Workflow

FOR VALIDATION
OF PERFORMANCE

Version 2009-02-16
Handled by: Plant Solutions
Checked by: Pontus Luedtke
Approved by: Ferdinand Franz

VALIDATION

OF

PERFORMANCE
 Guideline for Validation of Performance
Tetra Pak Processing Systems Page 2 of 10
Plant Solutions 2009-02-16

Table of Contents / Executive Summary on the Output

Table of Contents / Executive Summary on the Output .................................................. 2
Introduction ..................................................................................................................... 3

Validation of Performance (step 1 - 4) ............................................................................ 5

1. Verify Performance Preconditions......................................................................... 5
The output from this step is as built design and functionality
2. Set up for Performance Validation ........................................................................ 6
The output from this step is equipment ready for performance test
3. Performance Test ................................................................................................. 8
The output from this step is completed performance test
4. Performance Records ........................................................................................... 8
The output is performance test records to be signed in the performance test certificate.

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
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Introduction
This document describes s, in terms of a workflow, how to validate the performance derived from customer
needs. Separating the selected Performance from the Basic Intended Purpose (commissioning criteria) from
selected performance (performance criteria), provides “Performance Guarantee” possibilities, i.e. contractual
performance criteria.. It is a part of the Deliver phase of the UCCD business approach (figure 1 and 2) and it
addresses the Order Fulfilment Capital Equipment.

Background
Various performance demands on
production need different functionality
and technical solutions to achieve
Figure 1. The UCCD business approach according to Tetra Pak Processing Systems customer needs. This has generated a
working methodology to secure
Deliver Installation to
Performance
performance, with a base platform with
1
Verify Perf.
options for satisfying unique needs.
Preconditions

Commissioning
Using this methodology and the
and Performance 2 4 approved Design Elements will give
Criteria. Trimming of Perfor-

Detailed Solution
Perf. Parameters mance
records repeated and verified performance,
3 which we can support and validate in a
Performance
Test project
The aim of this document is to present
a workflow to validate the
Figure 2. Activities to validate performance in the Deliver phase of the UCCD
business approach. performance (equipment + auto-
mation) of a Production Solution. This
to secure the performance based on
the customer needs and the
corresponding functionality.
The “building block” to secure the
wanted performance is the Process
Path. Each process cell can contain
several Process Paths. A Process Path
can contain several functions.
The Process Path is described as a
functional platform with basic
functionality. On the platform optional
functionality can be added to better
fulfil the customer needs (figure 3). All
selectable solutions are supported by
Tetra PlantMaster.

Figure 3. Examples of different Process Paths shown in a functional diagram. Each process cell
can contain several Process Paths and a Process Path can contain several functions.

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
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Plant Solutions 2009-02-16

Performance Requirements
Supply Capability
- Delivery defects & accuracy
Performance Requirements - Supply flexibility
- Future expansion/
Food Safety adaptation

- Microbiological safety Performance Requirements

- Chemical contamination Food Quality
- Traceability

Performance Requirements - Consistency of product

quality
Environment, - Critical QA parameters
Health & Safety in production

- Emissions Performance Requirements

- Harmful substances
- Occupational health Operational
- Product safety
Efficiency & Costs
- OEE/ Time Utilisation
- Product losses/ Yield
- Media consumption
- Personnel
- Operating and
Figure 4. The five main performance Investment costs
requirement areas and Performance
requirements according to Tetra Pak
Processing System.

The structure is:

• Performance requirement area Presently Plant Solution is working with the following
– Performance requirement performance requirements (highlighted in figure);
Performance parameter Consistency of product quality, Media consumption (water
Performance criteria consumption), and Product losses.

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
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Plant Solutions 2009-02-16

Validation of Performance (step 1 - 4) In this area an explanatory example will try to

visualize the different steps in the Workflow.

Deliver Installation to The validation of performance

Performance
1 start off with equipment
Verify Perf.
Preconditions commissioned (TG3), i.e. a
Commissioning signed commissioning test
2 4
and Performance
Criteria. Trimming of Perfor- certificate.
Perf. Parameters mance
records
Detailed Solution The input to the validation of
3 performance is basically the
Performance
Test
performance criteria (exhibit
no 6 in the Model Contract).
Figure 5 Activities concerning the validation of Tetra Pak Model Contract
performance in the main activity “Installation to Exhibit 6, Commissioning
Performance” in the Deliver phase. and Performance Criteria,
describes the tests done by
Tetra Pak to fulfil the contractual obligations for the supply of
Equipment. Exhibit 6 includes only the technical parameters to be
measured and the conditions
FACTS 1 for the tests, while the legal
aspects are described in
Commissioning Test
Demonstrates that the plant serves its basic intended Exhibit 10, Plant Completion
purpose, which means the ability to produce the products Procedures.
(not amounts) defined by the SKU-list and running according
to the technological diagrams as well as fulfilling the legal The tests are of two types,
demands. Commissioning Tests and
The Commissioning Test secures that the tested Performance Tests. The
equipment/unit/line will supply a safe product and attains reason for this split is to
the agreed Commissioning Criteria; i.e. is ready for enable the customer to start
commercial production.
production as soon as
Performance Test possible after the
Performance Tests are run under commercial operation of the commissioning test, as well as
plant and when fulfilled demonstrating that the plant attains the to make it possible do the
agreed Performance Criteria (selected performance). final fine-tuning during actual
Selected performance means performance to fulfil customer production conditions
needs not covered by the Basic Intended Purpose, for
example consistent product quality or product losses. enabling the performance
tests.

1. Verify Performance Preconditions

Coordinate activities with other performance partners. Verify the
interfaces between the suppliers of equipment for validation (as in
contract). For instance internal suppliers as Business unit D&B,
Packaging as well as external suppliers of existing and new equipment
and packaging machines.

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Guideline for Validation of Performance
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Plant Solutions 2009-02-16

Verify Plant Design and FACTS 2

Functionality, i.e. check if the
plant is built according to Performance Parameter – structure with example
performance criteria. Check Test area Raw milk reception line Wxx to
fulfilment of Design Criteria (e.g. receiving silo Cxx
utility and raw material availability). Parameter Process water consumption
during a flush between raw milk
Follow up Design change road tankers, or during a flush
notes as internal redesign or before CIP.
Variation orders, (e.g. notes from
Value xxx litres
H&S review, local condition
reviews). Check if performance Tolerance +/- yyy % (or litres)
has been affected by the change Operating The circuit is flushed using fresh
in design. conditions water. The pipe should initially
be full of milk. The level in the
Deviations in above could be balance should be the same
handled by a recalculation of the before and after the test.
affected performance parameters. Test point(s) Pipe after fresh water valve
The output from this step is as Test method Water loss is measured as
built design and functionality. amount of water from the fresh
water valve, using a flow meter
at the test point.

2. Set up for Performance Validation

Verify correct information in reports from the control system, i.e.

enabling measurement validation and acceptance.
Verify measurement methods, as described in the performance
criteria. All necessary measuring equipment needs to be available.
Verify sampling and testing methods with laboratory.
Set Process Parameters in the control system. The handling of mix
phases are controlled by different sets of process parameters, deciding
how the mix phases are distributed. Two kinds of parameters are
defined; function oriented parameters, deciding where the mix phases
are going, and physical parameters, defining volumes and times for the
actual physical design.
Perform Pre-testing and Adjust Performance Parameters.
The output from this step is equipment ready for performance test

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
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Plant Solutions 2009-02-16

FACTS 4

Figure 6. Physical Parameters in Tank – Line – Tank (compact valve cluster)

Physical Parameters
1 FillToDrainAmount (emptying, source tank)
2 FlushToDrainAmount (emptying, source tank)
3 FillToDestAmount (production)
5 FlushToDestAmount (production)
7 FillToTankAmount (filling, dest tank)
8 FlushToTankAmount(filling, dest tank)

Figure 7. Function Oriented Parameters:

Function Oriented Parameters

4 FillToReclaimAmount
6 FlushToReclaimAmount
9 MixZoneAmount
11 FillMixZoneToDestAmount
12 FlushMixZoneToDestAmount

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
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Plant Solutions 2009-02-16

3. Performance Test
Verify and agree on test procedure/-s
Measure in accordance with
FACTS 4
the performance criteria.
Adjust parameters/Modify Test principle
solution
Production Cycle, (minimum scenario)
If the performance parameter From empty pipe to empty pipe
values and tolerances are met, · Filling of pipe
then the test is considered · Production (with a defined time)
completed. If not, adjustments · Empting of pipe
· Cleaning
and modifications are to be
carried out and new tests
performed. Empty
Production (time)
CIP Empty

N.B. If customer gives no

access for adjustments and Figure 8: A Production Cycle from empty pipe to empty
modification, this will result in pipe.
a signed performance test The Production Cycle is run over each Process Path,
certificate. For details see giving evaluation and validation possibilities.
Exhibit 10 in the Contract.
The output from this step is completed performance test

4. Performance Records
The output is performance test records to be signed in the
performance test certificate.
.
.

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
 Workflow for Validation of Performance
Tetra Pak Processing Systems Page 9 of 10
Plant Solutions 2009-02-16

Tetra Pak Processing Systems

Ruben Rausings gata, 221 86 Lund, Sweden, Visiting address: Bryggaregatan 23
Telephone +46 46 36 10 00
Copyright © 2008 Tetra Pak Processing Systems, Lund
  2008 Tetra Pak Processing Systems, Lund, Sweden. Produced by Plant Solutions.

www.tetrapak.com We reserve the right to introduce design modifications

without prior notice. Tetra Pak, and protects what's good
are trademarks belonging to the Tetra Pak Group.