General

Scope

The procedure “Control of nonconforming product” is prepared by FrieslandCampina Russia in line with requirements of ISO FSSC 22000.

The procedure describes how to identify and control nonconforming product including incoming raw materials, intermediate and final product.

Objective of this procedure is to manage of nonconforming product as per ISO FSSC 22000 requirements that include activities to eliminate the detected nonconformity, authorize its use, release or acceptance by a relevant authority and preclude its original intended use or application.

The procedure defines the controls and related responsibilities and authorities of the Supply chain and Operations Director, SHEQA, production, maintenance, logistics for dealing with nonconforming product.

Abbreviation

SOD SD - Supply chain and Operations Director

SHEQA- SHEQA & Food Safety department

PD – Production

MD – Maintenance department

WI – Work Instruction

General

Management of nonconforming product is considered as a process that has inputs, outputs, targets, monitoring and records.

3.1. Inputs for identification of nonconformance are:

ð Results of incoming raw materials control

ð Results of intermediate product control

ð Results of final product control

3.2. Outputs are:

ð Losses analysis

ð Analysis of effectiveness of correction

ð Data information for improvement of technological process, suppliers performance, maintenance programs competent level

ð Management review

3.3.Targets:

ð Rejected product (quantity) is defined in Year Plan

ð Effectiveness of the production lines (time losses) is defined in the procedure “Facilities, Maintenance, and Calibration of equipment”

ð Proper documentation of all quality records concerning control of nonconforming product

3.4.Monitoring is carried out regularly. It includes:

ð Daily review of quality records by SHEQA & FoodSafety Manager

ð Daily morning meeting

ð QC/PD/MD meetings

ð Daily reporting by PD and MD (Losses of raw materials, intermediate and final product, waste, downtimes)

In case of any parameters maintained by software are outside the norms during production the equipment is stopped automatically, the intermediate product in thrown away. (For more detailed information see Control Plans).

Decision regarding disposition of nonconforming final product is taken during daily morning meetings and fixed in Selection list. (Please, see WI Hold of nonconforming product QA-FS-WI-023). Selection list is updated on daily base and covers all nonconforming product produced during a week. The information registered in Selection list is input for Quality and Production meetings.

If the SOD SD is to be involved in the issues concerning disposition of nonconforming product the decision is taken during daily Morning meeting

When nonconforming product is detected after delivery the company performs recalls in compliance with Corporate Policy.

Definition:

A Quality Incident is when there are more than 10 complaints from the market, more then 50000€ costs or more than 11 tons of milk involved.

3.5.Records relative to control of nonconforming product are as follows:

ð “Production control (Yoghurt)”QA-PC-RF-002,

ð “Hold report” QA-FS-WI-014 (Annex 1), QA-FS-WI-055 (Annex 1),

QA-FS-WI-012,

ð “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,

ð “Yoghurt. Yeast/mould after incubation” QA-MB-RF-009, QA-MB-RF-010, QA-MB-RF-020,

ð “Final product (Yoghurt)” QA-PC-RF-004,

ð “CL. Batch filling report GEA” PD-FS-CL-011,

ð “CL. Product control GEA” PD-FS-CL-019,

ð “CL. Batch filling report BOSCH” PD-FS-CL-015,

ð “CL. Product control BOSCH” PD-FS-CL-016,

ð “CL. Batch filling report Finnah” PD-FS-CL-001,

ð “CL. Product control Finnah” PD-FS-CL-002,

ð “CL. Batch filling report Hamba” PD-FS-CL-053,

ð “CL. Product control Hamba” PD-FS-CL-054,

ð “CL. Batch filling report Quark” PD-FS-CL-055,

ð “CL. Product control Quark” PD-FS-CL-056,

ð “CL. Batch filling report Bosch 2” PD-FS-CL-301,

ð “CL. Product control Bosch 2” PD-FS-CL-302,

ð “CL. Batch filling report Elpo” PD-FS-CL-404,

ð “CL. Product control Elpo” PD-FS-CL-405,

ð “RF Operator’s work form” PD-FS-RF-018

ð “RF. Batch list” PD-FS-RF-016

ð “RF. Daily produced product” PD-FS-RF-017

ð “WI Quality passport” QA-FS-WI-007 (Annex 1,2)

ð “Selection List“ QA-FS-WI-023 (Annex 2)

ð Other

The process of nonconforming product control is reflected in flow-charts1, 2:

1. Management of nonconforming raw materials is carried out in line with WI “Hold of nonconforming raw materials”.

2. Control of intermediate and final product is fulfilled according to WI “Hold of nonconforming product” and WI “Quality passport”.

Flow-chart “Control of nonconforming raw materials”