Current requirement

Right material with right quantity

原材料(塑料粒子)来料检查
Raw material incoming inspection
Right material certificate

Right parts with right quantity

Supplier report(for domestic supplier)

采购部件的来料检查
Raw material incoming inspection

Incoming inspection

Material(Resin) kept in proper condition

Storage
Purchased parts kept in proper condition
储存

Quality status identification

FIFO
Take material from warehouse
领料
Material or part in line with material requisition form

Right drying time

Right drying temperature

Drying material
MDL

Right humidity content

Mould
 Mould

Injection
注塑

Injection machine

Process parameter

Appearance

Inspection
First part
检验

Process inspection

Packaging
包装

Storage
储存
 Current requirement Control method

Right material with right quantity Visual

Right material certificate Visual

Right parts with right quantity Visual

Supplier report(for domestic supplier) Visual

Incoming inspection Visual & inspection equipment

Material(Resin) kept in proper condition Visual

Purchased parts kept in proper condition Visual

Quality status identification Visual

FIFO Visual

Material or part in line with material requisition form Visual

Right drying time MDL

Right drying temperature

MDL
MDL

Right humidity content Moisture meter

Mould after maintenance Visual

 Mould after maintenance Visual

Right cooling system per water pipe instruction Visual

Right date wheel VIsual

Proper injection machine as defined in control plan Visual

Robot in proper condition Visual

Right Process parameter & Ok Start for each reference Visual

Free from obvious flow mark, damage, burs, burn, lack of

Visual
material and obvious black point in function area

Appearance, dimension and function in line with specification Gauge & inspection equipment

Appearance, dimension and function in line with specification Gauge & inspection equipment

Right quantity Visual

Box free from damage Visual

FIFO Visual
 Alternate control Method

Risk
Related risks
Consequence Likelihood Risk Rating
Quantity not right 1 2 2

No material certificate 2 5 10

Quantity not right 2 2 4

No supplier report 5 2 10

Incoming inspection equipment failure 3 3 9

Nonconformity found while production

urgently requires the parts 5 3 15

Material damaged 2 2 4

Parts become rusty 5 3 15

No identification 3 2 6

FIFO not followed 3 2 6

Material requisition form not right 3 2 6

Drying time too short or too long 3 2 6

Drying temperature out of Spec 3 2 6

MDL failure 3 3 9

Not able to test humidity content due to

malfunction of the moisture meter 5 3 15

Mould not maintained 5 1 5

No identification 2 2 4
Mould failure 5 3 15

Cooling system not well connected 5 1 5

Date wheel not right 3 3 9

Machine failure 5 3 15

Machine doesn't give alarm when process

parameter is not right 5 1 5

Robot position not right 5 3 15

Can't product good parts with the existing

parameter 5 3 15

Bur on the part 5 3 15

Gauge & inspection equipment failure 5 3 15

Gauge & inspection equipment failure 5 3 15

Quantity not right 3 2 6

Box damage 3 2 6

FIFO not followed 3 2 6

 Alternate method

N/A

Without material certificate, special approval from quality & operations

manager is required in case of urgent need, finished products must be
put on hold until material certificate is received.

N/A

Without material certificate, special approval from quality & operations

manager is required in case of urgent need, finished products must be
put on hold until material certificate is received.

In case of incoming inspection equipment failure, use backup equipment,

if backup equipment is not available, inspection can either performed at
third party lab or by the supplier

100% sorting

N/A

100% sorting

N/A

N/A

N/A

N/A

N/A

Backup MDL

1. Appearance check after injection

2. 100% inspection after injection

N/A

N/A
Block one or several cavities to produce

N/A

N/A

(1) Change machine

N/A

1. Not to use robot for production

2. 100% appearance inspection

1. Change process parameter

2. 100% inspection

Remove the bur

(1) Use backup gauge & inspection equipment

(2) Measure the part in third party lab

(1) Use backup gauge & inspection equipment

(2) Measure the part in third party lab

N/A

N/A

N/A
 Approval Related document

Quality & Operations manager Special work instructions

Quality & Operations manager

Quality & Operations manager Special work instructions

Special work instructions

Quality & Operations manager Contingency plan

Quality & Operations manager Special work instructions

Quality & Operations manager Special work instructions

Contingency plan

Quality & Operations manager Special work instructions

Quality & Operations manager Special work instructions

Quality & Operations manager, by 1. Special work instructions

customer if necessary 2. Change procedure

1. Special work instructions

Quality & Operations manager
2. Contingency plan

1. Special work instructions

Quality & Operations manager
2. Interim Ok-Start

1. Special work instructions

Quality & Operations manager

1. Special work instructions

Customer

Customer 1. Special work instructions

 QWI-QD-001
V01

Monitoring

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & produciton report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12
1. Daily meeting & production report
2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12

1. Daily meeting & production report

2. Process control & audit
3. GP12
1. Daily meeting & production report
2. Process control & audit
3. GP12
1. Daily meeting & production report
2. Process control & audit
3. GP12
1. Daily meeting & production report
2. Process control & audit
3. GP12
1. Daily meeting & production report
2. Process control & audit
3. GP12
 RISK MANAGEMEN

RISK LEVEL DETERMINATION

Risk Occurrence Probability (ROP)

Risk Severity Inevitable Highly

Likely Probable Possible
10 5 3 2
Complete Interruption
10 100 50 30 20
完全中断

Severe Interruption
5 50 25 15 10

Major Interruption 3 30 15 9 6

Moderate Interruption 2 20 10 6 4

Minor Interruption 1 10 5 3 2

Could Could Could Could

happen at happen 2- happen happen
any moment 3 times once per once every 4
per year year -5 years
Severe Interruption

风险等级 风险可接受度
建议采取的行动Recommende
Risk Level Risk Acceptability

低风险 •不需要额外的风险控制措施。
Low Risk No additional risk control measures may be needed.
•确保现有的控制措施得到遵守和维护。
Acceptable Ensure existing control measures are being followed and maintaine
可接受的 •要频繁地检查和监测质量管理体系风险，以确保分配的质量管理体
Frequent review and monitoring of the srisk are required to ensure
increase over time.
中度风险Medium •在长期改善措施和业务连续性计划建立的过程中，可以采取临时风
可容忍的 Interim risk control measures, such as Operation control, Administ
Risk Tolerable
term improvement
• There measures,
should not be business
any interim continuity
risk control plan areRbeing esta
measures.
correction, containment action, administration activities control or t
不可接受的
高风险
Not acceptable 施。风险控制措施不应过分依赖于纠正，行动，行政活动控制或临
• If practicable, the QMS risk should be eliminated before work com
予以消除。
MANAGEMENT - RISK MATRIX

bility (ROP)

Unlikely
1
完全中断（停止履行业务目标）,交货无限期延期，肯定会造成客户投诉.
5- Complete Interruption(Fulfilling the business objective cease) Certain to cause customer complaint & Delivery is delayed
10 indefinitely, certain to cause customer complaint

严重中断（可持续实现业务目标但极度困难,肯定会导致客户投诉或出现交货问题）
5 4- Severe Interruption(Fulfilling the business objective continues but with extreme difficulty.Delivery is delayed more than one
week， high likely of customer complaint

重大中断（继续实现业务目标但存在一些困难,有可能会导致客户投诉或出现交货问题） Major Interruption(Fulfilling the

3 business objective continues but with some difficulty
Customer notification is required for acceptance or extension,may cause customer complaint

一般中断 (一般的中断（继续实现业务目标，问题是可管理的,质量和交货风险非常低）
2 Moderate Interruption(Fulfilling the business objective continues and problem is manageable，Product Quality & Delivery is
impacted slightly

轻微中断(继续业务目标履行，问题很容易处理,没有质量或交货风险)
Minor Interruption (Fulfilling the business objective continues and problem is easily handled. No affect on Quality or Delivery of
1 Product.

Not
expected to
happen

建议采取的行动Recommended Actions

be needed.

ng followed and maintained.

，以确保分配的质量管理体系风险级别准确，并且不会随时间而增加。
sk are required to ensure that the risk level assigned is accurate and does not
的过程中，可以采取临时风险控制措施，如操作控制、行政控制等。
eration control, Administrative controls, may be implemented while longer
tinuity
trol plan areR上isk
measures. being established. •
control measures should not be overly dependent on
ation activities control or temporary appliances. •不应有任何临时风险控制措
行动，行政活动控制或临时用具。
iminated before work commences. 如果切实可行，QMS风险在工作开始前应
elivery is delayed

ayed more than one

ruption(Fulfilling the

uality & Delivery is

Quality or Delivery of