Environment Monitoring
1.0 PURPOSE
1.1 Though the raw material and packing materials are not monitoring is required for conditioning of raw material and to mitigate risk identified during risk assessment.
2.0 SCOPE
2.1 This SOP applies to Store section of Warehouse department and production (process) areas.
3.0 REFERENCE(S) & ATTACHMENTS
3.1 References
3.1.1 In-house
3.2 Attachments
3.2.1 Attachment- I : Temperature Monitoring Record SIPL/WHS/006/F01/00
3.2.2 Attachment- II : Hotspot Identification Form SIPL/WHS/006/F02/00
4.0 RESPONSIBILITY
4.1 Warehouse Department Person:
4.1.1 To prepare the SOP.
4.1.2 To prepare a list of the SOP in Warehouse Department.
4.2 Production Head:
4.2.1 To ensure the training of the SOP to all concerned department personnel involved in implementation of the SOP.
4.2.2 To ensure the implementation of the SOP after training.
4.3 Quality Assurance Person:
4.3.1 To check the SOP.
4.3.2 To maintain the original copy of the SOP.
4.3.3 To issue controlled copy of the SOP.
4.3.4 To maintain issuance record of SOP.
4.3.5 To retrieve the controlled copy of the SOP when it is superseded/obsolete and maintain its record.
4.4 QA Head:
4.4.1 To approve new or revised SOP.
4.4.2 To ensure the implementation of the defined system.
4.5 Plant Head:
4.5.1 To approve new or revised SOP.
4.5.2 To ensure the implementation of the defined system.
5.0 DISTRIBUTION
5.1 Quality Control
5.2 Production
5.3 Warehouse
6.0 DEFINITION(S) & ABBREVIATION(S)
6.1 Definitions
6.1.1 Material Conditioning: Material conditioning is to keep the material in the same environment in which it is to be processed for at least 12 hrs. prior to processing. As the primary packaging materials are flexible, they are likely to retain the environment in which they are stored. If they are suddenly processed in a different environmental condition, certain properties may not be achieved, e.g. flexibility, formability, repeat length, etc.
6.2 Abbreviations
6.2.1 °C: Degree Centigrade
7.0 PROCEDURE
7.1 Do not issue the raw material on the very same day it is received in Store, even if it is passed by Quality. In case of urgency, an
7.2 Keep the material in the RM/semi-finish stores properly (preferably in a hanged position) wrapped with poly/bubble sheet.
7.3 Ensure that the material is not kept in a wet place. Aluminium foil may get corroded if directly in contact with water.
7.4 Keep the temperature of the warehouse preferably close to the temperature in the next process area so that the material gets conditioned.
7.5 Temperature of the RM warehouse/main process area should be less than 30 °C of the hotspot area.
7.6 Check the current temperature on the digital temperature display installed in the hotspot area.
7.7 Record the temperature up to one decimal, for example 26.3, 27.8.
7.8 Record the temperature on a daily basis, two times: once in the morning between 09.00 AM and 11.00 AM, and then between 02.00 PM and 5.00 PM.
7.9 The signature of the person recording the daily temperature should be there.
7.10 Analyze the record for the entire month after completion of the month.
7.11 Procedure to Identify the Hotspot Area in Warehouse:
7.11.1 The testing will be done after the completion of 6 months, not exceeding the 7th month.
7.11.2 Procedure of testing:
7.11.2.1 This test will be done in the presence of the QA Head and Operations Head.
7.11.2.2 The QC Assistant will perform the test.
7.11.2.3 The test shall be performed with the help of a calibrated temperature measurement instrument.
7.11.2.4 The QC Assistant will take the instrument and test the temperature between 02:00 PM and 03:00 PM at the below-mentioned areas of the warehouse:
Point Location
1 Front left corner
2 Front right corner
3 Centre between front left & right corner
4 Back left corner
5 Back right corner
6 Centre between back left & right corner
7 Room centre
8 Centre between front left & back left corner
9 Centre between front right & back right corner
7.11.2.5 The above temperature readings shall be filled in the format of Attachment- II.
7.11.2.6 The high temperature found in Attachment- II will be the hotspot area.
7.11.2.7 After approval by all persons, a thermal hygrometer will be installed there.
8.0 REVISION HISTORY
+----------------+----------------+----------------+----------------+----------------+----------------+ | Revision No. | 00 | Effective | | CC No. | | | | | Date | | | | +----------------+----------------+----------------+----------------+----------------+----------------+ | Details of revision: New SOP | +-----------------------------------------------------------------------------------------------------+