The document outlines comprehensive cleaning, sanitation, and organizational procedures for a testing and research facility, emphasizing traceability of materials, pest control, internal audits, and GMP practices. It details the necessity for proper handling of raw materials and finished goods, along with customer service protocols and supply chain control measures. Additionally, it includes procedures for quality control during production, maintenance of equipment, and the importance of adhering to established standard operating procedures (SOPs).

1. Sigma Test & Research Centre

2. Cleaning & Sanitation

3.  Daily / weekly, Master cleaning schedule for all
equipments, general area and building.
 Spring / Master cleaning frequency
 Cleaning records duly signed by staff and
supervisor

4. Traceability

5. Material Traceability
SOP for tracing Raw Material,
ingredients, primary packaging must
be laid
Each product must be traceable back
and forth

6. Product Recall

7.  SOP must be in place for performing Product recall and
withdrawal.
 Product Recall costs 50 Billion Dollars each year
worldwide
 Recently, car manufacturers Toyota, General Motors,
and Honda have suffered the embarrassing
consequences of product recalls. In addition to the
automobile industry, product recalls have also occurred
in the food, medicine and consumer electronics
industries.

8. Product Coding, Return,
Salvaging
 Must have procedure for detailing the
requirement of finished goods, case, carton,
pallet: code and date label
 Written procedure for return, receipt, storage
and control of return products.
 Rejected products are effectively destroyed and
documented for record keeping and future
reference.

9. Pest Control

10.  Must have SOP on pest control that takes care of rats,
insects and birds
 Inspection records to be maintained along with
documentation of corrective action taken and its effects
after pest control treatment
 Installation of rat traps in receiving docks, entryways.

11.  Installation of fly traps and regular cleaning of the
equipment with documentation and operational bulbs
always.
 Installation of Air Curtains at employee entrance
 Storage inside the plant must not contribute to rodent
harborage

12. Internal Audit

13.  An Internal Audit must be held once a year.
 There must be a Master Schedule for Internal Audit.
 An Audit Manager is required to oversee the procedure.
 Qualification & Training needs for the internal audit
staff to be laid in black and white

14.  Auditors need to be independent of the area where
audit is being conducted
 There must be a procedure in place to track
corrective action and ensure timely follow up for the
findings from the reports and same must be
documented

15. GMP / Personal Practices

16.  Personal Protective Equipment must be worn by
employees, contractors and visitors always in the site.
 Proper Uniform to be worn by the staff in the designated
lab.
 Warning signs to be installed and clearly visible to avoid
accidents.
 Designated Hand Washing area and staff need to wash &
dry hands before returning to work.

17.  Employee suffering from infectious illness need to refrain
from entering labs.
 Doctor’s medical certificate stating fitness of the employee
while returning to work.
 Designated food storage and consumption area and need
to be clean and well maintained.
 No employees to be allowed to eat or drink in the lab or
production area.

18. Customer Service

19.  A Happy Customer is a Returning Customer
 Facility to keep & maintain Customer Service and
complaint process well documented.
 It includes internal communication, investigation, and
timely response.
 Effectively work on feedbacks to improve the services
 Fact:- Very few customers complain rest never turn up
again and approach our competitors instead.

20. Supply Chain Control

21.  There must be SOP for handling inspections, testing,
and acceptance of incoming materials as per set
specification prior to use.
 Rejected materials to be controlled and stored
separately from usable materials.
 Non-Conforming Products:- SOP to identify, quarantine
and dispose off nonconforming items to avoid accidents.
 SOP for rework handling process and subsequent
documentation for future reference.

22. Raw Material & Finished
Goods
 Prevent deterioration of stored materials by
monitoring
1. Physical Storage Condition.
2. Temperature.
3. Humidity.
4. Pallet Spacing.
5. Appropriate positioning to avoid cross
contamination.

23.  No raw materials to be stored outside the facility
temporarily or permanently in containers with or without
covers.
 FIFO First In First Out to be always maintained to
maintain the quality of the product.
 Storage Inspections- Material area need to be routinely
inspected for the storage condition, product condition,
cleanliness and housekeeping and to be documented for
corrective actions if need be.

24.  Vendor Approval:-
1. Facility need to have documented Vendor
Approval Process for raw materials, ingredients.
2. Facility need to have vendor performance
evaluation system to critically analysis and
assess vendors for quality and timely product
delivery.

25. Good Lab Practice

26. Laboratory Methods
 Appropriate test methods must be available for
testing all the materials and products.
 Must have specific procedure laid for handling out of
specification test results.
 A finished good retain sample program must be in
place
 All lab equipments and instruments needs to be
calibrated as per the calibration schedule.

27.  Calibration Standards are traceable to National
Standards.
 The Facility must have procedure for handling products
produced with lab equipment that is found to be out of
calibration.
 The lab mixtures are verified regularly to ensure the
validity for use.
 There must be documented program to verify analyst’s
proficiency.

28. Inspection & Testing
 The products needs to be tested as per the
specifications and well documented.
 Labels are examined for identity before labeling
operations to avoid mix-up.
 The equipment for processing, transfer and filling the
utensils, and the containers for holding raw and bulk
materials are clean, in good repair and in sanitary
condition.

29. Production & Process
Control

30. Process & Quality Control
 SOP for the Manufacturing of the product. It must
detail all the activities starting from issue of the raw
materials till the formation of the final product.
 It must include in process quality monitoring
methods, frequency of checks and verification
compliance
 Ensure Quality checks of products are conducted by
trained staff and well documented for corrective
action, if any.

31. Control of Inspection,
Measuring & Test Equipment
 An Identification system must be in place for all
process equipments to know the equipments that
require calibration.
 Above said process needs to be well documented with
the frequency of inspection.
 Reference Standard needs to identified for critical test
equipments.
 Equipments to be calibrated against certified industry
Standards.
 Documentation for future reference for corrective
actions, if any.

32. Maintenance

33.  Facility to have SOP for Preventive Maintenance program. It
must include a list of critical production equipment, the
frequency and accountability for maintenance.
 The Maintenance program must include work instructions for
preventive maintenance.
 The Breakdown Maintenance records to be kept for all the
machines and to be reviewed time to time.
 Refrain from using temporary repairs such as duct tape, or
cardboard on machines.

34. Contact Us
99, Badli Industrial
Area, Phase 2, New
Delhi, Delhi 110042
+91 - 9560222333
mail@sigmatest.org

35. Thank You
https://www.sigmatest.org