PQS E01 CR-FR01-VP1.2.

doc 1 of 9 28 Jan 2009

WHO/PQS/E01/CR-FR01-VP1.2
PQS Type-examination protocol Original: English
Distribution: General

TITLE: Cold rooms and freezer rooms
Product verification protocol: E01/CR-FR01-VP1.2
Applies to specification ref(s): E01/CR-FR01.2
Date of origin: 02.08.2007
Date of last revision: 28.01.2009

Contents:
1. Scope: .....................................................................................................................1
2. Normative references: ...........................................................................................2
3. Terms and definitions:...........................................................................................2
4. Applicability: .........................................................................................................3
5. Sample-examination checklist:..............................................................................3
5.1 Evidence of conformity assessment:.................................................................3
5.2 Samples and supporting material:.....................................................................3
5.3 Type-examination procedure:...........................................................................4
5.4 Criteria for qualification:..................................................................................4
6. Quality control checklist: ......................................................................................5
6.1 Quality control standards: ................................................................................5
6.2 Quality control checklist: .................................................................................5
7. Pre-qualification evaluation: .................................................................................5
8. Modified products: ................................................................................................5
Annex 1 Compliance checklist ...................................................................................6


1. Scope:
E01/CR-FR01-VP1.2 is a type-examination protocol which will be used for
the pre-qualification evaluation of cold rooms and freezer room
manufacturers.

It should be read in conjunction with E01/CR-FR01.2 which describes the
performance requirements for a generic cold room or freezer room installation,
with packaged cooling units, suitable for storing vaccine. The document also
specifies the installation and maintenance advisory services that all
manufacturers must offer in order to become pre-qualified. It applies to rooms
up to a gross internal cubic capacity of 40m
3
.

A second verification protocol, E01/CR-FR01-VP2.2 completes the package.
This document is initially used by an employer or his QA assessor to describe
the requirements for a specific installation. The document also sets out the
installation, commissioning and handover procedure. The completed protocol
should also be read in conjunction with E01/CR-FR01.2, to which it refers.

E01/CR-FR01.1 and a completed E01/CR-FR01-VP2.2, together with an
employers other documents, are intended to form the basis for a contractual
agreement between the employer and the legal manufacturer or reseller for
the supply of the components required for a specific installation. These
PQS E01 CR-FR01-VP1.2.doc 2 of 9 28 Jan 2009
documents also forms the basis for a separate contractual agreement
between the employer and the installer.

2. Normative references:
EMAS: European Union Eco-Management and Audit Scheme.
IEC 60335-1: 2006 - Safety of household and similar electrical appliances,
Part 1: General requirements.
IEC 60364-1: 2005 Low-voltage electrical installations - Part 1: Fundamental
principles, assessment of general characteristics, definitions.
ISO 9001: 2008: Quality Management Systems Requirements.
ISO 14001: 2004: Environmental management systems - Requirements with
guidance for use.
ISO 20282-1: 2006: Ease of operation of everyday products - Part 1: Context
of use and user characteristics.
WHO/PQS/E06/TH02.1: Fixed gas or vapour pressure dial thermometer.
WHO/PQS/E06/TR03.1: Programmable electronic temperature and event
logger systems with integral alarm and auto-dialer options.
WHO/PQS/E06/TR03-VP2.1: Programmable electronic temperature and
event logger systems with integral alarm and auto-dialer options Quality
Assurance protocol.
WHO/PQS/E06/TR04.1: Wall-mounted pen recording thermometer.
WHO/PQS/E06/TR05.1: User-programmable temperature data loggers.
WHO/PQS/E01/CR-FR01.2: Cold rooms and freezer rooms.
WHO/PQS/E01/CR-FR01-VP2.2: Cold rooms and freezer rooms Quality
Assurance protocol.

3. Terms and definitions:
Annual review: The 12-monthly review which all PQS pre-qualified
manufacturers are required to pass in order to remain on the register of pre-
qualified companies.
Cold climate freeze prevention: Any mechanism which prevents the
temperature inside a cold room from dropping below +2C, under low ambient
temperature conditions, down to the temperature specified by the employer, at
the time of procurement, subject to a minimum of -10C.
Employer: The organization that contracts with the legal manufacturer or
reseller who will supply the system components and the installation and
maintenance advisory services described in specification E01/CR-FR01.2.
The Employer will typically contract with an installer who will install and
commission the installation under the supervision of a QA assessor and also
with a maintenance contractor who will maintain the installation.
Evaluator: An individual or organization (including a testing laboratory)
responsible for evaluating the suitability of the components and services
described in this specification for inclusion in the register of PQS pre-qualified
products.
Holdover time: The time in hours during which:
Cold room: All points remain between +2C and +10C after the power
supply has been disconnected when the room is exposed to the maximum
ambient temperature for which it is designed. In the case of a cold room
with cold climate freeze prevention, holdover time is also measured at an
ambient temperature of -10C.
PQS E01 CR-FR01-VP1.2.doc 3 of 9 28 Jan 2009
Freezer room: All points remain below -10C after the power supply has
been disconnected when the room is exposed to the maximum ambient
temperature for which it is designed.
Hot zone: Hot zone units must operate at a steady +43C ambient temperature
and over a+43C/+25C day/night cycling temperature range.
In writing: means communication by letter, fax or email.
Installation: The complete cold room or freezer room installation specified in
this document.
Installer: A person or organization has been appointed by the employer to
carry out the installation.
Legal Manufacturer: The natural or legal person with responsibility for the
design, manufacture, packaging and labelling of a product or device before it
is placed on the market under his own name, regardless of whether these
operations are carried out by that person himself or on his behalf by a third
party.
Maintenance Contractor: A person or organization contracted by the employer
to maintain the installation.
Moderate zone: Moderate zone units must operate at a steady +27C ambient
temperature and over a+27C/+10C day/night cycling temperature range.
Montreal Protocol: Montreal Protocol on Substances that Deplete the Ozone
Layer.
QA Assessor: the person or organization appointed by the employer to assess
the suitability of candidate approved installers, to evaluate their proposals and
to monitor the installation and commissioning of the installation on site.
QA: Quality Assurance.
Region: A contiguous geographical area within which the legal manufacturer
or reseller is able to provide the full range of services described in
specification E01/ CR-FR01.2.
Reseller: A commercial entity, licensed to act on behalf of a legal
manufacturer, and which carries product liability and warranty responsibilities
no less onerous than those carried by the legal manufacturer.
Temperate zone: Temperate zone units must operate at a steady +32C
ambient temperature and over a +32C/+15C day/night cycling temperature
range.
User: The person responsible for the day to day operation and temperature
monitoring of the room.

4. Applicability:
Type-examination will be carried out by an independent evaluator, appointed
by WHO. The extent of the geographical limits of any grant of pre-
qualification status will be reviewed and decided upon by WHO.

5. Sample-examination checklist:
5.1 Evidence of conformity assessment:
Key components must carry the CE mark and/or equivalent internationally
accepted evidence of conformity assessment.

5.2 Samples and supporting material:
The Legal Manufacturer or Reseller must supply the evaluator with a full
duplicate set of the Product Dossier already supplied to WHO in accordance
PQS E01 CR-FR01-VP1.2.doc 4 of 9 28 Jan 2009
with the requirements of specification clause 7. In addition, demonstration
samples are to be supplied, as follows:
Paired wall panel samples showing insulation, finishes, joint construction,
and panel locking arrangement;
Paired roof panel samples showing insulation, finishes, joint construction
and panel locking arrangement (if different from wall panels);
Paired floor panel samples showing insulation, finishes, joint construction
and panel locking arrangement;
Shelf sample, including support system.
If alternative panel finishes are available, provide small samples.
JPEG image of a typical installation for possible inclusion in the PQS data
sheet.

5.3 Type-examination procedure:
Step 1: Check all demonstration samples for similarities between different
models
1
, dissimilarities between samples of one model, and any defects or
damage.
Step 2: Record any differences between the samples ordered and those
received.
Step 3: Complete the compliance checklist in Annex 1. Record general
comments and recommendations for each section.
Step 4: Take a three quarter view digital photograph of each of the
demonstration samples.
Step 5: Obtain any additional supporting information required in writing
from the Legal Manufacturer or Reseller and attach this information to the
report.
Acceptance criteria: Inspection indicates full conformity with all major
specification requirements, subject to acceptable restrictions on temperature
zones
2
and region(s).

5.4 Criteria for qualification:
A final report must be issued after the type-examination is complete. The
report must contain the following data and analyses:
Summary: Conclusions and recommendations.
Compliance checklist: Completed Annex 1 checklist.
Photographs: Photographs of samples.
Temperature zone(s): Assessment of the temperature zone(s) for which the
product is suitable.
Region(s) Assessment of the region(s) within which the product should be
pre-qualified.
Annexes: Additional supporting documentation requested and received from
the Legal Manufacturer or Reseller during the course of the type-examination.


1
The purpose of this inspection is to establish whether products offered by competing companies are
re-badged versions of an otherwise identical product.
2
For example, it will be acceptable if a company proposes supplying temperate zone equipment to
temperate and moderate zone countries. If a hot zone area or country is included in the specified
region, this hot zone area or country must be excluded from the pre-qualification listing.
PQS E01 CR-FR01-VP1.2.doc 5 of 9 28 Jan 2009
6. Quality control checklist:
6.1 Quality control standards:
All reporting must be carried out in accordance with the requirements of this
document.

6.2 Quality control checklist:
An on-site inspection of the manufacturing plant is not required.

7. Pre-qualification evaluation:
An applicant company will qualify for inclusion on the register of PQS pre-
qualified cold rooms and freezer room suppliers, in accordance with WHO
procedures, provided the final report indicates that cold room and freezer
rooms components supplied by the company are likely to be able to achieve
full conformity with the requirements of specification E01 CR-FR01.2 and
verification protocol E01 CR-FR01-VP2.2 in the region(s) for which pre-
qualification is sought.

8. Modified products:
The legal manufacturer or reseller must notify WHO in writing of any changes
which affect the performance of the product. WHO will carry out a desk
evaluation of the reported change(s). If any change is deemed adversely to
affect the performance of the product, WHO may request full or partial re-
verification based on the type-examination procedures described in this
document.
PQS E01 CR-FR01-VP1.2.doc 6 of 9 28 Jan 2009
Annex 1 Compliance checklist
3

Spec
clause
Item
A. General information:
7. Dossier fee received: Yes No Part payment
7.
Type-examination fee
received:
Yes No Part payment
7.
Legal Manufacturer
details:
Name:
Address 1:
Address 2:
Address 3:
Address 4:
Tel:
Fax:
Email:
Web:










7.
Reseller details:
Name:
Address 1:
Address 2:
Address 3:
Address 4:
Tel:
Fax:
Email:
Web:
Applicable Not applicable









7.
Status:
Legal Manufacturer
Reseller



7. No. of regions:
7.
Description of regions
offered:

7.
Supporting evidence
offered for inclusion of
each region:


7. Evidence satisfactory: Yes No
7. No. of references: (minimum 5 from at least 3 separate countries)
7.
References
satisfactory:
Yes No
General information comments:
B. Technical details:
7. Cold room sizes:
7. Freezer room sizes:
4.2.2 Temperature zones
Hot zone compliant? Yes No
Temperate zone compliant? Yes No
Moderate zone compliant? Yes No
Cold climate freeze prevention compliant? Yes No
4.2.3 Temperature control Cold room temperature control acceptable? Yes No

3
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PQS E01 CR-FR01-VP1.2.doc 7 of 9 28 Jan 2009
Spec
clause
Item

Freezer room temperature control acceptable? Yes No

4.2.4 Holdover time
Cold room holdover time achievable? Yes No
Freezer room holdover time achievable? Yes No
Temperature control comments:
4.2.5 Electrical safety rating Compliance with IEC 60335-1 certified? Yes No
4.2.6
Voltage, frequency and
phasing
List options offered:
Options compatible with requested countries? Yes No

4.2.7
Voltage stabilization
and surge protection
Voltage stabilization offered? Yes No
Surge protection offered? Yes No
Electrical requirements comments:
4.2.8 Panel insulation
Panel insulation options offered:
Hot zone compliant? Yes No
Temperate zone compliant? Yes No
Moderate zone compliant? Yes No
4.2.9 Panel construction
Panel construction(s) offered:
Panel construction satisfactory? Yes No
Joint construction satisfactory? Yes No
Wall/roof panel finish satisfactory? Yes No
Floor panel finish(es) satisfactory? Yes No
4.2.10 Shared walls
Shared wall construction(s) offered:
Shared wall construction satisfactory? Yes No
4.2.11 Door construction
Door construction(s) offered:
Door construction satisfactory? Yes No
Door size options satisfactory? Yes No
Strip curtain offered? Yes No
Panel and door construction comments:
4.2.12
Door frame heating
element
Door frame heating element offered? Yes No

4.2.13 Pressure release valve
Pressure release valve offered? Yes No

4.2.14 Heater mat Heater mat offered? Yes No
4.2.15 Shelving
Shelving option(s) offered:
Shelving construction satisfactory? Yes No
Shelving size options satisfactory? Yes No
Ancillary fittings comments:
4.2.16 Refrigeration units
Refrigeration unit option(s) offered:
Refrigerant(s) satisfactory? Yes No
Defrosting system satisfactory? Yes No
Duty sharing system satisfactory? Yes No
High/low voltage protection satisfactory? Yes No
Cut-out system satisfactory? Yes No
4.2.17
Evaporator plume
guard
Evaporator plume guard offered:
Plume guard system satisfactory? Yes No
4.2.18
Cold climate
protection
Freeze-protection system offered:
Freeze-protection system satisfactory? Yes No
Refrigeration unit comments:
4.2.19 Lighting
Lighting system offered:
Lighting system satisfactory? Yes No
4.2.20 Alarm system Alarm system(s) offered:
PQS E01 CR-FR01-VP1.2.doc 8 of 9 28 Jan 2009
Spec
clause
Item
Alarm systems PQS-compliant? Yes No
4.2.21 Temperature recording
Temperature recording system(s) offered:
Temp recording systems PQS-compliant? Yes No
Temperature monitoring, alarm and lighting comments:
4.4.2 Overall dimensions Component sizes comply? Yes No
4.4.3 Weight Component weights comply? Yes No
Dimension and weight comments:
4.7.1 Refrigerant
Refrigerants comply with Montreal Protocol? Yes No

4.7.2 Foaming agents Gas complies with Montreal Protocol? Yes No
4.7.3
Other restricted
materials
Restricted materials in system components? Yes No

Refrigerant and materials comments:
C. Norms and standards:
7. Type approval details:
Details:
Satisfactory? Yes No
7.
Current ISO 9001:
2000 certification:
Satisfactory? Yes No
7.
Environmental audit
scheme
Type:
Current? Yes No (Note: not mandatory)
7. Laboratory test reports Details:
Norms and standards comments:
D. Instructions, training, other documents
4.11.1
Sample installation
instructions
Supplied? Yes No
If yes is it satisfactory? Yes No
4.11.1
Sample service
instructions
Supplied? Yes No
If yes is it satisfactory? Yes No
4.11.1
Sample user
instructions
Supplied? Yes No
If yes is it satisfactory? Yes No
4.12 Training
Offered? Yes No
If yes is proposal satisfactory? Yes No
4.8 Warranty agreement
Supplied? Yes No
If yes is it compliant? Yes No
8.
On-site maintenance
agreement
Supplied? Yes No
If yes is it satisfactory? Yes No
Documentation comments:
E. Conclusions:
Overall summary:
DECISION: Pre-qualify? Reject
PQS E01 CR-FR01-VP1.2.doc 9 of 9 28 Jan 2009

Revision history:
Date Change summary Reason for change Approved
20.03.2006 Original
09.05.2007

Revised to SMc comments &
teleconference UK, SMc, AG
26.04.07

16.05.2007 Final review version
02.08.2007 Final version no changes.
28.01.2009 Major general revision
eliminating manufacturer-
approved installers and
maintenance contractors.
1: amended.
2: Normative references updated.
3: definitions changed.
7: amended
Annex 1: amended
Response to manufacturer comments.