Improvement / Corrections 

 Improvements   and   corrections   are   possible   if   processes

 are   evaluated   by   monitoring   and   measurement   analysis:

 whether   there   is a   need   for   improvements   or   corrections.

       Forms  for  Improvement / Corrections:

State   Priority_____________Date______    

Form  No. _____ Revision No.______ Serial No.____

Pages_____Department___________

Name or Define the Subject ______________________________________

Proposal / Request

Originator / Initiator_______________________

Reported / Prepared  by________________________

Name___________________Signature__________

Department.____________

Intra Departments  /  Inter  Departments.  

 Name   of   Departments _______________________________________

Assigned to ( Responsible   Personnel   who  are  likely   users 

and   their   inputs / comments )

Personnel    Names _______________________________________

Signatures________________________________

Staff   Consultation:       

                Originator / Requester’s    assignment   Instructions 

                to   Responsible       

                                 Personnel________________________

                                 _______________________________

Tick Mark appropriately: 

[ A ]   IMPROVEMENTS

[ B ]   CORRECTIONS

PROCESSES  AND  PROCEDURES 

           THAT NEED  IMPROVEMENT / CORRECTIONS

|______________________________________|

Documents  Revision: 

         Documentation in Quality Manual or CRF  

         that need updating: 

         Processes    Procedures     Work   Instructions   

Product      Specifications

Infrastructure   Plants   &   Equipments  /   Instruments  

Methods   of   Tests  of   Raw   Materials   and   Products 

Benchmarks / Measurable   Process   Objectives

Alternate   arrangement   of   Resources   Processes

Procedures   Management   in   unwanted   circumstances.

CAPA   Corrective   Action      Preventive   Action 

Adverse Events / Source Event    Hazards 

Non  Conformances:  Raw Materials   Products    Services:

   ( Maintain  a  registry   of  Non Conformance 

             Products   and   Processes )

Vendors      Sales & Customer   Feedback 

Complaints   ( Internal   or   External   Parties )

Management   Review   Meetings   Outcomes 

|___________________________________|

INPUTS     Where   Applicable   regarding    [ A ]    [ B ]

1 ]  Subject    Background /  Observations / 

                Descriptions  /  Influential

2 ]  Scope  (  Define   Limits  )

3 ]  Purpose   and  Justification  

4 ]  Problem  Detection   Investigation  / Undesirable  Situation

            Production    Non Conformance

                                                                                                   ( table: above left )

5 ]  Root  Cause  Analysis Identification

6 ]  Appropriate  Solution

7 ]  Remedial  Corrective  Action  /  Rationale  /  Identification  

8 ]  Risks  Involved /  Risk Assessment  Management  /  

                Hazards      Safety Function

9 ]  Remedial Preventive  Recurrence  Measures 

       ( Eliminate Cause to Prevent  Recurrence )

10 ]  Opportunities

11 ]  State any  appropriate   reference   from   Knowledge  Bank 

          for a   Solution  /  Benchmarks

             ( Previous  Events  relevant data to  learn from )

                                                                       Process Assessment

                                                                                    ( table:  above right )

12 ]  Refer   Feed Back   Surveys   in   regard   to   above   Subject.

13 ]  Customer   Feedback / Complaint

            ( table: below right )

14 ]  Any  related   Subject  Matter 

                      to   make   this   matter   complete. 

        State their   conclusion    and   recommendations. 

15 ]  Any  Government   Legislation   Regulations

                                |  SCROLL DOWN |  

16 ]  Any Manufacturers  who have Implemented this Subject / System.

17 ]  Relevant   Supportive   Documents  /  Company   Standard, 

          Technical   &   Research   Papers, etc     

18 ]  Any  Integration  /  Collaboration  or   Liaising   Needed

19 ]  Any  Funding  or   within    Department   Budget   

20 ]  Quality Representative:  discusses  with  Originator 

              for further  measures ______________________

              before next management review meeting 

              dated________and / or   used 

              for next audit dated ________.             

21 ]  Request Completed / Closed / Approved 

 by Responsible personnel  ( Name )____________                

                                                        Signature______________

 before Management Review Meeting  

           due on    Date__________

(  After Closure add to   Historical  Knowledge  Bank 

        for    Learning  perspective )

22 ]  Final  Closure:

                 Further   consideration  for   effectiveness  

                      verification / validation   whether   results  

                      of   Verification  Analysis   were  successful 

                       and appropriate action.

( Date )________  

Satisfied  that   Problem   is not   Recurring 

Final Approval   

 Name___________________Signature_________