IC IMPROVEMENT FORM

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IC IMPROVEMENT FORM

Form to be completed

Tick relevant box *

Product

Material / Supplied item

Batch / Date of manufacture/ assembly / packaging

Employee name &/ or #

Procedure

Process

Supplier

Other:

Required

Division

A - LOGISTICS

B - ADMINISTRATION

C- SALES

D- ACCOUNTS

Other:

Clear selection

Provide details for the above e.g. Product name, Material details, BATCH / LOT, Expiry, Employee name / # etc

Origin *

C - Customer Complaint

A - audit finding

S - QC non compliance observation to an SOP

M - Non compliant Material

NCP - Non compliant product

H - Health & Safety Incident

U - Unsafe device incident

I - Product improvement

R - Process Improvement

O - Other Improvement e.g. from management Review

Pr - Principal initiated Recall

Pa -Advisory Notice

Required

Details of Non Conformance *

Date of incident *

YYYY

If a complaint then Initial evaluation

Patient adverse event - additional surgery, injury

Patient affected but not an adverse event

Product failure - maybe user or supplier fault

Not a complaint non conforming product

Detail the justification if not a complaint non conforming product

Root Cause Analysis (use Cause and Effect) Agree on the problem statement (also referred to as the effect). Be as clear and specific as you can about the problem. Beware of defining the problem in terms of a solution Note that the “five-whys” technique is often used in conjunction with the fishbone diagram – keep asking why until you get to the root cause. Agree on the major categories of causes of the problem e.g. equipment or supply factors, environmental factors, rules/policy/procedure factors, and people/staff factors (6M Man, Machine, MotherNature (environMent), Material, Method, Measurement) *

Man

Material/ Product

Method (SOP)

Environment (+infrastructure (MotherNature))

Measurement (QC)

Machine (=equipment)

Details of Root Cause:● Brainstorm all the possible causes of the problem. Ask “Why does this happen?” Continue to ask “Why?” and generate deeper levels of causes and continue organizing them under related causes or categories. Identify and then address root causes to prevent future problems. A full report can be added into the Incident Report (Sheet) - email to the administrator

Actual or Possible Resolution

Possible REWORK

Possible CONCESSION

ACTUAL Return

ACTUAL Disposal

ACTUAL Rejection

Possible RECALL - Notification to MCC

RECALL not required in the event of a Principal RECALL

NOTHING

Correction Required *

Yes

Maybe

Other:

Incident Reportee and Manager to discuss and advise possible Corrective Action (Manager Name) and possible deadline date

Reported by (Name)

Corrective Action deadline date

YYYY

Origin Letter (C A S M NCP H U I P other)

Date Submitted *

YYYY

Submit

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