Table 1

Logistics (Purchase)     Logistics (Purchase)	8

Flow-chart “Control of intermediate and final nonconforming product”

Table 2

Responsibility	Flow-chart of the process	Records
QC, PD   QC, PD     QC, PD     QC, PD, Maintenance     PD, Maintenance     QD     QD     QD, PD, SOD   PD	1     Detection of nonconforming product Identification, registration and holding of nonconforming product Analysis of reasons, evaluation of possibility and practicability of correction 5 8 Disposition of nonconforming product             Resumption of production       9 Release to the market after selection. Selection. Results registration in Selection List 7 10	Input is - Results of intermediate product control - Results of final product control - Control Plans - WI “Hold of nonconforming product”, WI “Quality passport”, WI “Batch list filling”, CL “Product control”, RF “Technical problems form”. 1,2,3,4,5,6,7. “Production control (Yoghurt)”QA-PC-RF-002, “Stress-test” QA-MB-RF-002 “Control of yoghurt in incubation chamber” QA-MB-RF-009, QA-MB-RF-010, QA-MB-RF-020, QA-MB-RF-026, QA-MB-RF-033, QA-MB-RF-034, QA-MB-RF-03; “Check of industrial sterility of final product” QA-MB-RF-028, QA-MB-RF-036, “Yoghurt. Yeast/mould after incubation” QA-MB-RF-009, QA-MB-RF-010,QA-MB-RF-020 “Final product (Yoghurt)” QA-PC-RF-004 “CL. Batch filling report GEA” PD-FS-CL-011 “CL. Product control GEA” PD-FS-CL-019 “CL. Batch filling report BOSCH” PD-FS-CL-015 “CL. Product control BOSCH” PD-FS-CL-016 “CL. Batch filling report Finnah” PD-FS-CL-001 “CL. Product control Finnah” PD-FS-CL-002 “CL. Batch filling report Hamba” PD-FS-CL-053, “CL. Product control Hamba” PD-FS-CL-054, “CL. Batch filling report Quark” PD-FS-CL-055, “CL. Product control Quark” PD-FS-CL-056, “CL. Batch filling report Bosch 2” PD-FS-CL-301,

Table 2

QC     QC   QC   PD	11           Release to the market without selection. Change of product status in Advantics Navision     Change of product status - Advantics & Navision         14 12	“CL. Product control Bosch 2” PD-FS-CL-302, “CL. Batch filling report Elpo” PD-FS-CL-404, “CL. Product control Elpo” PD-FS-CL-405, “CL Operator’s work form” PD-FS-RF-018 “RF. Batch list” PD-FS-RF-016   8,9,10,11. “Selection List“ QA-FS-WI-023 (Annex 2) Information is registered in “Advantics” and “Navision”   12,13,14. Information is registered in “Advantics” and “Navision” 15. “WI Quality passport” QA-FS-WI-007 (Annex 1,2)   Information is registered in “Advantics” and “Navision” Outputs are: - Process improvement, - Correction and corrective actions, - Competence improvement, - Data analysis, - Management Review

4. Responsibilities

4.1. The levels of delegation and responsibilities are reflected in the Control plans.

4.2. The managers of the departments where nonconforming product have been found are responsible for:

ð Any steps to eliminate the nonconformity

ð Communication and information of personal concern

ð Preclusion of its unintended use or delivery

4.3. The SOD SD is in charge of coordination between departments.

4.4. In complicated cases QC Manager’s decisions override decisions of other managers.

4.5. Final decision for disposition of nonconforming product rests with SOD SD.