OTC COSMETIC INDUSTRIES SDN BHD

Doc No. : QC-FM-089

INTERNAL SELF AUDIT Rev. : 02
CHECKLIST Date : 25th January 2023

Date of audit : ________________

Department / Section Audited: _______________

PARTICULARS COMPLY COMMENTS

YES NO
1.0 PERSONNEL
- All personnel are properly attired
- All safety equipment is used correctly
- There are no significant language barriers between
supervisors and operators
- The employees are capable of reading and
understanding all company documents used in
the production of the products
- All injuries are immediately reported to the
employee's supervisor
- No jewelry and cosmetics are worn

2.0 MANUFACTURING PREMISES

- There is adequate lighting
- There is adequate ventilation
- There are adequate screens and controls to
prevent infestation
- Physical separation exists for operations requiring
dust collection, solvent control and temperature
and humidity control
- There are adequate personnel washing, locker,
and toilet facilities.
- There is adequate space provided for the
placement of equipment and materials in the
following areas:

(a) Receiving and sampling, storage of raw

materials
(b) In-process and production operations and
materials
(c) Storage areas for containers, packaging
materials, quarantined material, and released
final product.
(d) QC laboratory operations, equipment, retain
samples and records

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OTC COSMETIC INDUSTRIES SDN BHD

PARTICULARS COMPLY COMMENTS

YES NO
3.0 RECEIVING AND STORAGE
- Receiving records for raw materials or components
include
(a) Name of component or material
(b) Manufacturer or supplier
(c) Receiving date
(d) Manufacturer's lot number
(e) Quantity received
(f) Control or purchase number
(g) A stock rotation policy is in place
(h) Proper storage conditions are used for all
the materials
(i) All the raw materials and components are
properly labelled
(j) There is a receiving procedure that is followed
and a list of personnel authorized to receive
items
- Raw materials and components are labelled,
sampled, and placed in quarantine according to
written procedures; only authorized personnel
have access to the quarantine areas
- There are written procedures that indicate how
rejected materials or components are handled

4.0 IDENTIFICATION
- Each component or raw material is identified
- Each component or raw material has a purchase
order or control number that, when cross-checked
to the receiving records, will identify the
(a) product
(b) supplier
(c) quantity received
(d) purchase or control number
(e) date of receipt
- Q.C labels are complete and affixed to each
container, as appropriate
- Accurate inventory records are kept for all
approved components and raw materials

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OTC COSMETIC INDUSTRIES SDN BHD

PARTICULARS COMPLY COMMENTS

YES NO
5.0 EQUIPMENT
- There are no mechanical parts that come in
contact with the product that will react, add to,
be absorptive, or adversely affect the identity,
strength, quality or purity of the product
- The equipment is constructed in such a manner
that lubricants or coolants required for the
operation of the equipment may be used without
becoming incorporated into the product
- The equipment is constructed or located in such
a manner as to permit necessary cleaning,
adjustments and maintenance
- The equipment is constructed or located in such
a manner as to exclude possible contamination
from previous as well as current production
operation
- The equipment is thoroughly cleaned before use
and identified to indicate that it is ready for use
- The equipment is of suitable capacity and
accuracy for use in the intended measuring,
weighing or blending operations
- The weighing equipment is properly calibrated
- Utensils and in-process containers are constructed
in such a manner as to permit thorough cleaning
- Responsible supervisors or QC inspectors
approve the equipment and areas prior to the
start of production or packaging operations
- Responsible supervisors or QC inspectors are
present while the equipment is in operation

6.0 PRODUCTION
- Each critical step in the production process is
performed by a responsible individual, and
checked by a second responsible individual
- The automatic, mechanical or electronic
equipment used in the processing is routinely
checked and documented by responsible
individuals
- There is record to show that adequate
blending time was used, providing a uniform
compound prior to further processing

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OTC COSMETIC INDUSTRIES SDN BHD

PARTICULARS COMPLY COMMENTS

YES NO
- There is adequate documentation to show that in-
process samples were collected and tested as
per the batch records
- The determination of actual yield has been
calculated and recorded on the batch records
- Fully competent and responsible personnel check
the actual yield against the theoretical yield of
each batch or lot
- The formulation and processing areas are manned
by competent responsible individuals who are
trained in the procedures required to prevent
cross-contamination
- Weighing operations are carefully supervised and
require two signatures on all weighing steps
- There are documented cleaning schedules for the
equipment and areas used in production
- There is documentation to show that the cleaning
of the equipment and the areas used for
production are adequate to prevent cross-
contamination
- Approved cleaning compounds are used for the
cleaning of all equipment used in the production
- Product containers are not left open or
unattended
in the production areas for any length of time
- All areas, equipment and containers will be
completely labelled at all times to identify fully
and accurately their
(a) batch or lot number
(b) contents
(c) stage of processing
- All previous identification labels have been
removed
- The batch or lot is handled in such a manner as
to prevent the cross-contamination of the material
with any other material
- All in-process containers are labelled for use and
labels are removed prior to reuse

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OTC COSMETIC INDUSTRIES SDN BHD

PARTICULARS COMPLY COMMENTS

YES NO
7.0 PACKAGING AND LABELLING OF PRODUCT
- There are documented specifications for all
containers, closures, cartons and component parts
- Only approved containers, closures, cartons,
and component parts are used in the packaging
operations
- The containers provide adequate protection for
the product from deterioration or contamination
- There is adequate storage space and inventory
control of all packaging materials prior to use
- Packaging and labelling operations are adequately
controlled to assure that only those products that
have met all the QC specifications and have been
released will be packaged and labelled
- There is adequate physical separation of the
packaging and labelling lines

8.0 WAREHOUSING
- Finished products are stored under sanitary
conditions and adhere to "First In First Out"
procedures
- The shipping and storage areas are maintained
under proper temperature and humidity
conditions
- Stock rotation is used to prevent outdating of
products and to avoid product deterioration
- An approved rodenticide and insecticide program
is in place
- The warehouse area is maintained in a clean and
orderly manner and is secured at all times

9.0 QUALITY CONTROL LABORATORY

- There are written specifications for all raw
materials used in the production.
- The laboratory is staffed with competent,
responsible personnel and equipped with the
appropriate instruments necessary to test raw
materials, in-process samples, and final product
in a scientific and accurate manner

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OTC COSMETIC INDUSTRIES SDN BHD

PARTICULARS COMPLY COMMENTS

YES NO
- Representative samples are collected from the
production operation and retained until the
product is released
- Specifications for final product testing and release
are documented
- Documentations exists for all outside laboratory
testing
- A calibration program exists that checks the
reliability, accuracy and precision of laboratory
instruments
- There are procedures for the acceptance or
rejection of raw materials, in-process samples and
final product
- There are complete records of all laboratory tests
performed, including dates and signatures of the
individuals completing the assays, and the
individuals who verified the assays for accuracy
- There are procedures for retain samples
- Stability studies have been performed on all
products
- There are no errors in the laboratory records; and
all test failures have been investigated and
recorded

10. DOCUMENTATION
- All specifications, procedures and policies are
available and properly stored
- Each document is current, approved and subject to
periodic review
- There is a proper change control mechanism
- There is a proper distribution procedures to
preclude the use of out-dated documents
- All documents are effectively controlled by all
departmental heads

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PARTICULARS COMPLY COMMENTS

YES NO
11. QC/QA RESPONSIBILITES
- There is proper documentation for the handling of
all returned products
- If the material is to be destroyed, it will be
documented and destroyed by two competent
individuals under the supervision of the QC Dept.
- A customer complaint system is in place and will
be utilized to track all product complaints and to
take all product complaints and to take the
appropriate corrective action.
- There is a recall procedure and documentation
for all products involved in recalls
- All batch records and packaging and labelling
records will be reviewed by Quality Assurance
prior to the final release of the product for
shipping
- There is a central file where all distribution
records are maintained
- There is a documented GMP and SOP training
program for all employees

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