奇华顿审核清单 中英文对照版_图文

Vendor Audit Form

Vendor Company Name:

Vendor Site Address:

County / Postal Code:

Country:

Phone:

Vendor Internet Page:

Sanitary Approval / FDA Number:

Additional Company Details:

Type/category of material(s) delivered for Givaudan:

(List of supplied material group codes at the date of audit shall be enclosed in sepera

Contact Information:Name / SurnamePhone

Commercial Contact

Production

Quality (Audit Follow-up)

Emergency 24 h Contact

To be completed by Givaudan

Givaudan Auditor Team:

FunctionName / SurnamePhone

Vendor qualification:

Vendor Site Audited:

Date of Audit:

SAP Vendor Code:

no

Approval Restrictions:

yes, see additional comments page 9

Vendor Status:NOT APPROVED

CONDITIONALLY APPROVED

Vendor Confidence Level:APPROV

Material Risk Classification:PREFER

Rating % Total Vendor Audit Form Elements:

0%

Rating % Vendor Audit Form Core Elements:

0%

Date / Version: 21.05.10 / 3.2Page 1/24

Replaces Date / Version: 06.01.10 / 3.1

Established by: QM EAME

Vendor Audit Form

1. Quality Management System

N°Core

Element

WeightYesNo

Is the site certified for any quality, food

1.1yessafety or sustainability standards (e.g. ISO,400

IFS, BRC, AIB)?

Does the site have a documented quality

1.2system to ensure compliance with all200

customer and regulatory requirements?

1.3

Does all staff have easy access to the

documented quality systems?

200

1.4yes

Is there an internal quality system audit

program in place?

200

1.5

nfr

yes

Is there an internal GMP and hygiene

inspection program in place?

200

Is there a management of change procedure

1.6yes

in place for changes to product formulation,

specifications, processing methods,

200

equipment or packaging?

Have all production processes (from raw

material purchase, the production process,

1.7

storage and dispatch) been subject to

nfr

yes

HACCP study and are hazard analyses

400

established for possible biological, physical

and chemical risks in accordance to

principles of Codex Alimentarius?

1.8Have you included allergens as part of your

nfrHACCP plan?

200

1.9

Have comprehensive flow charts and CCP

nfr

control measures (incl. critical limits) of the200

process been developed?

1.10Are documentation and records of the CCP

nfrmonitoring available?

200

1.11

Is a verification procedure of the HACCP

nfr

system implemented (e.g. audits, micro-200

tests)?

1.12

nfr

yes

Is the HACCP system subject to regular

review and update?

200

1.13

nfr

yes

Are operators trained in HACCP including

the relevant CCP's?

200

Is each customer complaint investigated and

1.14

recorded to determine the root cause and

corrective actions developed to prevent

200

reoccurrence?

1.15

Are all corrective and preventive actions

systematically followed up and approved ?

200

1.16

Are facilities approved for Kosher and/or

Halal production?

000

1.17

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

3400

Date / Version: 21.05.10 / 3.2Page 2/24

Replaces Date / Version: 06.01.10 / 3.1

Established by: QM EAME

Vendor Audit Form

2. Raw- / Packaging Material & Vendor Management

N°Core

Element

WeightYesNo

Is there a documented vendor approval

2.1yessystem that includes food safety focused200

audits?

Are all appropriate specifications and

2.2regulatory documents maintained and200

updated for purchased raw materials?

2.3

Does your facility use or store any allergenic

nfr

ingredients or products?

000

2.4

yes

Are all allergenic products clearly labeled as

nfrsuch?

200

2.5

nfr

yes

Are allergenic products kept segregated from

non allergenic products?

200

2.6

Are specific procedures in place to prevent

nfr

cross contamination of GMO ingredients with200

GMO free products?

2.7

Is the water for food processing and cleaning

nfr

regularly monitored (pathogens,200

contaminants)?

Is there a comprehensive goods receipt

procedure established for all raw and

2.8yes

packaging materials that covers hygienic

status, tamper evidence, intactness, if

200

required temperature and labeling of

delivered goods?

What special procedures are there for

2.9receipts of one product which consists of two200

or more batches?

Does the goods receipt procedure include

2.10

inspection of delivery vehicle (hygiene,

cleaning certificate for bulk deliveries,

200

previous loads, security seals)?

Are sieves, filters, and magnets used and

2.11checked after the unloading of bulk200

deliveries?

Is there a positive release system with

2.12yes

restriction to designated individuals for

conforming receipts (i.e. all batches held

200

until approved by Quality Control)?

Is there a written procedure (quarantine

2.13

status, including rejection, acceptance by

concession, or alternative use) in place to

200

deal with non-conforming products?

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Vendor Audit Form

2.14

Are all rejected items clearly labeled

(physically or electronically) as such?

200

2.15

Is there a control system to assure First In -

First Out (FIFO) principles?

200

2.16

Is there a system to monitor/control expiry

dates of stored products?

200

2.17

Are raw materials stored in the correct

conditions as detailed in their specification?

200

Is the temperature of cool storage rooms

2.18monitored and is the system provided with200

an alarm?

2.19Are packaging materials kept segregated

nfrand covered before use?

200

2.20

Does all finished product packaging comply

nfr

with the regulations controlling the use of200

packaging for food products?

Are relevant packaging information available

2.21(specification, migration certificate, food200

conformity certificate)?

2.22

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

4000

3. Product Realization

N°Core

Element

WeightYesNo

Is production conducted according to fully

3.1documented working procedures and200

controlled recipes?

3.2

Are all materials and process steps clearly

identified throughout the production process?

200

3.3

Are specific procedures in place to prevent

nfr

yescross contamination of allergenic products200

with non-allergenic products?

Are for the nonconforming products and

3.4yes

rework clear procedures including material

status, rejection, acceptance by concession,

200

or alternative use, in place?

Are all finished and intermediate materials

3.5stored in the correct conditions as detailed in200

their specification?

Is any type of waste correctly handled

3.6(dedicated waste bins/bags) and marked up200

to prevent the use of unfit materials?

3.7Are all products stored inside?200

3.8

Is the labeling process documented and

controlled?

200

3.9

Are all temperature related process

parameters automatically controlled?

200

3.10

Is the accuracy required for each piece of

equipment appropriate to its function?

200

Are temperature and/or time control, critical

3.11yesto product safety or quality, monitored at an200

appropriate frequency?

3.12

Are all air filters regularly

maintained/replaced?

200

3.13

Are used process air filters of appropriate

nfr

mesh size (F10 for cold air, F7 for hot air >200

70°C)?

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Vendor Audit Form

Is there screen/sieve (CCP) with max. mesh

3.14

nfr

yes

size of 2 mm in place just before

packing/filling and checked regularly on

200

presence and integrity?

3.15Is there a metal detection/rejection system in

nfrplace?

200

3.16

Is the metal detector including response time

nfr

of alarm and/or rejection device regularly200

tested?

3.17

Do you have a weight / fill control program in

place?

200

Are all individual packages for finished

3.18yesproducts well closed and tamper evident200

sealed?

3.19

Are carrier vehicles checked for cleanliness

and suitability prior to loading?

200

Do you or your transport contractor have

procedures to prevent uncontrolled

3.20

contamination during transport and to assure

200

appropriate actions in case of vehicle or

refrigeration equipment breakdown?

Is there a positive release system for finished

3.21goods (i.e. all batches held until approved by200

Quality Control)?

3.22

Can you guarantee a remaining shelf life of

75% for supplied materials?

200

3.23

Is a certificate of analysis (CoA) supplied to

customers for each delivery?

200

3.24

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

4600

4. Prerequisite Systems

N°Core

Element

WeightYesNo

Are measures available to maintain site

4.1yes

security (e.g. restricted access to production

and warehouse, gate, fence around the

200

perimeters, cameras etc.)?

Have you carried out a product security

4.2

study according to operational risk

assessment principles (Food Defense

200

Program)?

Is there an effective segregation between

4.3yeshigh and low risk operations (e.g. hygiene200

zoning)?

Are laboratories and their activities

4.4sufficiently segregated to ensure that the200

safety of the products is not jeopardized?

Is the company's personnel hygiene

4.5standards documented and adopted by all200

personnel, including visitors to the factory?

4.6

Are smoking, drinking or eating forbidden in

the production area?

200

Is suitable and hygienic clothing supplied to

4.7

factory personnel and are outdoor clothing

and other personal items separately stored

200

from work-wear within changing facilities?

4.8Is full hair cover enforced on the site

nfrincluding beards where appropriate?

200

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Vendor Audit Form

4.9Is hygienic footwear enforced in production

nfrareas?

200

4.10Are there personnel hygiene house rules

nfrprohibiting jewelery in the production area?

200

4.11

Is there a formal health and safety program

nfr

for control of employee illness and200

communicable diseases?

4.12Is hand sanitation enforced on relevant

nfrlocations?

200

4.13

Are sufficient sanitary areas as well as

breakrooms available?

200

Are there documented cleaning and

4.14yessanitation procedures for equipment and200

production environment?

Are cleaning plans established and

4.15appropriate that cover plant, all warehouses200

and production facilities?

4.16

Is all equipment confirmed free of

contamination prior to use?

200

Are cleaning procedures validated and

4.17verified periodically for effectiveness and

nfr

yes

absence of cleaning residues (ELISA testing,

200

bioluminescence, micro swabs)?

Are all cleaning and disinfection agents

4.18properly labeled and stored in a secure and200

identified area?

4.19

Is there a designated storage location for all

cleaning tools?

200

4.20Is there a system of color coding cleaning

nfrtools?

200

Do you have a monitoring program in place

4.21

that covers air, water and swabbing of

product contact surfaces and process

200

environment?

4.22Is there an effective pest control program in

nfr

yes

place incl. insects, rodents and birds?

200

4.23Are schematics available for all flying insect

nfrlight traps, baits and other traps?

200

4.24Are traps and baits installed correctly and

nfrproperly maintained?

200

4.25Are the results of inspections and any follow-

nfrup documented?

200

4.26Is the use of toxic rodent baits prohibited in

nfrthe warehouse and production area?

200

4.27Is a pesticide usage log maintained and

nfrpesticides stored in a secure environment?

200

Is there a glass policy in place? Glass list

(Written procedures for handling glass,

4.28

ceramics, hard plastic breakage in raw

nfr

material handling, preparation, processing,

200

packing and storage areas are in place to

ensure effective precautions are taken?)

4.29Are windows and lights shatter-proof or

nfr

yes

shielded in food handling areas?

200

4.30

Does all processing equipment with direct

nfr

yesfood contact meet industry sanitary200

standards or guidelines?

4.31

Is there a preventive maintenance program

in place?

200

Are measuring devices (scales, probes,

4.32yesmetal detectors) yearly calibrated and status200

reported?

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Vendor Audit Form

4.33When doors and windows are open are

nfrscreens in place to prevent pest ingress?

200

4.34

Are toilets correctly located (toilets must not

nfr

open directly into production, packaging or200

storage areas)

Are the walls, floors, and ceilings inspected

4.35and maintained (loose paint, dirt, mould,200

other contaminants and cracks)?

4.36

If there is an insulated spray drier, is the

nfr

equipment subject to crack testing at least200

every 3 years by an independent company?

4.37Are only food grade paints and lubricants

nfrused for food contact surfaces?

200

4.38

Is there a specific air flow through the factory

nfr

(e.g. positive pressure towards the raw200

materials area)?

Are the exterior grounds well maintained and

4.39free from debris, excessive weeds, and200

standing water?

4.40

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

7800

5. Traceability & Crisis Management

N°Core

Element

WeightYesNo

Is a comprehensive system in place that

5.1yesallows full traceability for ingredients and200

finished products at all stages of process?

5.2

Is there a batch or other traceability system

controlling the use of product packaging?

200

5.3

Do you declare a unique batch code on

delivered goods?

200

Can you assure that one declared batch is

5.4

manufactured in a self contained manner

resulting in a unique and homogeneous set

200

of quality parameters?

5.5yes

Is there an appropriate and formalized recall

and crisis management procedure in place?

200

5.6

Is the recall procedure challenged at least

annually?

200

5.7

Is a contingency plan established in case of

an incident?

200

5.8

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

1400

6. Resource Management

N°Core

Element

WeightYesNo

6.1

Have appropriate introduction training

programs been established for all positions?

200

6.2

yes

Are all relevant employees formally

nfr(re)trained in GMP and HACCP?

200

6.3

Are relevant employees trained in allergen

handling?

200

6.4

Are training efficiencies evaluated (e.g. by

means of tests)?

200

6.5Is each employees training documented?200

6.6

Supplementary element/comment relevant

for auditor and audit rating

000

Date / Version: 21.05.10 / 3.2Page 7/24

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Established by: QM EAME

Vendor Audit Form

Total weighted score:

1000

7. Measurements, Analysis, Improvements

N°Core

Element

WeightYesNo

7.1

Have all test methods been documented and

formally approved?

200

Is test equipment calibrated at established

7.2yesfrequencies against recognized and traceable200

standards?

7.3

Have your methods been validated for the

intended use (e.g. by ring tests)?

200

7.4

Are any of the QC tests carried out by a third

party?

000

7.5

Are external laboratories independently

accredited by a competent body?

200

7.6

Are raw and/or finished materials subject of

nfr

yesa contaminants monitoring program (e.g.200

pesticides, heavy metals, mycotoxins)?

7.7

Are microbiological tests carried out in

nfr

accordance with internationally recognized200

standards?

7.8

Are sensory characteristics evaluated as part

of a documented testing procedure?

200

7.9

What standard is used when carrying out

sensory evaluations?

000

7.10

Are product data subject to trend analyses?

200

7.11

Supplementary element/comment relevant

for auditor and audit rating

000

Total weighted score:

1600

8. Environment, Health and Safety

8.1. EHS Organization

N°Core

Element

WeightYesNo

Is a EHS Handbook (in the local language)

8.1.1available describing EHS policy, guidelines200

and procedures?

8.1.2

Is a specific department in charge of EHS?

100

8.1.3yes

On a legal basis, is the site in compliance

with local EHS regulations?

200

Total weighted score:

500

8.2. Accident & Incident Prevention

N°Core

Element

WeightYesNo

8.2.1yes

Are accidents recorded?

200

8.2.2

Did you decrease your accident rate?

100

8.2.3

Is the accident statistic published internally?

100

Do you require work permits for activities like

8.2.4yes

hot work (welding, etc…), work in confined

200

space, etc?

For work permits, are electrical or

8.2.5mechanical devices Locked/ Taged out200

before starting?

8.2.6

Is there a written training matrix according to

the type of personnel activity?

200

Total weighted score:

1000

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Established by: QM EAME

Vendor Audit Form

Date / Version: 21.05.10 / 3.2

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Page 9/24Established by: QM EAME

Vendor Audit Form

8.3. Emergency Organization

N°Core

Element

WeightYesNo

8.3.1

Is the zone definition of the area surrounding

your site registered as industrial?

000

Is there a written procedure for detection,

8.3.2yesnotification, and engagement in cases of fire,200

spills, gas releases, alarm, etc.?

8.3.3yes

Do you have fire water reserve?

200

8.3.4

Are employees trained to operate fire

extinguishers and on emergency evacuation?

100

8.3.5

How many first aiders do you have in your

personal?

000

8.3.6

Do you have a dedicated smoking area that

are separated from the production area?

100

Total weighted score:

600

8.4. EHS Operations

N°Core

Element

WeightYesNo

8.4.1yes

Are safety and hygiene measures included in

the written operating procedures?

200

Is the use of dangerous processes (high

pressure processes, exothermic processes)

8.4.2yes

or products (high flammable gas, toxic

200

products, corrosive products..) handled

safely?

Is Fire fighting equipment

8.4.3yessufficient,accessible, in working order, and200

appropriate for use?

8.4.4

Are eyewash/shower stations available at

each factory floor and in working order?

200

8.4.5

Are evacuation plans visibly posted in local

language?

200

8.4.6

Is emergency lighting sufficiently installed?

100

8.4.7

Is there a fire alarm audible/visible

throughout?

200

Is there sufficient number of exits? And are

8.4.8yesthe exits clearly marked, unblocked and200

unlocked?

Are first aid kits

8.4.9yes

- sufficiently available and readily accessible

to employees in each Workplace at all

200

times?

Are natural risks (earthquake, storms,

8.4.10floods) in your location identified and100

adressed?

8.4.11yes

Are MSDS available for all employees in the

local language?

200

Are all drums/ containers labelled ? Are

8.4.12yespersonnel in the warehouse instructed on a200

regular basis on the label meaning?

Total weighted score:

2200

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Vendor Audit Form

8.5. Industrial Hygiene

N°Core

Element

WeightYesNo

8.5.1yes

Have workplace risk assessments already

been performed and documented?

200

8.5.2

Is a monitoring programme of air sampling

in place?

200

8.5.3

Are places where hazardous materials

handled well ventilated?

200

8.5.4yes

Is personal protective equipment available

according to the type of activity?

200

8.5.5yes

Are workers exposed to chemicals under

regular medical control?

200

8.5.6

Is there an internal full time or part time

medical services (physician and nurse)?

100

Total weighted score:

1100

8.6. Environmental Protection & Waste Management

N°Core

Element

WeightYesNo

Is there a dedicated senior management

8.6.1person responsible for the Environmental100

Management of the Facility?

Are there environmental objectives? If yes,

8.6.2are the targets specific, measurable,100

concrete and understandable?

8.6.3

Is there a legal requirements periodic

screening regarding environmental issues?

200

8.6.4yes

Is the site in compliance with the wastewater

and air emission regulations?

200

8.6.5

Is there a wastewater (physical

(neutralisation), biological, septic) treatment?

200

8.6.6

Are there complaints from the

neighbourhood?

100

8.6.7

Is the site under any consent order?

200

8.6.8

Have all waste streams of the site been

identified?

100

8.6.9yes

Are all the hazardous wastes declared

properly according to legal regulations?

200

8.6.10

How is hazardous waste disposed ?

Incinerated Landfill

000

In case of hazardous waste disposal

8.6.11yessubcontracting, does your partner have an200

official autorisation?

8.6.12

Is non-hazardous waste disposal recorded?

200

8.6.13

Is a sorting system in place for non-

hazardous waste cases?

100

Total weighted score:

1900

8.7. Security

N°Core

Element

WeightYesNo

8.7.1

Is the site controlled by guards?

200

8.7.2

Is the site fenced?

100

8.7.3

Are the personnel checked by entering and

leaving the site?

200

8.7.4

Are there different buildings with access

control?

100

Total weighted score:

600

Date / Version: 21.05.10 / 3.2Page 11/24

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Established by: QM EAME

Vendor Audit Form

Additional Comments

(E.g. processes not audited/approved, important findings)

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Vendor Audit Form

Email

Email

low

medium

high

yes

Date / Version: 21.05.10 / 3.2

Replaces Date / Version: 06.01.10 / 3.1

Established by: QM EAME

nclosed in seperate register of this file)

see additional comments page 9

NOT APPROVED

CONDITIONALLY APPROVED

Page 13/24

Vendor Audit Form

Comments

Please list certified standards:

Please describe

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Established by: QM EAMEPage 14/24

Vendor Audit Form

Management

Comments

Please delete type of allergens not stored on

your site:

- Peanut and products therof

- Tree nuts (almond, brazil, cashew, hazelnut,

macadamia nut, pecan, walnut, chestnut and pine

nut) and products therof

- Sesame seeds and products therof

- Crustaceans and products therof

- Fish and products therof

- Egg and products therof

- Milk and products therof

- Soya and products therof

- Cereals (wheat, barley, rye, oats, spelt, triticale,

kamut) and products therof

- Sulphites > 10 ppm

- Celery and products therof

- Mustard and products therof

- Lupine and products therof

- Molluscs and products thereof

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Comments

Please describe

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Comments

Please describe

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Comments

Comments

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Comments

Please describe

If yes, where?

Please describe

Comments

Comments

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Comments

Comments

please describe

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Comments

Comments

Comments

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