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Technical Report: (5205)147-0303 May 27, 2005

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JIM LOW
KRAFT FOODS, INC.
100 DEFOREST AVE
EAST HANOVER, NJ 07936
UNITED STATES

SUBJECT:

nd
Factory 2 re-audit of the Hai Jin Plastic Goods Factory (Third Industrial District, Cheung Tong Factory Zone, Tai
Long, Dong guan) on May 26, 2005 for the Kraft Lifesavers Holiday Roll-Toppers On-pack program.

EXECUTIVE SUMMARY:

PASS

The score of this audit is 90.51, which meet the requirements of a minimum of 90 points out of 100 possible points.

The conditions observed during the factory audit are detailed in the following pages.

BUREAU VERITAS HONG KONG LIMITED

Gary Chiu, Manager


Premiums Department
Consumer Products Division
GC/wk

cc: FANNY NG, CREATIVE WERKS ASIA LTD.


LARRY STAKAL, CREATIVE WERKS, LLC.
RUSS MUTH, CREATIVE WERKS, LLC.
KARIN JENSEN, KRAFT FOODS, INC.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 2 of 16

EXECUTIVE SUMMARY

The major business of the factory was blow-molded products. The factory composed of three main buildings for
production. Factory had approximate 550 workers.

For further improvement, please see below recommendations for relevant criteria:

Pest control factory shall further enhanced the pest control procedures, which include the name of pesticide.
Trend analysis and follow up corrective actions should be documented in trend analysis reports.

Sanitation all cleaning equipment should be stored and secured to prevent unauthorized use.

Operation and Facility 18 inspection perimeter should be kept for all production materials. Containers should be
properly labeled for identification purpose. Toilet should be cleaned up properly.

Good Manufacturing Practices Workers should wear hairnets completely in the production area. Toilet should be
clean up properly.

Quality and Document Control All sensitive and proprietary document should have the following verbiages printed
on all pages: Do not Duplicate Proprietary information and Do not Remove from Facility.

Quality Enhancements Training Program of Food, New Technology and Customer Awareness should be
established and implemented.

Process Control FMEA should be established and implemented Statistical methods should be understood and
used effectively to control and improve the production process.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 3 of 16

Premium Quality Audit

Supplier: Hai Jin Plastic Goods Factory Auditor(s): Charles Leung

Plant: Third Industrial District, Supplier Representative: Cheng Ping QC


Cheung Tong Factory Zone, Supervisor, Hai Jin
Tai Long, Dong guan Plastic Goods Factory

Audit Date: 27 May, 2005

Last Audit Date: 10 May, 2005

Previous Audit Score: 62.92

Score Summary:

Criteria Score Weight (%) Weighted Score


1. Pest Control 87.5 5 4.38
2. Sanitation 100 10 10
3. Operations and Facility 75 10 7.5
4. Good Manufacturing Practices 91.7 10 9.17
5. Quality and Document Control 100 5 5
6. Product and Material Tracking 100 15 15
7. Purchasing and Control of Incoming Materials 100 15 15
8. Quality Enhancements 75 5 3.75
9. Control of Nonconforming Products 100 10 10
10. Process Control 71.4 15 10.71
Total Points 100 90.51

PASS/FAIL CRITERIA: Pass/Fail Criteria of Factory audit is 90 points out of 100 points.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 4 of 16

PREMIUM QUALITY AUDIT

1.0 PEST CONTROL YES NO COMMENTS


1.1 A documented pest control program has been There was pest control program that
established. included a designated pest control operator
(PCO), scheduled service intervals and
location of traps and name of pesticides.
But, one name of pesticides was not
defined in the pest control program.
1.2 Pesticides are approved by the appropriate All pesticides have multilingual MSDS.
regulatory agency. Handling procedures and
storage policy are on file.
1.3 PCO service reports, including usage logs, Pest control service reports were
are current and available for review. documented. Internal audit was conducted
after pest control activity.

1.4 There is a pest activity trend report with Trend analysis was not conducted based
corrective action identified. on the pest activity. Corrective actions were
not documented.
1.5 There is no evidence of pest activity.
1.6 All pest control devices are located in such a
manner as to not contaminate premiums,
packaging materials, or equipment.
1.7 The number and placement of traps and bait
stations is documented and effective.
1.8 Bait stations are secured and tamper
resistant.
2.0 SANITATION YES NO COMMENTS
2.1 Cleaning chemicals and sanitizers are MSDS of all sanitizers and cleaning agent
approved by the appropriate regulatory were available in factory.
agency, and data sheets are available.
2.2 Cleaning equipment and chemicals are Cleaning equipment were stored in locked
properly stored. room and cleaned properly before storage.
One instance of cleaning equipment was
stored in toilet, which was not secured.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 5 of 16

3.0 OPERATIONS AND FACILITY YES NO COMMENTS


3.1 Procedures for periodic facility inspections
(including production areas, non-production
areas, and surrounding grounds) have been
established. Records are maintained.
3.2 Housekeeping/ Facility upkeep is acceptable
for walls, floors, ceilings, and grounds.
3.3 Air ventilation through the facility is adequate.
3.4 Facility repairs are complete with no
temporary repair materials used.
3.5 Lights and other breakable materials are
shielded to prevent potential contamination.
3.6 Break areas, locker rooms, rest rooms, and Toilet in the 3 rd floor (paint spraying
wash stations are maintained in a clean and area) was not cleaned properly.
orderly manner.
3.7 Waste materials and process build up are
removed promptly and properly disposed of.
3.8 Doors and opening are pest resistant. Cracks
and crevices have been sealed.
3.9 Idle equipment and spare parts are properly
cleaned and stored.
3.10 All areas are free from potentially hazardous
materials that may contaminate premium
material.
3.11 All containers are properly labeled. Many instances of containers in the
paint spraying area were not properly
labeled.
3.12 A minimum 18 (45cm) inspection perimeter is Many instances of work-in-progress
maintained through the storage facilities. (spraying parts) in the paint spraying
area were not maintained 18 inches
inspection perimeter.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 6 of 16

4.0 GOOD MANUFACTURING PRACTICES YES NO COMMENTS


4.1 Good Manufacturing Practices program is GMP Program was documented that
established (including visitor and training included visitor and self-audit program.
programs).
4.2 GMP self-audits are conducted monthly and GMP Self-audits conducted every
include corrective action. month. Audit records were kept for
review.
4.3 Do employees in production area wear hair Some workers not wearing hairnets
nets or other effective hair covering? completely in the production areas.
4.4 Do employees with beards wear beard NA NA Not applicable. No employee with
covering in the production area? beards in the production area.
4.5 Are there adequate facilities available for Liquid hand soap and air dryer was
hand washing? installed in the washrooms that nearby
the blow molding area, paint spraying
area and final pack out area.
4.6 Are toilets, urinals, and washing stations Drain was conducted by automatic
clean and in good working order? flushing in the washroom that nearby
the blow molding area, paint spraying
area and final pack out area.

4.7 Are towels or air dryers adequate for the Liquid hand soap and air dryers were
facility? installed in the toilets that nearby the
bold molding area paint spraying area
and final pack out area.
4.8 Are eating, drinking, smoking, or gum
chewing prohibited and unobserved in the
production area?
4.9 Personal items are stored away from
processing areas.
4.10 Medical problems are not a source of
contamination.
4.11 Hand washing facilities are available, have Automatic stopped hand wash device
clean running water, are stocked, clean and and hand soap was installed in all
are being used. washing facility.
4.12 Signs supporting GMPs are posted
appropriately.
4.13 Work areas are orderly with tools and
processing supplies properly stored.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 7 of 16

5.0 QUALITY AND DOCUMENT CONTROL YES NO COMMENTS


5.1 Laboratory and testing procedures are
established for specification criteria.
5.2 Individuals are formally trained to conduct
assigned testing and QA evaluations.
Competencies should be assessed.
5.3 Procedures for control of specifications and Procedures for control of specifications
processes are established. and proprietary information were
established. Records were maintained.
But, require wording Do Not Duplicate-
Proprietary Information and Do Not
Remove from Facility was not printed in
all pages of proprietary documents.
5.4 Controlled documents are secured and
access is restricted.

6.0 PRODUCT AND MATERIAL TRACKING YES NO COMMENTS


6.1 A documented recall/ withdrawal program is
established.
6.2 Procedures for lot identification and tracking Procedures for lot identification and
for all raw materials, packaging materials and tracking for raw materials, packaging
finished product are established. Records are materials and finished product was
maintained. established. Specified code was defined
for the Identification of raw materials and
final product.

6.3 Procedures are established to track and


control all reworked and work in progress.

6.4 Supplier can identify, track ingredients to Annual mock recall program was
finished product lots and locate finished conducted by factory. 100% finished
product lots to first external customer within product has been tracked and retrieved
specified amount of time. The compliance is within 4 hours.
verified by annual mock recall program. But, one instance of incomplete record
was found.
6.5 Finished products, packaging and raw
materials are properly identified for tracking
purposes.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 8 of 16

7.0 PURCHASING AND CONTROL OF YES NO COMMENTS


INCOMING MATERIALS
7.1 Specifications/ quality requirements for all raw
materials are maintained.
7.2 Procedures for inspection, approval and
disposition of raw materials and packaging
materials are established.
7.3 An approved supplier program is established
for all raw materials and packaging materials.
This should include periodic verification of
compliance to specification(s).
8.0 QUALITY ENHANCEMENTS YES NO COMMENTS
8.1 A program for continuous improvement of Continuous improvement program for
quality and productivity is established. quality and productivity was established.
Records are maintained. Records were kept for review.
8.2 Records verify internal assessments are
conducted by qualified, independent auditors.
8.3 An ongoing training program for all facility Training program was established for
employees with regard to GMPs, Food and Worker Safety, GMP and Quality topic
Worker Safety. Quality and Customer only.
Awareness is established. But, the training program of Food, New
Technology and Customer Awareness
was not established. Training record did
not exist.
8.4 No unsafe work practices are observed.
9.0 CONTROL OF NON-CONFORMING YES NO COMMENTS
PRODUCTS
9.1 Facility has established procedures for the
identification, segregation and disposition of
non-conforming raw material, packaging and
finished product. Records are maintained.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 9 of 16

10.0 PROCESS CONTROL


10.1 A Failure Mode and Effect Analysis has been Failure mode and Effect analysis program
conducted and is available for review. (See was not established. Records did not
attached.) exist.
10.2 Control Plan is available for review. (See Control plan was established and
Attached.) implemented. Critical process parameter
(e.g. blow molding temperature) was set
up and monitored.
10.3 Specific work instructions (Standard Operated
Procedures) for key equipment and process
settings are established.
10.4 There are documented job descriptions and
qualifications. Training programs are
established.
10.5 Procedures are established, including Procedure of equipment calibration was
schedules and frequency, for the calibration established and calibration records were
and accuracy of key measurement and testing maintained.
equipment, for labs, QA and manufacturing.
Records are maintained.
10.6 A preventative maintenance program is
established. Records are maintained.
10.7 Statistical methods are understood and used SPC was not established and
effectively to control and improve production implemented.
process.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 10 of 16

PICTURES:

Facilities in Hai Jin Plastic Goods Factory

Workers not
wearing
hairnet
completely

Sharp tool was


on work bench

Photo 1 Photo 2

Factory outlook Processing Area Worker not wore hairnet


completely. Hair was exposed.

Light with light Traps was located on


shield exterior of buildings.

Photo 3 Photo 4

Final product warehouse- Light with light shield. Final product warehouse Traps was located on
exterior of buildings.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 11 of 16

Worker not wore hairnet


completely

Photo 5 Photo 6

Blow molding area door was closed Blow Molding Trimming Area Worker not wore
hairnet completely.

Cleaning equipment
was stored in locked
Light with light shielding room to prevent
unauthorized use

Photo 7 Photo 8

Blow molding Trimming area light with light Cleaning equipment was stored in locked room to
shielding. prevent unauthorized use.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 12 of 16

Hand wash facility Push water flushing device was


was installed with Hand installed in toilet nearby the blow
automatic stopped dryer was molding area
device installed

Hand soap was


existed

Photo 9 Photo 10

Toilet nearby the blow molding area- Hand wash Toilet nearby the blow molding area Push water
facility was installed automatic stopped device. Hand flushing device was installed.
soap was existed. Hand dryer was installed.

One
Cleaning
equipment
were Liquid soap Hand dryer
segregated
but not
secured

Hand wash facility


was installed
automatic stopped
device

Photo 11 Photo 12

Production area one instance of cleaning equipment Toilet in Pack out area - Hand wash facility was
were segregated (stored in toilet) but not secured. installed automatic stopped device. Hand soap and
hand dryer was existed.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 13 of 16

Cleaning chemicals with Mult-lingiual


MSDS

Sanitizer for
hand dip
Pesticides with Mult-
lingiual MSDS

Photo 13 Photo 14

Final pack out area sanitizer for hand dip. Cleaning chemicals and pesticides with MSDS.

Calibration Working
log label instruction
was
attached.

Photo 15 Photo 16

Measuring equipment was calibrated. This equipment Final pack out area.
was not calibrated in previous audit.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 14 of 16

UV
Sanitizer for hand Light with tunnels
dip Light shield

Photo 17 Photo 18

Final pack out area sanitizer for hand dip. Final pack out area.

Light with
Light
shield

Worker not wore


hairnet completely.
Hair was exposed.

Photo 19 Photo 20

Final pack out area. Paint spraying area worker not wore hairnet
completely. Hair was exposed.
KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 15 of 16

WIP were not stored


away 18 inches from Containers without
walls label for identification.

Photo 21 Photo 22

Paint Spraying area spraying parts were not stored Paint touch up area many containers without label
away from walls. for identification.

Window
with
screened

Photo 25 Photo 26

Paint Spraying area window was screened Raw material warehouse.


KRAFT FOODS, INC.
Technical Report: (5205)147-0303
May 27, 2005
Page 16 of 16

Toilet was not


cleaned work-in-progress (paint parts)
were placed in normal
environment (without fan) for
aireation process

Photo 27 Photo 28

Toilet which nearby the paint spraying area was not Paint spraying area work-in-progress (paint parts)
cleaned properly were placed in normal environment for aireation
process.

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