly basis, the Customer Services Manager generates a Supplier Performance
Report from the BuyIt computerized purchasing system monitoring supplier performance
against the following criteria:
• On time delivery
• Certificate of Analysis (COA) or Certificate of Conformance (COC) with shipment
• Material non-conformance from in-house analysis and use

Emergency purchases from non-approved suppliers

Emergency purchases of raw materials and packaging from non-approved suppliers may
be made where all of the following conditions apply:
a. Emergency purchase is a single purchase and not recurring.
b. Supplier is currently certified against a GFSI benchmarked scheme
c. Statistical lot sampling is conducted and samples are analysed for relevant hazards or
purity characteristics as described on the Material Risk Assessment Questionnaire.
The Finance Director and Technical Manager are dually responsible for evaluating and
approving emergency purchases from non-approved suppliers.
Change Log

Version Date Changes

02 10.01.15 Purchasing authority added.

Issue 3 Dairy Made Case Study Page 12

9 Housekeeping and Hygiene – Procedure 3
Read through the following cleaning and sanitation procedure in preparation to undertake a live audit
(role play). Delegates will be asked to play the role of auditor and evaluate Sanitation Standard
Operating Procedure – Machine 37, Dairy Made records, and auditee responses against the
requirements of section 4.11 of the BRC Food Safety Standard Issue 7. Your trainer will guide you in
completion of this exercise.

Procedure Title: Sanitation Standard

Procedure No: SSOP37 Version No: 01
Operating Procedure – Machine 37
Approved By: Ally Sheedy Issue date: 25.01.15 Page No: 1 of 4

Scope
This procedure details how to dismantle, clean, sanitise, and verify cleanliness of Machine 37
following a day of production.

Responsibility
The Hygiene Manager is responsible for ensuring all staff performing this task are trained and
evaluated for competency on the following procedures. Training activities shall be documented on
the Sanitation Training Log (Ref F009).
SSOP01 – General Cleaning Procedures
SSOP02 – Chemical Use, Labeling, and Storage
SSOP03 – Cleaning Equipment and Color Coding
SSOP37 – Machine 37
Cleaning supervisors are responsible for ensuring cleaning operatives work according to site
procedures and verifying cleaning records.

Materials
Chemicals
• Alco wipes
• Powerklenz - 1.5% (Liquid detergent)
• Steriklenz 5 - 1.0% (Foaming no rinse QAC disinfectant)
Cleaning equipment
• Disposable scouring pads
• Foam dispenser
• White brushes (food contact surfaces)
• Yellow brushes (non-food contact surfaces)
Personal protective equipment (PPE)
• Chemical resistant apron or overalls
• Chemical resistant gloves
• Goggles
• Slip and chemical resistant boots
Hazards
Refer to chemical Material Safety Data Sheets (MSDS) for specific hazards.

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 Procedure Title: Sanitation Standard
Procedure No: SSOP37 Version No: 01
Operating Procedure – Machine 37
Approved By: Ally Sheedy Issue date: 25.01.15 Page No: 2 of 4

Dismantle Instructions
Dismantle Machine 37 according to instructions below.

Step 1
Remove Rinse hopper, pipework, and filler before dismantling
product and cleaning to remove the bulk of product residue.
residue

Step 2
Dismantle Disconnect the air line from the demand valve. Remove
demand the 4 bolts and the direction indication pointer.
valve Do not steam sterilise valve body.

Step 3
Disconnect all product pipework and vent pipework
Dismantle starting at the lowest level and working back towards
pipework the hopper.

Step 4 Disconnect the probe from the electric plug, remove,

Dismantle clean thoroughly and store in the red box above the
probe utility sink.

Step 5 Remove the hopper lid by loosening the wing nuts that
secure it in place. Inspect the hopper seal upon
Dismantle removing the lid and report damage to your Supervisor
hopper immediately. Remove the hopper by undoing the 3
retaining bolts.

Step 6a Disconnect the four airline fittings associated with the

Filler – filling heads. Undo the 2 large round knurled piston
dismantle retaining bolts and remove the pistons from the barrels
piston by sliding them back towards you. Remove the O-rings
assembly and slide the piston pins out. Take apart the piston
assembly.

Step 6b Filler – Disassemble the cylinder barrels by loosening the 8

dismantle Allen bolts, turning the barrels, and pulling them back
air off of the bolts.
cylinder

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 Procedure Title: Sanitation Standard
Procedure No: SSOP37 Version No: 01
Operating Procedure – Machine 37
Approved By: Ally Sheedy Issue date: 25.01.15 Page No: 3 of 4

Undo the retaining bolts from the filling heads and

Step 6c Filler – remove the filling heads. Loosen the 6 Allen bolts and
dismantle slide the main body away from the piston. Remove the
filling half-moon clip and the seals from the piston. Remove
heads the 2 fill head retaining plates by undoing the 4 retaining
bolts from the front of the main filling block.
Do not steam sterilise plastic parts and air cylinder.

Step 7 Loosen the 2 Allen bolts on the half-moon retaining

Dismantle plate and slide out the rotary valve. Undo the 2 Allen
rotary bolts retaining the stainless steel guide. Undo the 4
valve retaining bolts underneath the rotary valve block and
remove the block. Remove pot rings from the rotary
table by removing the retaining O-rings.

Cleaning and sterilisation of machine parts

After dismantling, clean and sterilise machine parts as follows:
a. Clean all parts and seals with 1.5% Powerklenz detergent solution using the
appropriate colour coded brush and scouring pads.
b. Enclose seals into an autoclave bag and place into dilly with machine parts for
sterilisation. Wrap plastic and non-steamed machine parts in Alco wipes and store in
the red box on top of the utility cleaning sink (behind line 103) until reassembly.

Cleaning and sterilisation of machine and line

Cover electrical items using plastic bags (i.e., heaters, spot sealers and print head).
Using 1.5% Powerklenz detergent solution and working in a top-down cleaning motion,
clean the following equipment with the appropriate colour coded brush and scouring pads
to remove soil and debris.
• Conveyor belts
• Metal detector
• Machine
• Machine framework
Rinse off detergent with potable water. Do not use a hose pipe directly on the metal
detector or near electrical items such as heaters and spot sealers.
Sanitise the machine using 1.0% Steriklenz 5 solution. Steriklenz is a no rinse QAC
disinfectant and does not require a potable water rinse.

Cleaning verification
The Cleaning Supervisor is responsible for conducting random cleanliness checks each
week following completion of cleaning activities. This check should occur prior to the daily
pre-op inspection and weekly environmental monitoring conducted by QA personnel.

Issue 3 Dairy Made Case Study Page 15

 Procedure Title: Sanitation Standard
Procedure No: SSOP37 Version No: 01
Operating Procedure – Machine 37
Approved By: Ally Sheedy Issue date: 25.01.15 Page No: 4 of 4

Cleanliness check sites for random weekly inspections include the following areas.

CLEANLINESS CHECK SITE 1

Underside & frame of take-off conveyor

CLEANLINESS CHECK SITE 2

Metal detector reject box – empty & clean

CLEANLINESS CHECK SITE 3

Underside of rotary table

CLEANLINESS CHECK SITE 4

Plastic suckers on lid dispenser

Recordkeeping
Cleaning personnel are responsible for recording pre-clean, dismantling, and cleaning
activities in the Daily Cleaning Log (Ref F010).
Cleaning Supervisors are responsible for verifying completion of Daily Cleaning Logs and
signing-off following each shift.
Change Log

Version Date Changes

01 25.01.15 First issue; no amendments.

Issue 3 Dairy Made Case Study Page 16