Sigma Test & Research Centre

Cleaning & Sanitation

• Daily / weekly, Master cleaning schedule for
all equipments, general area and building.

• Spring / Master cleaning frequency

• Cleaning records duly signed by staff and

supervisor
Traceability
 Material Traceability
• SOP for tracing Raw Material, ingredients,
primary packaging must be laid

• Each product must be traceable back and

forth
Product Recall
• 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.
 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.
Pest Control
• 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.
• Installation of fly traps and regular cleaning of
the equipment with documentation and
operational bulbs at all times.

• Installation of Air Curtains at employee entrance

• Storage inside the plant must not contribute to

rodent harborage
Internal Audit
• 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
• 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
GMP / Personal Practices
• Personal Protective Equipment must be worn
by employees, contractors and visitors at all
times 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.
• 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.
Customer Service
• 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.
Supply Chain Control
• 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.
 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.
• 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 maintained at all

times to maintain the quality of the end 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.
• 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.
Good Lab Practice
 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.
• 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.
 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.
Production & Process Control
 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.
 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.
•
Maintenance
• 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.