VADILAL INDUSTRIES LIMITED

Issue No.
Issue Date PRP VERIFICATION CHECK LIST: APPENDIX 2

Loaction : Ice cream , Paneer , Shrikhand

5 - Excellent , 4 - Good , 3 - Satisfactory , 2 - Fair , 1 - Unsatisfactory

Sr. no. Requirement Sr. NO

External 2
1
Standards

2 Security
2 Security

8
 8

9
Layout, Product
3 Flow and
segregation

10

11

12
 13

14

15

16

17

18

19

20

4 Building fabric
21
4 Building fabric

22

23

24

25

26

27

28

Utiliti4s – water,
5 ice, air and other 29
gases
 Utiliti4s – water,
5 ice, air and other
gases

30

31

32

6 Equpment

33

34

35

36

7 Maintenance

37

38
39

40

41

42

43
 44

8 Staff facilities

45
45

46

47

48
 49

50
Chemical and
9 physical product
contamination

51

52

10 Metal Control

53
 54

55

Glass, brittle
plastic, ceramics
11
and similar
materials

56

57
 Products Packed
into glass or 58
12
other brittle
containers

59

13 Wood 60
 61

Foreign body
detection and
14
removal
equipment
62

63

64

65

15 Filters and sieves

15 Filters and sieves

66

66

67

68

69

Metal detectors
16 and X-ray
equipment
 69

Metal detectors
16 and X-ray
equipment

70

71
17 Magnets 72

Optical sorting
18 73
equipment

74

Container
cleanliness –
19 glass jars, cans
and other rigid
containers

75

76
 77

Housekeeping
20
and hygiene

78

79

80
 81

82

Cleaning in place
21
(CIP)

83

84
 85

Waste/ waste
22
disposal 86

87

88

89
 90

23 Pest Control
91

92

93

94
 95

96

97

98

24 Storage Facilities

99
 100

101

102

103

104

Dispatch and
25
transport
 Dispatch and
25
transport

105

106

107

108

109

110
 111

Product Control
26 ( Product design /
development)

112

113

114

115

116
 117

118

Product Control
27 ( Management of
Allergens )

119

120
 121

122

123

124

125

Product Control
( Provenance,
assured status and 126
28
claims of identity
preserved
material)

127
 128

Product Control
29 (Product Packaging
)
129

130

131

Product Packaging 132

( Product
30
inspection and
testing )

133
 134

135

Product Control
31 ( Laboratory
testing )

136

137

Product Control
32 138
( Product release )
 139

140

141

Process Control
33 ( Control of
Operations )
142

143
 144

145

146
Process Control
( Quantity –
34 Weight, Volume,
and Number
Control )
147

148

Process Contrl
( Calibration and
Control of
35 149
Measuring and
Monitoring
Devices )
 Monitoring
Devices )

150

151

152

153

Personnel - 154
TRAINING (RAW
MATERIAL
HANDLING,
36
PREPARATION,
PROCESSING,
PACKING, AND
STORAGE AREAS)

155

156

157
 157

PERSONAL
HYGIENE (RAW
MATERIALS
HANDLING,
37 158
PREPARATION,
PROCESSING,
PACKING, AND
STORAGE AREAS)

159

160

161

162

MEDICAL
38 163
SCREENING

164
 165

166

PROTECTIVE 167
CLOTHING
(EMPLOYEES OR
39
VISITORS TO
PRODUCTION
AREAS)

168

169
 170

171

SUPPLIER AND
RAW MATERIAL
40 APPROVAL AND
PERFORMANCE
MONITORING

172

173
 RAW MATERIAL 174
AND PACKAGING
41 ACCEPTANCE AND
MONITORING
PROCEDURES

175

176
MANAGEMENT OF
42 SUPPLIERS OF
SERVICES

178

179

180

MANAGEMENT OF
43 OUTSOURCED
PROCESSING
 MANAGEMENT OF
43 OUTSOURCED
PROCESSING

181

182
 Document No
VADILAL INDUSTRIES LIMITED

Rev. No.:
PRP VERIFICATION CHECK LIST: APPENDIX 2 Rev. Date :

Date :
r , Shrikhand

sfactory , 2 - Fair , 1 - Unsatisfactory

Achieved
Requirement / question Score
score
Consideration given to local activities and the site environment,
which may have an adverse impact on finished product integrity,
and measures taken to prevent contamination. Where
measures have been put into place to protect the site (from
potential contaminants, flooding, etc.), they reviewed in 5 5
response to any changes.

The external areas maintained in good order. Where buildings

are surrounded by grassed or planted areas, they regularly
tended and well-maintained. External traffic routes under site
control suitably surfaced and maintained in good repair to
5 3
avoid contamination of the product.

The building fabric maintained to minimize potential for product

contamination (e.g., elimination of bird roosting sites, sealing
gaps around pipes to prevent pest entry, ingress of water, and
other contaminants).
5 3

The company undertake a documented assessment of the

security arrangements and potential risks to the products from
any deliberate attempt to inflict contamination or damage. Areas
assessed according to risk; sensitive or restricted areas
defined, clearly marked, monitored, and controlled. Identified
security arrangements implemented and reviewed at least 5 4
annually.
Measures in place to ensure only authorized personnel have
access to production and storage areas and access to the site
by employees, contractors, and visitors controlled. A visitor
reporting system in place. Staff trained in site security
procedures and encouraged to report unidentified or unknown
visitors. 5 3

Where required by legislation, the site registered with, or be

approved by, the appropriate authority.
5 5

There a plan of the site which designates areas where product

is at different levels of risk from contamination; that is:

- Enclosed product areas

- Low-risk areas

5 4
- High-care areas

- High-rish areas.

This taken into account when determining the prerequisite

programs for the particular areas of the site.

The site plan define:

- Access points for personnel and travel routes

- Location of staff facilities and routes to the facilities from

places of work
- Production process flow

- Routes for the removal of waste

5 3
- Routes for the movement of rework.
 5 3

If it is necessary to allow access through production areas,

designated walkways provided taht ensure there is adequate
segregation from materials. All facilities designed and
positioned, where possible, so that movement of personnel is by
simple, logical routes. The movement of waste and rework not
compromise the safety or products.

Contractors and visitors, including drivers, made aware of all

procedures for access to premises and the requirements of the
areas they are visiting, with special reference to hazards and
potential product contamination. Contractors involved in
maintenance or repair activities under the supervision of a 5 3
nominated person.

In low-risk areas the process flow together with the use of

demonstrably effective procedures in place to minimize the risk
of the contamination of raw materials,
intermediate/semiprocessed products, packaging, and finished 5 5
products.

Where high-care areas are part of the manufacturing site there

should be physical segregation between these areas and other
parts of the site. Segregation take into account the flow of
product, nature of materials, equipment, personnel, waste,
airflow, air quality, and utilities provision. Where physical
barriers are not in place, the site have undertaken a full
evaluation of the risks of cross-contamination and alternative 5 3
effective processes in place to protect products from
contamination.

Where high-risk areas are part of the manufacturing site, there

physical segregation between these areas and other parts of the
site. Segregation take into account the flow of product, nature
of materials, equipment, personnel, waste, airflow, air quality,
and utilities provision. The location of transfer points not
compromise the segregation between high-risk areas and other
areas of the factory. Practices in place to minimize risk of 5 3
product contamination (e.g., the disinfection of materials on
engry).
Premesis allow sufficient working space and storage capacity
to enable all operations to be carried out properly under safe
hygienic conditions. 5 3

Temporary structures constructed during building work or

refurbishment, etc. designed and located to avoid pest
harborage and ensure the safety and quality of products.
5 3

Walls constructed, finished, and maintained to prevent the

accumulation of dirt, minimize condensation and mold growth,
and facilitate cleaning. 5 3

Floors suitably hard-wearing to meet the demands of the

process, and withstand cleaning materials and methods. They
impervious and maintained in good repair. 5 3

Drainage, where provided, located, designed, and maintained

to minimize risk of product contamination and not compromise
product safety. Machinery and piping arranged so that,
wherever feasible, process waste water goes directly to drain.
Where significant amounts of water are used, or direct piping to
5 3
drain is not feasible, floors have adequate falls to cope with the
flow of any water or effluent toward suitable drainage.

Where sites include high-care or high-risk facilities, there a

plan of the drains for these areas which shows the direction of
flow and location of any equipment fitted to prevent the backup
of waste water. The flow of drains not present a risk of 5 3
contamination of the high-care/risk area.

Ceilings and overheads constructed, finished, and maintained

to prevent the risk of product contamination. 5 3

Where suspended ceilings or roof voids are present, adequate

access to the void provided to facilitate inspection for pest
activity, unless the void is fully sealed. 5 5

Where there is a risk to product, windows, and roof glazing

which is designed to be opened for ventilation purposes,
adequately screened to prevent the ingress of pests. 5 3
Where they pose a risk to product, glass windows protected
against breakage.
5 5

Doors maintained in good condition. External doors and dock

levelers close-fitting or adequately proofed. External doors to
open product areas not be opened during production periods
except in emergencies. Where external doors to enclosed 5 4
product areas are opened, suitable precautions taken to
prevent pest ingress.

Suitable and sufficient lighting provided for correct operation of

processes, inspection of product, and effective cleaning.
5 4

Where they constitute a risk to product, bulbs and strip lights -

including those on electric flykiller devices - adequately
protected. Where full protection cannot be provided, alternative
management such as wire mesh screens or monitoring 5 5
procedures in place.

Adequate ventilation and extraction provided in product

storage and processing environments to prevent condensation 5 4
or excessive dust.

High-risk areas supplied with sufficient changes of filtered air.

The filter specification used and frequency of air changes
documented. This based on a risk assessment, taking into
account the source of the air and the requirement to maintain a 5 5
positive air pressure relative to the surrounding areas.

All water used as a raw material in the manufacture of

processed food, the preparation of product, or for equipment or
plant cleaning supplied in sufficient quantity, be potable at
point of use, or pose no risk of contamination according to
applicable legislation. The microbiological and chemical quality
of water analyzed at least annually. The sampling points and
frequency of analysis based on risk, taking into account the 5 5
source of the water, on-site storage and distribution facilities,
prevous samples history, and usage.

An up-to-date plan available of the water distribution system on

site, including holding tanks, water treatment, and water
recycling as appropriate. The plan used as a basis for water
5 5
sampling and the management of water quality.
Where legislation specifically permits the use of water which
may not be potable for initial product cleaning (e.g., for the
storage/washing of fish), the water meet the designated legal 5 5
requirement for this operation.

Air, other gases, and steam used directly in contact with or as

an ingredient in products monitored to ensure this does not
represent a contamination risk. Compressed air used directly in
contact wih the product filtered. 5 5

All equipment constructed of appropriate materials. The design

and placement of equipment ensure it can be effectively
cleaned and maintained. 5 5

Equipment which is in direct contact with food suitable for food

contact and meet legal requirements where applicable.
5 5

There a documented planned maintenance shcedule or

condition monitoring system which includes all plant and
processing equipment. The maintenance requirements defined
5 5
when commissioning new equipment.

In addition to any planned maintenance program, where there is

a risk of product contamination by foreign bodies arising from
equipment damage, the equipment inspected at predetermined
intervals, inspection results documented, and appropriate action 5 4
taken.

Where temporary repairs are made, these controlled to ensure

the safety or legality of product is not jeopardized. These
temporary measures permanently repaired as soon as
practicable and within a defined timescale. 5 5

The company ensure that the safety or legality of product is not

jeopardized during maintenance and subsequent cleaning
operations. Maintenance work followed by a documented
hygiene clearance procedure, which records that product
contamination hazards have been removed from machinery and 5 3
equipment.

Materials used for equipment and plant maintenance and that

pose a risk by direct or indirect contact with raw materials,
intermediate, and finished products, such as lubricating oil, 5 5
food grade.
Engineering workshops kept clean and tidy and controls in
place to prevent contamination risks to the product (e.g.,
provision of swarf mats at the entrance/exit of workshops).
5 3

Designated changing facilities provided for all personnel,

whether staff, visitor, or contractor. These located to allow
direct access to the production, packing, or storage areas
without recourse to any external area. Where this is not
possible, a risk assessment carried out and procedures 5 4
implemented accordingly (e.g., the provision of cleaning facilities
for footwear).

Storage facilities of sufficient size to accommodate personal

items provided for all personnel who work in raw material
handling, preparation, processing, packing, and storage areas. 5 4

Outdoor clothing and other personal items stored separately

from workwear within the changing facilities. Facilities available
to separate clean and dirty workwear. 5 4

Where an operation includes a high-care area, personnel enter

via a specially designated changing facility with arrangements to
ensure that protective clothing will not be contaminated before
entry to the high-care area. The changing facilities incorporate
the following requirements:

- Clear instructions for the order of changing into dedicated

protective clothes to prevent the contamination of clean clothing

- Dedicated footwear (by exception shoe coverings provided

for visitors only) to be worn in the high-care area

- An effective system provided to segregate areas for wearing

5 3
high-care from other footwear (e.g., a barrier or bench system)
or there an effective boot wash on entrance to the high-care
area
- Protective clothing visually distinctive from that worn in lower-
risk areas and not be worn outside of the high-care area

- Handwashing during the changing procedure incorporated to

prevent contamination of the clean protective clothing

- On entry to high-care areas, handwashing and disinfection

provided.

Where an operation includes a high-risk area, personnel enter

via a specially designated changing facility at the entrance to the
high-risk area. The changing facilities include the following
requirements:

- Clear instructions for the order of changing into dedicated

protective clothes to prevent the contamination of clean clothing

- Dedicated footwear provided to be worn in the high-risk area

- An effective system provided to segregate areas for wearing

high-risk and other footwear, e.g., a barrier or bench system
5 3

- Protective clothing visually distinctive from that worn in other

areas and not be worn outside of the high-risk area

- Handwashing during the changing procedure incorporated to

prevent contamination of the clean protective clothing

- On entry to high-risk reas, handwashing and disinfection

provided.

Suitable and sufficient handwashing facilities provided at

access to, and at other appropriate points within, production
areas. Such handwash facilities provide as a minimum:

5 3
- Sufficient quantity of water at a suitable temperature

- Liquid soap 5 3

- Single use towels or suitably designed and located air driers

- Water taps with handfree operation

- Advisory signs to prompt handwashing.

Washrooms adequately segregated and not open directly into

production, packing, and storage areas. Washrooms provided
with handwashing facilities comprising:

- Basins with soap and water at a suitable temperature

- Adequate hand-drying facilities

5 3
- Advisory signs to prompt handwashing.

Where handwashing facilities within washroom facilities are the

only facilities provided before re-entering production, the
requirements of 4.8.6 apply and signs in place to direct
people to handwash facilities before entering production.

Where smoking is allowed under national law, designated

controlled smoking areas provided which are both isolated
from production areas to an extent that ensures smoke cannot
reach the product and fitted with sufficient extraction to the
exterior of the building. Adequate arrangements for dealing with
smokers' waste provided at smoking facilities, both inside and 5 5
at exterior locations.

All food pb rought into manufacturing premises by staff

appropriately stored in a clean and hygienic state. No food
taken into storage, processing, or production areas. Where
eating of food is allowed outside during breaks, this in suitable
designated areas with appropriate control of waste. 5 3
Where cafeteria facilities are provided on the premises, they
suitably controlled to prevent contamination of product (e.g., as
a source of food poisoning or introduction of allergenic material
to the site). 5 3

Processes in place to manage the use, storage, and handling

of nonfood chemicals to prevent chemical contamination. These
include as a minimum:

- An approved list of chemicals for purchase

- Availability of material safety data sheets and specifications

- Confirmation of suitability for use in a food processing

environment 5 3
- Avoidance of strongly scented products

- The labeling and/or identification of containers of chemicals at

all times
- Segregated and secure storage with restricted access to
authorized personnel
- Use by trained personnel only.

Where strongly scented or taint-forming materials have to be

used, for instance for building work
5 5

There a documented policy for the control of the use of sharp

metal implements including knives, cutting blades on equipment,
needles, and wires. This include a record of inspection for
damage and the investigation of any lost items. Snapoff blade 5 3
knives not be used.

The purchase of ingredients and packaging which use staples or

other foreign-body hazards as part of the packaging materials
avoided. Staples and paperclips not be used in open product
areas. Where staples or other items are present as packaging
materials or closures, appropriate precautions taken to 5 3
minimize the risk of product contamination.
Glass or other briggle materials excluded or protected against
breakage in areas where open products are handled or there is
a risk of product contamination. 5 5

Documented procedures for handling glass and other brittle

materials in place and implemented to ensure that necessary
precautions are taken. Procedures include as a minimum:

- A list of items detailing location, number, type, and condition

5 5
- Recorded checks of condition of items, carried out at a
specified frequency that is based on the level of risk to the
product

- Details on cleaning or replacing items to minimize potential for

product contamination.

Documented procedures detailing the action to be taken in case

of breakage of glass or other brittle items implemented and
include the following:

- Quarantining the products and production area that were

potentially affected
- Cleaning the production area

- Inspecting the production area and authorizing to continue 5 4

production
- Changing of workwear and inspection of footwear

- Specifying those staff authorized to carry out the above points

- Recording the breakage incident.

The storage of the containers segregated from the storage of

raw materials, product, or other packaging.
5 5

Systems in place to manage container breakages between the

container cleaning/inspection point and container closure. This
include, as a minimum, documented instructions which ensure:
- The removal and disposal of at-risk products in the vicinity of
the breakage; this may be specific for different equipment or
areas of the production line

- The effective cleaning of the line or equipment which may be

contaminated by fragments of the container. Cleaning not
result in the further dispersal of fragments, for instance by the
use of high pressure water or air

- The use of dedicated, clearly identifiable cleaning equipment

(e.g., color coded) for removal of container breakages. Such
equipment stored separately from other cleaning equipment
5 3

- The use of dedicated, accessible, lidded waste containers for

the collection of damaged containers and fragments

- A documented inspection of production equipment is

undertaken following the cleaning of a breakage to ensure
cleaning has effectively removed any risk of further
contamination

- Authorization is given for production to restart following

cleaning

- The area around the line is kept clear of broken glass.

Records maintained of all container breakages on the line.

Where no breakages have occurred during a production period,
this also be recorded. This record reviewed to identify trends
5 3
and potential line or container improvements.

Wood should not be used in open product areas except where

this is a process requirement (e.g., maturation of products in
wood). Where the use of wood cannot be avoided, the condition
of wood continually monitored to ensure it is in good condition
and free from damage or splinters which could contaminate 5 4
products.

A documented assessment in association with the HACCP

study carried out on each production process to identify the
potential use of equipment to detect or remove foreign body
contamination. Typical equipment to be considered may include:
- Filters

- Sieves

- Metal detection 5 3

- Magnets

- Optical sorting equipment

- X-ray detection equipment

- Other physical separation equipment e.g., gravity separation,

fluid bed technology.
The type, location, and sensitivity of the detection and/or
removal method specified as part of the company's
documented system. Industry best practice applied with regard
to the nature of the ingredient, material, product, and/or the
packed product. The location of the equipment or any other 5 5
factors influencing the sensitivity of the equipment validated
and justified.

The company ensure that the frequency of the testing of the

foreign body detection and/or removal equipment is defined and
takes into consideration:

- Specific customer requirements 5 5

- The company's ability to identify, hold, and prevent the release

of any affected materials, should the equipment fail.

Where foreign material is detected or removed by the

equipment, the source of any unexpected material
investigated. Information on rejected materials used to identify
trends and where possible instigate preventive action to reduce 5 5
the occurrence of contamination by the foreign material.

Filters and sieves used for foreign body control of a specified

mesh size or gauge and designed to provide the maximum
practical protection for the product. Materials retained or
removed by the system examined and recorded to identify
contamination risks. 5 3
Filters and sieves regularly inspected or tested for damage on
a documented frequency based on risk. Records maintained of
the checks. Where defective filters or sieves are identified this
recorded and the potential for contamination of products 5 3
investigated and appropriate action taken.

Metal detection equipment in place unless risk assessment

demonstrates that this does not improve the protection of final
products from metal contamination. Where metal detectors are
not used justification documented. The absence of metal
detection would only normally be based on the use of an
alternative, more effective, method of protection (e.g., use of X- 5 5
ray, fine sieves, or filtration of products).

Where metal detectors or X-ray equipment is used, this

situated at the latest practical step in the process flow and,
wherever possible, after the product has been packaged.
5 5

The metal detector or X-ray equipment incorporate one of the

following:

- An automatic rejection device, for continuous inline systems,

which divert contaminated product either out of the product
flow or to a secure unit accessible only to authorized personnel

- A belt stop system with an alarm where the product cannot be 5 5

automatically rejected, e.g., for very large packs

- Inline detectors which identify the location of the contaminant

operated to allow effective segregation of the affected product.

The company establish and implement documented

procedures for the operation and testing of the metal or X-ray
equipment. This include as a minimum:

- Responsibilities for the testing of equipment

5 5
- The operating effectiveness and sensitivity of the equipment
5 5
and any variation to this for particular products

- The methods and frequency of checking the detector

- Recording of the results of checks.

Metal detector checking procedures based on best practice

and as a minimum include:

- Use of test pieces incorporating a sphere of metal of a knwn

diameter. The test pieces marked with the size and type of test
material contained

- Tests carried out using separate test pieces containing ferrous

metal, stainless steel, and typically nonferrous metal, unless the
product is within a foil container

- A test that both the detection and rejection mechanisms are

working effectively under normal working conditions

- Checks that test the memory/reset function of the metal 5 5

detector by passing successive test packs through the unit.

In addition, where metal detectors are incorporated on

conveyors:

- The test piece passed as close as possible to the center of

the metal detector aperature and wherever possible the test will
be carried out by inserting the test piece within a clearly
identified sample pack of the food being produced at the time of
the test.

Where inline metal detectors are used the test piece placed in
the product flow wherever this is possible.

The company establish and implement corrective action and

reporting procedures in the event of the testing procedure
identifying any failure of the foreign body detector. Action
include a combination of isolation, quarantining, and re- 5 5
inspection of all product produced since the last successful test.
The type, location, and strength of magnets fully documented.
Documented procedures in place for the inspection, cleaning,
strength testing, and integrity checks. Records of all checks
maintained.

Each unit checked in accordance with the manufacturer's

instructions or recommendations. Checks documented.

Based on risk assessment, procedures implemented to

minimize foreign body contamination originating with the
packaging container (e.g., jars, cans, and other preformed rigid
containers ). This may include the use of covered conveyors,
container inversion, and foreign body removal through rinsing 5 5
with water or air jets.

The effectiveness of the container cleaning equipment checked

and recorded during each production. Where the system
incorporates a rejection system for dirty or damaged containers,
the check incorporate a test of both the detection and effective 5 3
rejection of the test container.

Documented cleaning procedures in place and maintained for

the building, plant, and all equipment. Cleaning procedures as
a minimum include the:
- Responsibility for cleaning

- Item/area to be cleaned

- Frequency of cleaning

- Method of cleaning, including dismantling equipment for

cleaning purposes where required
5 4
- Cleaning chemicals and concentrations

- Cleaning materials to be used

- Cleaning records and responsibility for verification/

The frequency and methods of cleaning based on risk.

The procedures implemented to ensure appropriate standards

of cleaning are achieved.
Limits of acceptable and unacceptable cleaning performance
defined, based on the potential hazards (e.g., microbiological,
allergen, or foreign body contamination). Acceptable levels of
cleaning may be defined by visual appearance, ATP
bioluminescence techniques (see Glossary), microbiological
testing, or chemical testing as appropriate. The cleaning and 5 5
disinfection procedures and frequency validated and records
maintained.

The resources for undertaking cleaning available. Where it is

necessary to dismantle equipment for cleaning purposes or to
enter large equipment for cleaning, this appropriately
scheduled and, where necessary, planned for nonproduction
periods. Cleaning staff adequately trained or engineering
support provided where access within equipment is required for 5 5
cleaning.

The cleanliness of equipment checked before equipment is

released back into full production. The results of checks on
cleaning, including visual, analytical, and microbiological checks,
recorded and used to identify trends in cleaning performance
and instigate improvements where required. 5 5

Cleaning equipment :

- Fit for purpose

- Suitably identified for intended use, e.g., color coded or labeled

- Cleaned and stored in a hygienic manner to prevent 5 3

contamination.

Equipment used for cleaning in high-care and high-risk areas

dedicated for use in those areas.
Cleaning-in-place (CIP) facilities, where used, monitored and
maintained to ensure their effective operation.
5 5

A schematic plan of the layout of the CIP system available.

There an inspection report or other verification that:

- Systems are hygienically designed with no dead areas, limited

interruptions to flow streams, and good system drain ability

- Scavenge pumps are operated to ensure that there is no

buildup of cleaning fluids in the vessels

- Spray balls effectively clean vessels by providing full surface 5 3

coverage and are periodically inspected for blockages. Rotating
spray devices should have a defined operational time

- CIP equipment has adequate separation from active product

lines, e.g., through the use of double seat valves, manually
controlled links, or blanks in pipework.

The system revalidated following alterations or additions to the

CIP equipment. A log of changes to the CIP system
maintained.

The CIP equipment operated to ensure effective cleaning is

carried out:
- The process parameters, time, detergent concentrations, flow
rate, and temperatures defined to ensure removal of the
appropriate target hazards, e.g., soil, allergens, vegetative
-microorganisms,
Detergent concentrations
spores. Thischecked routinely.
validated and records of the
validation maintained.
5 4
- Process verification undertaken by analysis of rinse waters
and/or first product through the line for the presence of cleaning
fluids or by tests of ATP (bioluminescence techniques) allergens
-orDetergent tanks kept
micro-organisms stocked up and a log maintained of
as appropriate.
when these are filled and emptied. Recovered prerinse solutions
monitored for a buildup of carryover from the detergent tanks.
- Filters, where fitted, cleaned and inspected at a defined
frequency.
Where licensing is required for the disposal of categorized
waste, it removed by licensed contractors and records of
disposal maintained and available for audit. 5 5
Food products intended to be supplied for animal feed
segregated from waste and managed in accordance with
5 5
relevant legislative requirements.

External waste collection containers and rooms housing waste

facilities managed to minimize risk. These :

- Clearly identified

- Designed for ease of use and effective cleaning

5 3
- Well-maintained to allow cleaning and, where required,
disinfection
- Emptied at appropriate frequencies

- Covered or doors kept closed as appropriate.

If unsafe products or substandard trademarked materials are

transferred to a third party for destruction or disposal, that third
party a specialist in secure product or waste disposal and
provide records which include the quantity of waste collected for 5 5
destruction or disposal.

The company either contract the services of a competent pest

control organization, or have appropriately trained staff, for the
regular inspection and treatment of the site to deter and
eradicate infestation. The frequency of inspections determined
by risk assessment and documented. Where the services of a
pest control contractor are employed, the service contract 5 5
clearly defined and reflect the activites of the site.

Where a company undertakes its own pest control, it able to

effectively demonstrate that:
- Pest control operations are undertaken by trained and
competent staff with sufficient knowledge to select appropriate
pest control chemicals and proofing methods and understand
-the
Sufficient resources
limitations of use, are available
relevant to thetobiology
respondof to any
the infestation
pests
issues
associated with the site
5 5
- There is ready access to specialist technical knowledge when
required
- Legislation governing the use of pest control products is
understood
- Dedicated locked facilities are used for the storage of
pesticides.
Pest control documentation and records maintained. This
include as a minimum:
- An up-to-date plan of the full site identifying numbered pest
control device locations
- Identification of the baits and/or monitoring devices on site

- Clearly defined responsibilities for site management and for

the contractor 5 5

- Details of pest control products used, including instructions for

their effective use and action to be taken in case of
emergencies
- Any observed pest activity

- Details of pest control treatments undertaken.

Bait stations robust, of tamper-resistant construction, secured

in place, and appropriately located to prevent contamination risk
to product. Missing bait boxes recorded, reviewed, and
investigated. Toxic rodent baits not be used within production
areas or storage areas where open product is present except 5 5
when treating an active infestation.

Flykilling devices and/or pheromone traps correctly located and

operational. If there is a danger of insects being expelled from a
flykilling extermination device and contaminating the product,
alternative systems and equipment used. 5 5

In the event of infestation, or evidence of pest activity,

immediate action taken to eliminate the hazard. Any potentially
affected products should be subject to the nonconforming
product procedure. 5 5

Records of pest control inspections, pestproofing, and hygiene

recommendations and actions taken maintained. It the
responsibility of the company to ensure all of the relevant
recommendations made by their contractor or in-house expert
5 5
are carried out in a timely manner.
An in-depth, documented pest control survey undertaken at a
frequency based on risk, but typically quarterly by a pest control
expert to review the pest control measures in place. The timing
of the survey such as to allow access to equipment for
inspection where a risk of stored product insect infestation 5 3
exists.

Results of pest control inspections assessed and analyzed for

trends on a regular basis, but as a minimum:

- In the event of an infestation

- Annually. 5 3

This include a catch analysis from trapping devices to identify

problem areas. The analysis used as a basis for improving the
pest control procedures.

Documented procedures to maintain product safety and quality

during storage developed on the basis of risk assessment,
understood by relevant staff, and implemented accordingly.
-These
Managing chilled and
may include frozen product transfer between
as appropriate:
temperature-controlled areas
- Segregation of products where necessary to avoid cross-
contamination (physical, microbiological, or allergens) or taint 5 5
uptake
- Storing materials off the floor and away from walls

- Specific handling or stacking requirements to prevent product

damage.
Where temperature control is required, the storage area
capable of maintaining product temperature within specification
and operated to ensure specified temperatures are maintained.
Temperature recording equipment with suitable temperature
alarms fitted to all storage facilities or there a system of
recorded manual temperature checks, typically on at least a
four-hourly basis or at a frequency which allows for intervention 5 3
before product temperatures exceed defined limits for the
safety, legality, or quality of products.

Where controlled atmosphere storage is required, the storage

conditions specified and effectively controlled. Records
maintained of the storage conditions. 5 5
Where storage outside is necessary, items protected from
contamination and deterioration.
5 5

Receipt documents and/or product identification facilitate

correct stock rotation of raw materials, intermediate products,
and finished products in storage and ensure materials are used
in the correct order in relation to their manufacturing date and
within the prescribed shelf life. 5 5

Documented procedures to maintain product safety and quality

during loading and transportation developed and implemented.
These may include as appropriate:

- Controlling temperature of loading dock areas

- The use of covered bays for vehicle loading or unloading 5 5

- Securing loads on pallets to prevent movement during transit

- Inspection of loads prior to shipment

Traceability ensured during transportation. There a clear

records of shipment and receipt of goods and materials
demonstrating that sufficient checks have been completed
during the transfer of goods. 5 4

All vehicles or containers used for the shipment of products

inspected prior to loading to ensure that they are fit for purpose.
This ensure that they are:

- In a suitably clean condition

- Free from strong odors which may cuase taint to products

5 5
- Suitably maintained to prevent damage to products during
transit
- Equipped to ensure any temperature requirements can be
maintained.
Records of inspections maintained.
Where temperature control is required, the transport capable of
maintaining product temperature within specification, under
minimum and maximum load. Temperature data-logging devices
which can be interrogated to confirm time/temperature
conditions or a system to verify and record at predetermined
frequencies the correct operation of refrigeration equipment 5 5
used and records maintained.

Maintenance systems and documented cleaning procedures

maintained for all vehicles and equipment used for
loading/unloading (e.g., hoses connecting to silo installations). 5 5
There records of the meaures taken.

The company have documented procedures for the transport

of products, which include:
- Any restrictions on the use of mixed loads

- Requirements for the security of products during transit,

particularly when vehicles are parked and unattended 5 5

- Clear instructions in the case of vehicle breakdown, accident,

or failure of refrigeration systems which ensure the safety of the
products is assessed and records maintained.

Where the company employs third-party contractors, all the

requirements specified in this section clearly defined in the
contract and verified or the contracted company certificated to
the Global Standard for Storage and Distribution or similar 5 5
internationally recognized Standard.

The company provide clear guidelines on any restrictions to the

scope of new product developments to control the introduction of
hazards which would be unacceptable to the company or customers
(e.g., the introduction of allergens, glass packaging, or microbiological 5 3
risks).

All new products and changes to product formulation, packaging, or

methods of processing formally approved by the HACCP team leader
or authorized HACCP committee member. This ensure that hazards
have been assessed and suitable controls, identified through the
HACCP system, are implemented. This approval granted before
products are introduced into the factory environment. 5 3
Trials using production equipment carried out where it is necessary
to validate that product formulation and manufacturing processes are
capable of producing a safe product of the required quality.
5 5

Shelf life trials undertaken using documented protocols reflecting

conditions experienced during storage and handling. Results
recorded and retained and confirm compliance with relevant
microbiological, chemical, and organoleptic criteria. Where shelf life
trials prior to production are impractical, for instance for some long-
life products, a documented, science-based justification for the
assigned shelf life produced. 5 5

All products labelled to meet legal requirements for the designated

country of use and include information to allow the safe handling,
display, storage, preparation, and use of the product within the food
supply chain or by the customer. There a process to verify that
ingredient and allergen labelling is correct based on the product 5 5
recipe.

Where a product is designed to enable a claim to be made to satisfy a

consumer group (e.g., a nutritional claim, reduced sugar), the
company ensure that the product formulation and production
process is fully validated to meet the stated claim.
5 5

The company carry out an assessment of raw materials to establish

the presence and likelihood of contamination by allergens (refer to
Glossary). This include review of raw material specifications and,
where required, obtain additional information from suppliers, for
example through questionnaires to understand the allergen status of
the raw material, its ingredients, and the factory in which it is
produced. 5 5

The company identify and list allergen-containing materials handled

on site. This include raw materials, processing aids, intermediate,
and finished products and any new product development ingredients
or products. 5 5
A documented risk assessment carried out to identify routes of
contamination and establish documented policies and procedures for
handling raw materials, intermediate, and finished products to ensure
cross-contamination is avoided. This include:

- Consideration of the physical state of the allergenic material, i.e.,

powder, liquid, particulate 5 3
- Identification of potential points of cross-contamination through the
process flow
- Assessment of the risk of allergen cross-contamination at each
process step
- Identification of suitable controls to reduce or eliminate the risk of
cross-contamination.
Documented procedures established to ensure the effective
management of allergenic materials to prevent cross-contamination
into products not containing the allergen. This include as
appropriate:

- Physical or time segregation while allergen-containing materials are

being stored, processed, or packed
- The use of separate or additional protective over clothing when
handling allergenic materials
- Use of identified, dedicated equipment and utensils for processing
5 3
- Scheduling of production to reduce changes between products
containing an allergen and products not containing the allergen

- Systems to restrict the movement of airborne dust containing

allergenic material
- Waste handling and spillage controls
- Restrictions on food brought onto site by staff, visitors, contractors,
and for catering and cafeteria purposes.
Where rework is used, or reworking operations carried out,
procedures implemented to ensure rework containing allergens is
not used in products that do not already contain the allergen. 5 3

Where the nature of the production process is such that cross-

contamination from an allergen cannot be prevented, a warning
included on the label. National guidelines or codes of practice used
whn making such a warning statement. 5 5
Where a claim is made regarding the suitability of a food for allergy or
food sensitivity sufferers, the company ensure that the production
process is fully validated to meet the stated claim. This documented.
5 5

Equipment or area cleaning procedures designed to remove or

reduce to acceptable levels any potential cross-contamination by
allergens. The cleaning methods validated to ensure they are
effective and the effectiveness of the procedure routinely verified.
Cleaning equipment used to clean allergenic materials either be
identifiable and specific for allergen use, single use, or effectively 5 3
cleaned after use.

All relevant personnel, including engineers, temporary staff, and

contractors, have received general allergen awareness training and
be trained in the company's allergen-handling procedures.
5 3

An effective system of documented checks in place at line start-up,

and following product changeover and changes in batches of
packaging to ensure that the labels applied are correct for the
products packed. 5 5

Where claims are to be made on finished packs about the

provenance, assured, or "identity-preserved" status (see Glossary) of
raw materials used, the status of each batch of the raw material
verified and records maintained. 5 5

Where a claim is made relating to the provenance, assured, or

identity-preserved status of a product or ingredient, the facility
maintain purchasing records, traceability of raw material usage, and
final product packing records to substantiate claims. The company
undertake documented mass balance tests at least every six months
and at a frequency to meet the particular program requirements.
5 5

The process flow for the production of products where claims are
made documented and potential areas for contamination or loss of
identity identified. Appropriate controls established to ensure the
integrity of the product claims. 5 5
When purchasing or specifying food contract packaging the supplier
of packaging materials made aware of any particular characteristics
of the food (e.g., high fat content, pH, or usage conditions such as
microwaving) which may affect packaging suitability. Certificates of
conformity or other evidence available for product packaging to
confirm it conforms to relevant food safety legislation and is suitable 5 4
for its intended use.

Where appropriate, packaging stored away from raw materials and

finished product. Any part-used packaging materials suitable for use
effectively protected from contamination and clearly identified
before being returned to an appropriate storage area. Obsolete
packaging stored in a separate area and systems in place to prevent
accidental use. 5 5

Product contact liners (or raw material/work-in-progress contact

liners) purchased by the company appropriately colored and
resistant to tearing to prevent accidental contamination.
5 5

There a scheduled program of testing covering products and the

processing environment which may include microbiological, chemical,
physical, and organoleptic testing according to risk. The methods,
frequency, and specified limits documented. 5 5

Thest and inspection results recorded and reviewed regularly to

identify trends. Appropriate actions implemented promptly to
address any unsatisfactory results or trends.
5 4

The company ensure that a system of ongoing shelf-life assessment

is in place. This based on risk and include microbiological and
sensory analysis as well as relevant chemical factors such as pH and
aw. Records and results from shelf-life tests validate the shelf-life
period indicated on the product.
5 5
Pathogen testing subcontracted to an external laboratory or, where
conducted internally, the laboratory facility fully segregated from
the manufacturing site and have operating procedures to prevent any
risk of product contamination. 5 5

Where routine testing laboratories are present on a manufacturing

site, they located, designed, and operated to eliminate potential
risks to product safety. Controls documented, implemented, and
include consideration of the following:

- Design and operation of drainage and ventilation systems

- Access and security of the facility

- Movement of laboratory personnel 5 3

- Protective clothing arrangements

- Processes for obtaining product samples

- Disposal of laboratory waste

Where the company undertakes or subcontracts analyses which are

critical to product safety or legality, the laboratory or subcontractors
have gained recognized laboratory accreditation or operate in
accordance with the requirements and principles of ISO 17025.
Documented justification available where accredited methods are 5 4
not undertaken.

Procedures in place to ensure reliability of laboratory results, other

than those critical to safety and legality specified in 5.5.2.3. These
include:

- Use of recognized test methods, where available

- Documented testing procedures
- Ensuring staff are suitably qualified and/or trained and competent 5 4
to carry out the analysis required
- Use of a system to verify the accuracy of test results, e.g., ring or
proficiency testing
- Use of appropriately calibrated and maintained equipment.
Where products require positive release, procedures in place to
ensure that release does not occur until all release criteria have been
completed and release authorized.
5 3
Documented process specifications and work instructions available
for the key processes in the production of products to ensure product
safety, legality, and quality. The specifications as appropriate
include:

- Recipes - including identification of any allergens

- Mixing instructions, speed, time

- Equipment process settings

- Cooking times and temperatures 5 5

- Cooling times and temperatures

- Labeling instructions

- Coding and shelf-life marking

- Any additional critical control points identified in the HACCP plan.

Process monitoring, such as of temperature, time, pressure, and

chemical properties, implemented, adequately controlled, and
recorded to ensure that product is produced within the required 5 5
process specification.

In circumstances where process parameters are controlled by inline

monitoring devices, these linked to a suitable failure alerty system
that is routinely tested.
5 5

Where variation in processing conditions may occur within

equipment critical to the safety or quality of products, the processing
characteristics validated at a frequency based on risk and
performance of equipment (e.g., heat distribution in retorts, ovens,
and processing vessels; temperature distribution in freezers and cold
stores). 5 5

In case of equipment failure or deviation of the process from

specification, procedures in place to establish the safety status and
quality of the product to determine the action to be taken.
5 5
Documented checks of the production line carried out before
commencing production and following changes of product. These
ensure that lines have been suitably cleaned and are ready for
production. Documented checks carried out at product changes to
ensure all products and packaging from the previous production have
been removed from the line before changing to the next production. 5 3

Documented procedures in place to ensure that products are packed

into the correct packaging and correctly labelled. These include
checks at the start of packing, during the packaging run, following
packaging changes, and when changing batches of packaging
materials, in order to ensure that correct packaging materials are
used. The procedures also include verification of any code
information or other printing carried out at the packing stage. 5 5

The frequency and methodology of quantity checking meet the

requirements of appropriate legislation governing quantity
verification, and records of checks maintained.
5 5

Where the quantity of the product is not governed by legislative

requirements (e.g. bulk quantity), the product must conform to
customer requirements and records maintained.
5 5

The company identify and control measuring equipment used to

monitor CCPs, product safety, and legality.
This include as a minimum:
- A documented list of equipment and its location

- An identification code and calibration due date 5 4

- Prevention from adjustment by unauthorized staff

- Protection from damage, deterioration, or misuse.

All identified measuring devices, including new equipment, checked

and where necessary adjusted:
- At a predetermined frequency, based on risk assessment
- To a defined method traceable to a recognized national or
international Standard where possible. 5 5
Results documented. Equipment readable and be of a suitable
accuracy for the measurements it is required to perform.
Reference measuring equipment calibrated and traceable to a
recognized national or international Standard and records
maintained. 5 5

Procedures in place to record actions to be taken when the

prescribed measuring and monitoring devices are found not to be
operating within specified limits. Where the safety or legality of
products is based on equipment found to be inaccurate, action to be
taken to ensure at-risk product is not offered for sale. 5 5

All relevant personnel, including temporary staff and contractors,

appropriately trained prior to commencing work and adequately
supervised throughout the working period. 5 3

Where personnel are engaged in activities relating to critical control

points, relevant training and competency assessment in place.
5 3

The company put in place documented programs covering the

training needs of relevant personnel. These include as a minimum:

- Identifying the necessary competences for specific roles

- Providing training or other action to ensure staff have the necessary 5 3
competences
- Reviewing the effectiveness of training
- The delivery of training in the appropriate language of trainees.

Records of all training available. This include as a minimum:

- The name of the trainee and confirmation of attendance

- The date and duration of the training

- The title or course contents, as appropriate 5 4
- The training provider.
Where training is undertaken by agencies on behalf of the company,
records of the training available.
The company routinely review the competences of its staff. As
appropriate, it provide relevant training. This may be in the form of
training, refresher training, coaching, mentoring, or on-the-job
experience. 5 3

The requirements for personal hygiene documented and

communicated to all personnel. This include as a minimum the
following requirements:

- Watches not be worn

- Jewelry not be worn, with the exception of a plain wedding rign or
wedding wristband
5 3
- Rings and studs in exposed parts of the body, such as ears, noses, 5 3
tongues, and eyebrows, not be worn

- Fingernails kept short, clean, and unvarnished. False fingernails

not be permitted

- Excessive perfume or aftershave not be worn.

Compliance with the requirements checked routinely.

Hand cleaning performed on entry to the production areas and at a

frequency that is appropriate to minimize the risk of product
contamination. 5 3

All cuts and graces on exposed skin covered by an appropriately

colored plaster that is different from the product color (preferably
blue) and containing a metal detectable strip. These company issued
and monitored. Where appropriate, in addition to the plaster, a glove
worn. 5 5

Where metal detection equipment is used, a sample from each batch

of plasters successfully tested through the equipment and records
kept. 5 5

Processes and written instructions for staff in place to control the

use and storage of personal medicines, so as to minimize the risk of
product contamination. 5 3

The company have a procedure which enables notification by

employees, including temporary employees, of an relevant infection,
disease, or condition with which they may have been in contact or be
suffering from. 5 5

Where there may be a risk to product safety, visitors and contractors

required to complete a health questionnaire or otherwise confirm
that they are not suffering from a condition which may put product
safety at risk, prior to entering the raw material, preparation,
processing, packing, and storage areas. 5 3

There documented procedures for employees, contractors, and

visitors, relating to action to be taken where they may be suffering
from or have been in contact with an infectious disease. Expert
medical advice sought where required. 5 5
The company document and communicate to all employees,
contractors, or visitors the rules regarding the wearing of protective
clothing in specified work areas (e.g., high-care or low-risk areas). This
also include policies relating to the wearing of protective clothing
away from the production environment (e.g., removal before
entering washrooms, lunchrooms and smoking areas). 5 3

Protective clothing available that:

- Is provided in sufficient numbers for each employee
- Is of suitable design to prevent contamination of the product (as a
minimum containing no external pockets above the waist or sewn-on
buttons)
5 3
- Fully contains all scalp hair to prevent product contamination

- Includes snoods for beards and moustaches where required to

prevent product contamination.

Laundering of protective clothing take place by an approved

contracted or in-house laundry using defined and verified criteria to
validate the effectiveness of the laundering process. Washing of
workwear by the employee is exceptional but acceptable where the
protective clothing is to protect the employee from the products
handled and the clothing is worn in enclosed product or low-risk 5 3
areas only.

Where protective clothing for high-care or high-risk areas is provided

by a contracted laundry, this audited either directly or by a third
party, or should have a relevant certification. The laundry must
operate procedures which ensure:

- Effective cleaning of the protective clothing 5 3

- Clothes are commercially sterile following the washing and drying
process
- Adequate segregation between dirty and cleaned clothes
- Cleaned clothes are protected from contamination until delivered to
the site, e.g., by the use of covers or bags.
If gloves are used, they replaced regularly. Where appropriate,
gloves suitable for food use, of a disposable type, of a distinctive
color (blue where possible), be intact, and not shed loose fibers.
5 3
Where items of personal protective clothing that are not suitable for
laundering are provided (such as chain mail, gloves, and aprons),
these cleaned and sanitized at a frequency based on risk. 5 5

The company undertake a documented risk assessment of

each raw material or group of raw materials to identify
potential risks to product safety, legality, and quality. This take
into account the potential for:

- Allergen contamination
- Foreign body risks
- Microbiological contamination 5 5
- Chemical contamination.
Consideration also be given to the significance of a raw
material to the quality of the final product.
The risk assessment form the basis for the raw material
acceptance and testing procedure and for the processes
adopted for supplier approval and monitoring.
The company have a documented supplier approval and
ongoing monitoring procedure to ensure that suppliers are
manufacturing products under hygienic conditions, effectively
manage risks to raw materials quality and safety, and are
operating effective traceability processes. The approval and
monitoring procedure based on one or a combination of:

- Supplier audits 5 3

- Third-party audits or certification, e.g., to BRC Global

Standards
- Supplier questionnaires.

Where approval is based on questionnaires, these reissued at

least every three years and suppliers required to notify the site
of any significant changes in the interim.
The procedures define how exceptions are handled (e.g.,
where raw material suppliers are prescribed by a customer or
where products are purchased from agents and direct audit or
monitoring has not been undertaken). 5 5
The company have a documented procedure for the
acceptance of raw materials and packagin gon receipt based
upon the risk assessment (3.5.1). Raw materials acceptance and
its release for use based on one or a combination of:

- Visual inspection on receipt

- Certificates of conformance - specific to each consignment 5 4

- Certificates of analysis
- Product sampling and testing.
A list of raw materials and the requirements to be met for
acceptance available. The parameters for acceptance and
frequency of testing clearly defined.
The procedures fully implemented and records maintained to
demonstrate the basis for acceptance of each batch of raw 5 4
materials.
There a documented procedure for the approval and
monitoring of suppliers of services. Such services include as
appropriate:
- Pest control
- Laundry services
- Contracted cleaning
- Contracted servicing and maintenance of equipment 5 5
- Transport and distribution
- Off-site storage of ingredients, packaging, or products
- Laboratory testing
- Cafeteria services
- Waste management.
Contracts or formal agreements exist with the suppliers of
services which clearly define service expectations and ensure
potential food safety risks associated with the service have 5 4
been addressed.

The company able to demonstrate that, where part of the

production process is outsourced and undertaken off site, this has
been declared to the brand owner and, where required, approval
granted. 5 5

The company ensure that subcontractors are approved and

monitored by successful completion of either a documented site
audit or third-party certification to the BRC Global Standard for Food
Safety or other GFSI-recognized Standard (see Glossary). 5 5
Any outsourced processing operations :

- Be undertaken in accordance with established contracts which

clearly define any processing requirements and product specification
5 5

- Maintain product traceability

The company establish inspection and test procedures for

outsourced product on return, including visual, chemical, and/or
microbiological testing, dependent on risk assessment. 5 5
Document No.

Rev. No.:
Rev. Date :

Remark
Sr. no. Requirement

1 External Standards
2 Security
3 Layout, Product Flow and segregation
4 Building fabric
5 Utiliti4s – water, ice, air and other gases
6 Equpment
7 Maintenance
8 Staff facilities
9 Chemical and physical product contamination
10 Metal Control
11 Glass, brittle plastic, ceramics and similar materials
12 Products Packed into glass or other brittle containers
13 Wood
14 Foreign body detection and removal equipment
15 Filters and sieves
16 Metal detectors and X-ray equipment
17 Magnets
18 Optical sorting equipment
19 Container cleanliness – glass jars, cans and other rigid containers
20 Housekeeping and hygiene
21 Cleaning in place (CIP)
22 Waste/ waste disposal
23 Pest Control
24 Storage Facilities
25 Dispatch and transport
26 Product Control ( Product design / development)
27 Product Control ( Management of Allergens )
Product Control ( Provenance, assured status and claims of identity preserved
28 material)
29 Product Control (Product Packaging )
30 Product Packaging ( Product inspection and testing )
31 Product Control ( Laboratory testing )
32 Product Control ( Product release )
33 Process Control ( Control of Operations )
34 Process Control ( Quantity – Weight, Volume, and Number Control )
35
Process Contrl ( Calibration and Control of Measuring and Monitoring Devices )
36 Personnel - TRAINING (RAW MATERIAL HANDLING, PREPARATION,
PROCESSING, PACKING, AND STORAGE AREAS)
37 PERSONAL HYGIENE (RAW MATERIALS HANDLING, PREPARATION,
PROCESSING, PACKING, AND STORAGE AREAS)
38 MEDICAL SCREENING
39
PROTECTIVE CLOTHING (EMPLOYEES OR VISITORS TO PRODUCTION AREAS)
40
SUPPLIER AND RAW MATERIAL APPROVAL AND PERFORMANCE MONITORING
41 RAW MATERIAL AND PACKAGING ACCEPTANCE AND MONITORING
PROCEDURES
42 MANAGEMENT OF SUPPLIERS OF SERVICES
43 MANAGEMENT OF OUTSOURCED PROCESSING
Achieved Total Risk
PRP Risk PRP Risk Total Risk %
% Count
73.33 Medium Risk
80.00 Medium Risk High risk 6 14.63
67.50 High Risk Medium risk 18 43.90
76.92 Medium Risk Low Risk 17 41.46
100.00 Low Risk Total 41 100.00
100.00 Low Risk
83.33 Medium Risk Achieved PRP %
70.00 Medium Risk 120.00

80.00 Medium Risk 100.00

60.00 High Risk 80.00
93.33 Low Risk
60.00
73.33 Medium Risk
80.00 Medium Risk 40.00
90.00 Low Risk 20.00
60.00 High Risk
0.00
100.00 Low Risk
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
80.00 Medium Risk
88.00 Medium Risk
80.00 Medium Risk
90.00 Low Risk
91.11 Low Risk
92.00 Low Risk
97.14 Low Risk
86.67 Medium Risk
80.00 Medium Risk
100.00 Low Risk
93.33 Low Risk
93.33 Low Risk
80.00 Medium Risk PRP Chart
60.00 High Risk
94.29 Low Risk
100.00 Low Risk High risk
15%
95.00 Low Risk

64.00 High Risk Low Risk

41%

Medium risk
44%
 15%

Low Risk
41%
76.00 Medium Risk
86.67 Medium Risk
Medium risk
66.67 High Risk 44%

86.67 Medium Risk

80.00 Medium Risk

90.00 Low Risk
100.00 Low Risk
 Achieved PRP %

Achieved %

Linear
(Achieved
%)

igh risk
15%

Medium risk
44%
15%

Medium risk
44%