Corrective Action - Excel

Document Sample
Corrective Action - Excel Powered By Docstoc
					                                     ISO/TS Checklist
Title Corrective and Preventive Action

 No                                         Item                                   Available (√)
       Does Corrective Action raised when there is Supplier Non Conformity,
       Internal Non Conformity, Internal or External Audit,Customer Complaint,
   1   Customer Rejection?
   2   Does Control of Non conformity available before Corrective Action?
   3   Does Root Cause being investigated prior Corrective Action suggested?
   4   Does Corrective Action related to Root Cause?
   5   Does error proofing being applied for Corrective Action?
       Does Corrective Action being applied for all similar process or material or
   6   products?
       Does customer specific method being used for Corrective and Preventive
   7   Action?
       Does Preventive Action being raised when foresee Potential Non
   8   Conformity?
       Does Potential Non Conformity being identified before suggesting Preventive
   9   Action?
       Does potential root cause being identified prior suggesting Preventive
  10   Action?

  11 Does follow up action available for both Corrective and Preventive Action?
     Does cycle time for root cause investigation, suggesting Corrective and
  12 Preventive Action and closing the Corrective and Preventive controlled?
     Does documented Procedure available and indicate clearly of the above
  13 control?


                                                                                  Checked

                                                                                  Date:
                                  ISO/TS Checklist
Title Continual Improvement

 No                                   Item                                    Available (√)
     Does Continual Improvement includes Cost Reduction and Process Variation
   1 (Cpk)?




                                                                             Checked

                                                                             Date:
                                      ISO/TS Checklist
Title Control of Non Conformance

 No                                           Item                                     Available (√)
       Does authorisation being clearly indicated in the documented Procedure for
       control of non conformance that includes rework, scrap, return, accept as it is
   1   and deliver as it is?
       Does evidence available to show control of non conformance of the above
       being authorised by the personnel as indicated in the documented
   2   Procedure?
   3   Does rework instruction available when there is rework required?
   4   Does customer waiver available when request for deliver as it is?
       Does expiry date and quantity clearly indicated when ask for customer waiver
   5   as above?
       Does control of non conformance includes potential non conformance found
   6   during transit or delivery or transportation?




                                                                                     Checked

                                                                                     Date:
                                     ISO/TS Checklist
Title Internal Audit

 No                                          Item                                   Available (√)
       Does all Internal Auditors being trained? Training Record available and
   1   Competency being verified prior performing audit?
   2   Does Internal Auditor Competency Requirement being clearly defined?
       Does Internal Audit Planning being developed, then review and might be
   3   revised every time after performing internal audit?
       Does Internal Audit Planning being planned based on the importance of the
   4   processes or areas of audit?
       Does Internal Audit Planning being review and might be revised when there
   5   is increased of customer or internal rejection?
   6   Does Internal Audit Schedule based on Process Approach?
       Does night shift being included in the Audit Schedule ( COP-Part
       Manufacturing and Manufacturing Process Audit shall be performed for night
   7   shift production)
       Does night shift audit includes observing the the handover from morning to
   8   night shift?
       Does all COP, SP and MP being included in the both Internal Audit Planning
   9   and Schedule?
       Does Internal Audit and Management Review being audit before 1st Stage
  10   Audit or Adequacy Audit?
  11   Does Internal Audit include Manufacturing and Product Audit?
       Does Production Control Plan being used during Manufacturing Process
  12   Audit?

  13 Does Product Audit includes Packaging, Labelling, Critical Characteristic?
     Does Samples for Product Audit taken from different production stages
  14 which depends the severity of the characteristic as per PFMEA?
  15 Does Corrective Action raised when there is non conformity?
  16 Does Corrective Action closed prior 2nd Stage or Compliance Audit?
     Does documented Procedure available that indicate clearly of the above
  17 control?


                                                                                    Checked

                                                                                    Date:
                                       ISO/TS Checklist
Title Control of Monitoring and Measurement Devices

 No                                          Item                                       Available (√)
       Does all deives being identified with label and due date for calibration being
   1   clearly indicated?
   2   Does Masterlist of Devices available?
       Does Permission Error being identified for each type of the devices and
       compared with the Measurement Uncertainty as shown in the Calibration
   3   Report?
   4   Does Calibration Cert. being signed after verification?

   5 Does Lab appointed for Calibration and testing is ISO/IEC 17025 accredited?
     Does Lab Scope of the Accreditation tally with calibration and testing
   6 services provided?
     Does internal Lab Scope available that consists of all type of inhouse
   7 inspection, testing and calibration activities?
     Does Work Instruction and SOP developed for all type of inhouse inspection,
   8 testing and calibration activities?




                                                                                        Checked

                                                                                        Date:
                                   ISO/TS Checklist
Title Preservation

 No                                      Item                                     Available (√)
   1 Does FIFO practised for material and finished goods?
   2 Does regular stock check available?
     Does material and finished goods being identified with appropriate part
   3 name, part number, Lot or Batch No. and date for FIFO purposes?
     Does expired or damaged material or goods being identified to prevent from
   4 unintended used?




                                                                                  Checked

                                                                                  Date:
                                    ISO/TS Checklist
Title Tooling

 No                                      Item                                      Available (√)

   1 Does all mould, tools and jigs being permanent marked with identification?
   2 Does any special mark available for Customer own property or tooling?
     Does the inventory of the critical spare parts being controlled and minimum
   3 stock being controlled?




                                                                                   Checked

                                                                                   Date:
                                    ISO/TS Checklist
Title Production, Inspection and Testing

 No                                         Item                                 Available (√)
   1 Work Instruction or SOP make available at work station?
     Does Production Schedule available and order driven ( no PO or forecast, no
   2 production)
   3 Work Instruction or SOP includes mould set up?
   4 1st piece buy off or 1st Set up verification available?
   5 1st and last piece comparison available?
   6 The above tally with Production Control Plan?
     Does Inprocess Inspection and Testing being performed as per Production
   7 Control Plan?

   8 Does inspection and testing criteria for attribute data sampling is ZERO?
   9 Does all shift equiped with QC responsible personnel?
     Does Inspection and Testing Status available after that activities being
  10 carried out?
     Production Operators available of Customer assigned Special
  11 Characteristic?
  12 Rejection Bin available?
  13 Identification tag or label available?
     Traceability information available so that material, operators and machine
  14 involved can been known whenever necessary?


                                                                                  Checked

                                                                                  Date:
                                   ISO/TS Checklist
Title Process Design and Development

 No                                     Item                                      Available (√)

   1 APQP Members List or Organisational Chart available?
   2 Does Team Feasibility Commitment available during Kick Off Meeting?
     Any evidence show APQP Members being briefed of the Customer Specific
   3 Requirement?
   4 Master Schedule available for new Design and Development Project?
     Master Schedule consists of 3 important phases; Prototype, Prelaunch and
   5 Production?
   6 The Sequence of the activities appear in the Master Schedule logical?
   7 Prototype Control Plan available?
   8 Inspection Record as per Prototype Control Plan available?
   9 Customer approval available prior proceeding to Pre-Launch Phase?
  10 Process Flow available?
     Production Layout available? Does distance between the process and
  11 travelling time being considered?
  12 PFMEA available?
  13 Content of PFMEA covers all existing and potential failure?
     Does all Customer assigned Characteristic being included in the PFMEA
  14 upon severity above 8?
  15 Prelaunch Control Plan available?
     Does all product failure being inspected and indicated in the Product
  16 Characteristic Column in the Prelaunch Control Plan?
     Does all causes of the failure being control and indicated in the Process
  17 Characteristic Column in the Prelaunch Control Plan?
     Does all Customer assigned Characteristic being included in the Prelaunch
  18 Control Plan?
  19 Does all inspection record available as per Prelaunch Control Plan?
  20 Does customer approval available prior Production Stage?
  21 Does Production Control Plan available?
     Does all Customer assigned Characteristic being included in the Production
  22 Control Plan?

  23 Does GR&R performed for both variable and attribute measurement system?
  24 Does variable GR&R achieved less than 10% and ndc 5?
  25 Does all inspection record as per Production Control Plan available?
     Does Production Control Plan includes all type of testing as per customer
  26 requirement?
     Does Work Instruction or SOP being developed as per Production Control
  27 Plan?
     Does all other related document such as Work Instruction, SOP and
     inspection indicated with Special Characteristic Symbol as per Production
  28 Control Plan?
     Does data collected during Trial Run and Ppk being calculated as
  29 appropriately?
     Does Layout Inspection and performance testing being carried out as per
  30 customer specific requirement?
31 Does APQP Sign Off available prior PPAP activities?
32 Does PPAP approved by Customer prior Production?
33 Does PPAP applied to Supplier as well?
   Does any changes to Product Design or Process Design being reviewed of
34 its impact ( review the existing PFMEA )?




                                                                            Checked

                                                                            Date:
                                     ISO/TS Checklist
Title Purchasing

 No                                       Item                                     Available (√)

   1 Does Approved Supplier List Available?
   2 Any evidence show Purchase from Customer Approved Sources?
   3 Does Selection Criteria available?
     Does Selection Criteria considered to pricing and quality of material
   4 supplied?
   5 Does Evaluatiin and Re-evaluation Criteria available?
   6 Does Evaluation being carried out after new supplier selection?
   7 Does Re-evaluation being carried out at least once per year?

     Does Supplier Performance being monitored that includes Quality, Delivery,
   8 Premium Freight, Down Time and Customer Notification on Special Status?
     Any evidence show Supplier comply to any Legal or related Regulatory ( e.g.
   9 Hazardous Substances Free )?
     Any evidence show promoting Supplier to monitor the production
  10 performance?
  11 Does all supplier ISO9001: Certified or 2nd party audit being performed?
     Does Supplier Development Program being developed? Any evidence show
     asking supplier to source own consultant for ISO/TS or Training Program
  12 available for Supplier to move forward towards ISO/TS.
  13 Any evidence show all purchased material being verified during receiving?
  14
  15
  16
  17

                                                                                   Checked

                                                                                   Date:
                                    ISO/TS Checklist
Title Customer Related Process

 No                                      Item                                       Available (√)

     Does Customer Specific Requirement being identified and forwarded to
   1 Document Controller for document controlled?
   2 Does all Process Head being briefed of the CSR?
     Does feasibility study being carried out before quotation which includes
     Recycling Requirement, Environmental Requirement, Safety and Health
   3 Requirement, Capacity, its Environmental Impact and Business Risk?
   4 Does Customer Survey being carried out? Analysis available?
     Does Customer satisfaction being monitored which includes Quality,
     Delivery, Premium Freight, Down Time and Customer Notification on Special
   5 Status?
     Do customer require certain software subscription such as 3D, Catia? If yes,
   6 any evidence show company has subscribed to the above software?
   7
   8
   9
  10
  11

                                                                                    Checked

                                                                                    Date:
                                  ISO/TS Checklist
Title Infrastructure and Maintenance

 No                                    Item                                     Available (√)

     Does Production Layout being reviewed from time to time for its
   1 effectiveness and efficiency ( waste minimisation )?
     Does Predictive and Preventive Maintenance Program available for each of
   2 the machinery, jigs and mould (upon applicable)?
     Does all measurement Jigs being verified from time to time? Schedule
   3 established?
     Does lighting bright enough for area which inspection or tesging being
   4 carried out?
     Does reasonable house keeping and cleaniless available especially at
   5 Production Area.
   6
   7
   8
   9
  10
  11

                                                                                Checked

                                                                                Date:
                                    ISO/TS Checklist
Title HR Training

 No                                      Item                                       Available (√)

     Does Competency Requirement being defined for each of the Position (
   1 Education, Experience, Skill and Training) as per Organisational Chart?
   2 Does Training Needs Analysis available for each personnel?
   3 Does Training Plan established based on the Training Needs Analysis?
   4 Does Training Plan being fulfilled with Training Record?
     Does Training Record includes ISO/TS Awareness Training, APQP, FMEA,
   5 SPC, MSA and PPAP ( upon applicable )?
     Does Training Effectiveness Evaluation conducted for all training especially
   6 for the Training as above?

   7 Does On job Training Record available especially for Production Operators?
     Does Skill Chart available especially for Production Processes which
   8 considered as skillful task that required for backup?

     Does Employee Survey being carried out? Analysis available which give idea
   9 on how to motivate all personnel in participating improvement program?
     Does Improment Program available which related to Quality and
  10 Productivities that suggested by all levels of employees.
     Does any activities being carried out to check whether all levels employees
     understand Quality Policy, Objectives, importance of not compliance to the
  11 specific guidelines or instruction?
     Does documented Procedure available that indicate clearly of the above
  12 Requirement?
                                                                                    Checked

                                                                                    Date:
                                    ISO/TS Checklist
Title Management Commitment

No                                        Item                                        Available (√)

     Does Management Review conducted before the Adequacy Audit or 1st
   1 Stage Audit?
     Does Management Review include all Review Input as followings: Result of
     Internal and External Audit, Process Performance ( KPI Performance),
     Summary of Design and Development (Current stage, potential risk,
     progress, expenditure ), Potential and actual field return and its impact on
     QUality, Safety, Environmental, Changes that could affect the QMS,
     Recommendation for Improvement, Customer Feedback ( Customer Survey
     result and Customer Complaint ), Status of Corrective and Preventive Action,
     Follow up Action from the previous Management Review and Cost of Poor
   2 Quality, Sanction Interpretation?
     Does Management Review indicate the decision on Process, System and
   3 Product Improvement? As well as its resources needed?
     Does Management Representative and Customer Representative
   4 appointed? Good to have appointment letter?
   5 Does CR knows his / her roles?
     Does Organisational Chart available, updated and indicated with revision
   6 number or date?
   7 Does Organisational Chart being approved by Top Management?

   8 Does Responsibility and Authority being defined for each of the Position?
     Does Quality Policy being translated into different language and all personnel
   9 aware and understand?
  10 Does Business Plan available and includes Quality Policy and all the KPI?
  11 Does Business Plan review from time to time?

                                                                                      Checked

                                                                                      Date:
                                        ISO/TS Checklist
Title Record Control

 No                                          Item                                           Available (√)

       Does Record Masterlist or Record Matrix or Procedure available that indicate
       clearly type of Quality Record to be controlled, its retention period, retrieval (
       can be authorised personnel for access to the record), location, disposition
   1   method, protection control?
       Does the above includes external record such as Supplier DO, Customer
       PO, Calibration Report and other internal record such as Meeting Minutes
   2   and so on.
       Does retention period follow customer specific requirement or comply to any
   3   legal requirement?
   4   Does documented Procedure available indicate the control as above?




                                                                                            Checked

                                                                                            Date:
                                    ISO/TS Checklist
Title Document Control

 No                                      Item                                     Available (√)

       Does all Guidelines, Procedure, Work Instruction, Testing Standard,
       Drawing, SOP, Forms, Label, Stickers, Stamp displayed or non displayed
   1   being controlled copy?
   2   Does all indicated with Revision number or date?
   3   Does Master Copy kept for all of the above?
   4   Does Document Change raised when there is any revision?
   5   Does Obsolete copy being controlled? Obsolete Stamp being used?
       Does all external document received being reviewed with 14 working days?
       Any evidence ? ( e.g. Review Stamp with Date, meeting minutes, action
   6   taken record )
     Does ISO/TS Standard, ISO19011, APQP, FMEA, SPC, MSA and PPAP (
   7 Optional ) copy available? Some Certification Body accept photocopy)
     Does Document Control Procedure available which indicate clearly of the
   8 above requirement?
     Any evidence show internal and external suppliers or tool maker remain
   9 private and confidential of all information received?



                                                                                  Checked

                                                                                  Date:
                                      ISO/TS Checklist
Title Customer Oriented Process, Supporting Process and Management Process

 No                                         Item                                         Available (√)

   1   Turtle Diagram available?
   2   Process Owner identified for each COP and SP?
   3   Process Owner know the concept of COP and SP?
   4   Process Owner knows what is Output and Input for each of the Process?
   5   Does Key Performance Indicator being identified for each COP, SP and MP?
   6   Does Risk being analysed for each of the Process?
       Does Contingency Plan identified for each of the critical Risk ( e.g. Labor
   7   shortage, material shortage, utilities interruption )?
       Does Past 12 months performance being compiled, analysis being done and
       further action being suggested upon necessary? (For example, if you plan for
       Apl 07 for Adequacy Audit, then you should get ready Apl 06 to Mar 07
       Performance Data. But to remember that, monthly analysis is expected after
       your ISO/TS Effective Data. Mean, If your Effective Date is on 1/1/07, then you
       should have one copy of analysis from the month of Apl 06 to Jan 07, one
       copy analysis from the month of Apl 06 to Feb 07 and one copy of analysis
       from the month of Apl 06 to Mar 07, total 3 copy of analysis to be showed to
   8   Auditor during their Adequacy Audit.)
   9   Does all COP, SP and MP being captured into the Process Mapping?
       Does all COP, SP, MP and Process Mapping being indicated with Revision
  10   Number and included in the Quality Manual?


                                                                                         Checked

                                                                                         Date:

				
DOCUMENT INFO