Table 1 Screening of high-risk links in failure modes of packaging defects.

From: Application of healthcare failure mode and effect analysis in controlling surgical instrument packaging defects

Process steps

Possible failure mode

Severity

Failure incidence

Risk priority number

If the decision (take action or stop) index was greater than 8, the action would be stopped, and the reason should be indicated

A Unloading

A1 Download

A1a Unloading error

1

4

4

Stop

A1b Drop

1

2

2

Stop

A1c Omission

1

1

1

Stop

B Inspection

B1 Function check

B1a Not checked

4

4

16

Continue

B1b Missed

2

·2

4

Stop

B1c Misjudgment

1

1

2

Stop

B1d Wrong inspection method

2

3

6

Stop

B2 Cleaning quality check

B2a Not checked

1

4

4

Stop

B2b Missed

1

4

4

Stop

B2c Misjudgment

1

1

1

Stop

B2d Did not see clearly

2

3

6

Stop

B2e Wrong inspection method

2

2

4

Stop

B3 Quantity check

B3a More

4

4

16

Stop (verification and packaging would be eliminated in the future)

B3b Less

4

4

16

Stop (verification and packaging would be eliminated in the future)

B4 Model check

B4a Model missing

2

2

4

Stop

B4b Species missing

4

1

4

Stop

B4c Incorrect model identification

1

1

1

Stop

B5 Chemical indicator check

B5a Not put in

4

4

16

Stop (verification and packaging would be eliminated in the future)

B5b Put too much

4

1

4

Stop

B5c Indicator selection error

2

1

2

Stop

D Packaging

D1 Packaging material check

D1a Type selection error

1

1

1

Stop

D1b Specification or model error

1

2

2

Stop

D1c Packaging material quality defects

2

2

4

Stop

D2 Packaging method check

D2a Wrong

2

1

2

Stop

D3 Sealing

D3a Loose packaging

3

4

12

Continue

D3b Indicating tape did not meet the criteria

1

1

1

Stop

D4 Labeling

D4a The label was printed incorrectly

4

4

16

Stop (verification and packaging would be eliminated in the future)

D4b Label pasting error

4

1

4

Stop

D4c Incorrect new label

2

1

2

Stop

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