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英文版管理评审报告

英文版管理评审报告 本文关键词:英文版,评审,报告,管理

英文版管理评审报告 本文简介:QUALITYMANAGEMENTREVIEW管理评审报告MeetingDate:May-15,2009Time:2:00PM-4:30PMVenue:DGoffice5BconferenceroomChairperson:Attendees:MinutesThismanagementsystemr

英文版管理评审报告 本文内容:

QUALITY

MANAGEMENT

REVIEW

管理评审报告

Meeting

Date

:

May-15,2009

Time

:

2:00PM-

4:30PM

Venue

:

DG

office

5B

conference

room

Chairperson

:

Attendees:

Minutes

This

management

system

review

covers

all

XXXXXfunctions,including

the

Chemical-lab

and

Microbiological-lab.

1.

Review

the

suitability

and

effectiveness

of

quality

system

A.

External-Assessment

Results

The

external

assessments

have

not

been

conducted

through

CNAS

until

the

application

documents

have

been

gone

through

and

the

laboratory

audited

by

the

CNAS

auditors.

CDLL

chemical

laboratory

has

been

certified

as

ISO17025

requirement

by

SGS-CSTC

Standards

Technical

Services

Co.,Ltd.

from

Dec-08,08

to

April-29,09,training

program

of

total

11

days

divided

to

11

sections

including

US

/

EU

Standard

Methods

training,Laboratory

staff

technical

training,ISO-17025

system

set

up

and

SOP

documents

written

up,the

meeting

record

referring

to

CDLL/A-13-02

of

程序文件.

B.

Internal

Audit

The

internal-audit

had

been

conducted

by

the

CDLL

laboratory

Manager

on

April-30,2009,the

report

has

been

summarized

the

control

and

set

straight

of

Chemical

Lab

and

Microbiological

Lab

running

system

per

ISO-17025

criteria.

All

the

correction

actions

is

taking

place

and

will

be

closed

the

end

of

May,09’.

The

audit

focus

on

the

following:

1.

Corrective

action

on

technical

deficiency

from

staff

were

not

trained

and

set

back

full

skill

on

test

methods

compliance

with

ISO-17025

to

fulfill

the

applied

EU

/

US

testing

requirement

from

CNAS-AL-01-02

shown.

2.

Complete

the

程序文件CDLL/A-(00-29)records

for

Chemical

and

Microbiological

laboratory

and

make

sure

to

continue

assess

from

time

being

when

necessary

to

keep

record.

The

internal

audit内审

was

cooperated

with

SGS

auditor,Henter

Huang,throughout

the

above

11

sections

set

time

and

the

corrective

actions

had

been

done

in

time

and

accept

by

auditors.

The

internal

audit内审

report

is

referring

to

CDLL/A-11-03

of

程序文件CDLL/A-(00-29).

C.

Proficiency

Test

能力认可and

internal

Correlation

programs

Proficiency

Test

(PT):

The

lab

had

finished

all

the

2

rounds

PT

tests

in

2009,including

2

major

category

EN71

and

RoHS

requirement

that

were

organized

by

CNAS

authorized

____________

organizations.

The

PT

was

highlighted

and

taken

corrective

action

by

P-lab.

The

action

report

No.

is



____________

with

report

received

on

_________

and

the

results

were

match

and

pass

with

their

set

data

from

their

given

samples.

External-lab

correlation

testing

(IQC):

The

lab

had

taken

part

in

a

lot

of

correlation

tests

including

RoHS

and

6

Phthalates

during

2008-09’.

The

results

are

satisfied

(see

the

following

summary):

No.

Name

of

RRT

Initiator

End

Lab

list

description

1

CDec

06

RSTS

Jan.

2007

SZ,GZ,SH,…

total

heavy

metal

content

of

fabric

sample

2

Cadmium-001

Guangzhou

Lab

Jan.

2007

GZ,SZ

Cadmium

content

in

Rubber

material.

3

CANON

Japan

lab

Jan.

2007

SZ,GZ,HK,…

Pb/Ni+P

in

plating

on

Ni/SPCC

sample

4

Inter-lab

correlation

exercise

Jan

2007

-

Softline

RSTS

HK

Mar,2007

Phthalates

&

Azo

dyes

test

in

standard

solution

and

samples

5

SGS-BFR-PAT-011

RSTS

TW

Apr.,2007

PBBs&PBDEs

in

standard

solution

and

samples

6

SGS-HM-PAT-012

(RoHS)

/

SGS-ELV-PAT-001

(ELV)

RSTS

E&E

May,,2007

Heavy

metal

testing

7

Nintendo

Round

Robin

Test

Japan

lab

Jun.

2007

phthalates

content

in

pellet

&

powder

by

Nintendo

method

8

EE/HL/SL

0708

RSTS

Aug,2007

phthalates

9

RRTP-0701

Nov.2007

Heavy

metals

(Pb,Cd,Hg,Cr)

PBBs

&

PBDEs

RoHS

6

items

10

Physical

&

Mechanical,Flammability

Test

SH-HG

Nov

2007

HG,HK

ASTM

F963-07,Canada

Crc.931BS7272-1,2

Internal

Comparison

Test

from

Technicians

Comparison

tests

were

completed

and

continue

monthly

according

to

the

record

on

______

throughout

year

2009

May.

The

reference

standard

_________

were

used

as

a

correlation

subject

to

be

tested

by

3

technicians

in

laboratory.

D.

Complaints

&

feedback

from

customers:

In

_____

2009,there

was

one

complaint

received

from

the

client

xxxx.

The

case

was

on

that

the

laboratory

report,which

cannot

meet

with

the

client’s

requirement

and

the

record

is

filed

on

CDLL/A-06-01.Our

laboratory

executive

has

taken

relevant

immediate

corrective

actions

and

the

client

end

up

accepted

correction.

To

meet

with

our

inner

management

requirement,corrective

action

was

verified

further

through

customer

satisfactory

survey

which

referring

to

the

record

on

CDLL/A-06-02客户抱怨登记表and

CDLL/A-23-01报告更改/补发申请

E.

Corrective

and

preventive

actions

initiated

The

lab

can

taken

corrective

action

for

SGS

raised

external

&

internal

audit,client’s

complaint

/

claim

and

unsatisfied

results

coming

from

comparison

test

in

time.

The

individual

程序文件

regarding

to

preventive

actions

had

been

issued,and

the

preventive

action

plan

need

to

be

made

in

next

lab

meeting

by

31st,May

2009.

F.

Inner

Quality

monitor

results

All

the

lab

quality

monitors

have

been

assigned

and

trained.

The

physical-lab

and

electrical-lab

have

issued

the

Inner

Quality

monitoring

schedule

and

the

relevant

monitoring

have

been

implemented

according

to

the

LQP021

in

Jan

2008.

But

the

chemical

lab

and

C/S

haven’t

made

the

Inner

Quality

monitoring

schedule,need

to

be

followed

up

by

early,2008.

2.

Review

current

lab

capacities

and

resources

for

future

development/

New

technology

or

equipment

The

lab

shall

applied

for

CMA

accreditation

for

company

future

business

development

requirement.

The

lab

technical

colleagues’

title

of

relative

professional

engineer

(English,computer

exam,paper

writing)

should

be

followed

up.

3.

Others:

H.

Training

The

quality

system

training

shall

be

specified

and

strengthened

with

individual

quality

procedure

implement

to

lab

staff.

The

documents

written

method

and

the

complaint

/claim

case

etc.

shall

be

trained

in

toys

requirement.

For

the

staff

turnover

rate

is

high,the

new

staff

should

be

trained

in

technical

in

time.

By

2010

year,the

laboratory

will

increase

headcount

to

10

persons

in

total.

Training

program

will

be

arranged

the

end

of

2009

for

the

new

staff

and

continuing

education

to

old

staffs.

From

time

to

time

seminar

hold

by

the

third

party

that

our

staff

are

arranged

to

join

for

nourishing

their

technical

knowledge.

I.

Household

and

safety:

The

safety

training

course

for

all

lab

staffs

was

conducted

by

QA

coordinator

in

Feb

2007.

The

lab

safety

audit

works

were

conducted

by

SGS

global

QA

manager

in

June

and

by

Shenzhen

QA

in

Sep

2007

respectively.

The

Shenzhen

HR

and

QA

jointly

checked

the

lab

safety

works

in

Nov

2007.

4.

Output

/

Improvement.

Followed

up:

Items

Action

description

Followed

by

Completed

date

Remark

Corrective

action

for

HOKLAS

The

customer

satisfaction

survey

implemented

according

to

LQP024

including

response

of

phone

etc.

At

early

of

March

2008

Overall

objectives

&KPI

Some

KPIs

and

objectives

need

to

be

redefined

in

2008.

At

the

end

of

Mar

2008

Preventive

action

Preventive

action

plan

items

raised

At

the

end

of

Mar

2008

Training

Document

write

e.g.

SOP,WI

and

Claim/complaint

case

training

courses

shall

be

held.

July

2008

Quality

monitor

The

C-lab

and

C/S

department

inner

Quality

monitor

schedule

shall

be

made

At

the

early

of

Mar

2008

CMA

accreditation

lab

technical

colleagues’

title

of

relative

professional

engineer

(English,computer

exam,paper

writing)

should

be

followed

up

By

Aug

2008

Standard

purchase

The

support

for

standard

purchase

shall

be

strengthened,the

stand-in

shall

be

assigned.

t

By

March

2008

Prepared

by:

Reviewed

by:

Annex:

Summary

of

action

required

internal

audit

by

Shenzhen

QA

in

2007

Subject

Non-compliance

CAR-NO.

Personnel

SZ0709-A01

Equipment

SZ0709-A02

Report

results

control

SZ0709-A03

Personnel

SZ0709-A04

Sample

handling

SZ0709-A05

Method

confirmation

SZ0709-A06

Method

confirmation

SZ0709-A07

Safety

I

SZ0709-A08

Traceability

SZ0709-A09

5

of

6

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