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3. Responsibility   

3.1??????????

   a) ???????????????????

   b) ???????????????????????????

c) ?????????????????????б????

d) ????????????

e????????????????????鵵??

3.1 Change Application Department     

a. Apply to the department in charge of change;   

b. Be in charge of supplying supportive materials for application of change;       

c. After the change is approved, carry out the training before change and implement the change;   

d. Follow-up after the change is implemented; 

e. Collect related data and submit them to the Quality Inspection Dept. for placing on file;    

3.2?????????????????

   a) ???????????????б????????

b) ??д??????棻

   c) ???????????????

   d)????????????в?????б????????

e)??????б??????????????

3.2 Competent Department for the System of Change

a. Organize staff of related departments in carrying out the change appraisal;

b. Complete the appraisal report; 

c. Be in charge of reviewing the items of change; 

d. After the change is approved, the Supervision Implementation Department shall implement the change;     

e. Organize re-appraisal after the change is implemented.    

3.3?????

a) ??????????????

b) ??????????

    c )??????????????????????????????

d) ???????????鵵???檔

e????????

3.3 Quality Assurance Department

a. Participate in the appraisal of change; 

b. Review the items of change;

c. Supervise the implementation process of change and trace and confirm part of the change; 

d. Place on file of the changed related materials; 

e. Approve the change. 

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