Standartisation Procedures (excerpt)

1.1 Non-conformity, corrective and preventive actions

1.1.1 Arisen or hypothetical problems shall be documented in XXXXXXX

1.1.2 Any employee who has established difficulties in his/her activity due to the organization, the intra-company communication or any other issue shall report to his/her direct supervisor or MR. When it has been reported to the direct supervisor, the latter shall notify the MR. MR in his/her own discretion, shall register the problem in XXXX and follow up its development until its final removal.

1.1.3 While documenting an arisen or hypothetical problem detailed information shall be submitted regarding: the nature of the problem (it shall be described by a manager / auditor / MR); the circumstances under which it has arisen or is expected to arise (it shall be described by a manager / auditor / MR), including reasons for arising, prescribed corrective and/or preventive actions (it shall be described by an auditor / MR); employee in charge of the performance (it shall be described by an auditor / MR); deadline for performance (it shall be prescribed by an auditor / MR); effectiveness valuation of the undertaken corrective action -  not later than 30 days from the closing date of the corrective/ preventive action. (it shall be checked by an auditor / MR)

1.1.4 When identifying a problem message submitted to the “Suggestions and signals mail-box” the proceedings shall follow the manner specified in p. 7.3.3. of the present procedure.

1.1.5 Documenting the corrective actions after internal and external inspections of the MS shall follow the rules specified above.

1.1.6 The corrective actions shall be entered in form XXXX maintained by MR.

1.1.7 In case of accidents of fatal outcome and serious incidents the proceedings shall follow Instruction No. 15.1.1. as well.

Share