5.5 Any change proposed as a result of CAPA shall be through the SOP on Change Control. Reference of the same shall be mentioned in the CAPA format. 5.6 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form. 5.7 All facility up-gradations / Capital pu...
3. Document this information in FMEA and control plan format. Its organization suggests that it can appear side by side with the work instructions in, for example, spreadsheet format. The worker doesn’t have to see this information for routine activities, but it should be available to him or...