8D Report

• Document number

• Issued Date

  Date

• Signature of the issuer

  Sign

D0 - CA Information

• Issuer

• Issuer Email

• Supplier

• Addressee of the 8D

• Addressee Email

• Location of the Supplier

• Part Number

• Part Description

• Supplier Part Number

• Serial Number

• Order Number

• Delivery Number

• What action was taken when the discontinuity was discovered?

  Select Rejected Reworked by Handicare Concession

  • Rejected
  • Reworked by Handicare
  • Concession

• Concession number

D1 - Team

Team created to solve the problem

Leader

• Name

• Departement

Member

• Name

• Departement

D2 - Issue / Concern

Description of the problem

• What is the problem?

• Why is it a problem?

• When was the problem discovered?

  Date

• By whom was the problem discovered?

• Is it a recurrent problem?

  Yes

  No

• Comments

• Which products are affected?

D3 - Containment Actions

Containment actions

• What were the containment actions (within 24h)?

• Select date

  Date

Isolation of potential faulty products

• At customers?

  Yes

  No

• Comments

• Quantity

• Work in progress?

  Yes

  No

• Comments

• Quantity

• In shipping?

  Yes

  No

• Comments

• Quantity

• Items in stock?

  Yes

  No

• Comments

• Quantity

• At suppliers?

  Yes

  No

• Comments

• Quantity

• Potential faulty products in transit?

  Yes

  No

• Delivery number

• Quantity

Delivery of fault-free products

• Indicate date of shipment

  Date

• Indicate the quantity shipped

• Delivery number

• Product serial number

• Markings on delivered OK parts?

  Yes

  No

• Description of the marking

Other possible impacts of the problem

• Indicate if the problem could have impact on the safety

  Yes

  No

• Details

• Indicate if the problem could have impact on the environment

  Yes

  No

• Details

D4 - Root Cause

Root cause(s) of the occurence

• Cause(s)

  Select People Material Methods Equipment Measurement Environment

  • People
  • Material
  • Methods
  • Equipment
  • Measurement
  • Environment

• Details

• Date

  Date

Root cause(s) of non detection

• Cause(s)

  Select People Material Methods Equipment Measurement Environment

  • People
  • Material
  • Methods
  • Equipment
  • Measurement
  • Environment

• Details

• Date

  Date

D5 - Corrective Action(s) Retained

Corrected Action(s) Retained

• Which corrective action(s) is (are) retained?

  Engineering change

  Process change

• Corrective action(s) retained.

  Select Engineering change Process change

  • Engineering change
  • Process change

• What is the planned implementation date?

  Date

• By whom?

• Serial number?

• Batch number?

D6 - Corrective Actions Implementation

Implementation of the Corrective Action and Controls

• Indicate which controls (with records) have been put into place to verify the efficiency of the corrective action

• Date

  Date

D7 - Preventive Actions

Preventive Action(s) to Prevent Recurrence of the Problem

• Describe specific preventive actions

• Date

  Date

• Implementation date

  Date

• Batch number

• Serial number

• Delivery number

• Can this problem occur on other products or processes?

  Yes

  No

• What?

• Who is taking care?

• When?

  Date

• Review existing FMEA's?

  Yes

  No

• Comments

• Implementation date

  Date

• Review existing engineering documents?

  Yes

  No

• Comments

• Implementation date

  Date

• Review work instructions and control plan?

  Yes

  No

• Comments

• Implementation date

  Date

• Review existing procedures?

  Yes

  No

• Comments

• Implementation date

  Date

• New documents customer approval?

  Yes

  No

• Comments

• Implementation date

  Date

D8 - Handicare Validation

Validation of the Answer & Implementation and Effectiveness Verification

• Is the initial validation of the root cause research and of the corrective/preventive actions (D3 -> D7) approved by the issuer?

  Yes

  No

• Comments

• Name

• Date

  Date

• Who verified the implementation?

• Comments

• Date

  Date

• Who performed the efficiency check?

• Comments

• Date

  Date

• Who closed the 8D report?

• Comments

• Date

  Date

• General comments (or other documents to close)

The document has been completed and should be returned within 10 days to the issuer identified in D0