Archipelago Food & Beverages Inc.: Site Master File
Archipelago Food & Beverages Inc.: Site Master File
Archipelago Food & Beverages Inc.: Site Master File
1. GENERAL INFORMATION
2. SPECIFIC INFORMATION
2.1 PERSONNEL
2.1.1 ORGANIZATIONAL CHART (Taken from DLCI Org chart, if still applicable with archipelago, if
not, please provide one)
2.1.2 ORGANIZATIONAL CHART FOR PLANT (Taken from DLCI Org chart, if still applicable with
archipelago, if not, please provide one)
a. The Quality Assurance Manager is responsible for the overall planning and
implementation of quality control measures that focus on potential problem
prevention and routine testing of all company resources (ingredients, raw materials,
components, packaging materials, packed products, customer support, etc.) to
ensure adherence to set standards. This includes the continual development,
maintenance and improvement of tasks and procedures over the company’s various
processes, projects, production, selling and other activities.
c. The Quality Assurance Officer is primarily responsible for the implementation of the
procedures designed to ensure that materials have passed inspection and testing
before use, and that products have successfully undergone quality control testing.
e. The Quality Inspector is responsible for the random inspection of sample products
at critical sample and control points during production. This position also ensures
that adherence to standards are maintained in the process.
f. The Production Manager is responsible for planning, organizing and controlling the
general conduct of work and activities related to the manufacture of company
products in conformity with established standards. A holder of a Bachelor’s Degree
in Engineering or equivalent with minimum of five (5) years managerial experience
in a manufacturing firm and/or quality assurance.
i. The Production Workers are responsible for providing labor/services needed by the
Production, Maintenance, Housekeeping, Warehouse and Utility.
b. Conduct training needs analysis and identifying the training needs of the employees
and decides which seminar can be internally conducted and which will be facilitated
by an outside consultant/institution.
b. Any person suffering from intestinal or respiratory disorder or disease is not allowed
to handle food. The Leadman or the QA Officer is notified for proper action. A
medical clearance is presented before a sick person can resume handling food
products.
c. Production staff is required to wear protective clothing to protect products from risk
of contamination and not to keep their own clothes clean. These protective clothing
must not be worn outside production premises.
d. There is a suitable hand washing, dressing room and rest room for all factory
workers. Clear procedures and work instructions are provided for maintaining
cleanliness in all areas.
2.2 PREMISES
2.2.1 Grounds
Good housekeeping is properly implemented. Bottling facilities and other equipment must be
cleaned regularly to prevent water scaling and build-up of slime. All equipment used for bottling should
be cleaned before and after each operation. It should be cleaned internally and externally. To prevent
the spread of bacteria and collection of debris, floors and walls should be cleaned daily with soap and
water. Use swirling motion changing direction frequently and intermittently. Loose soil must be
immediately rinsed off. Clean small surfaces at a time so water rinse can be applied before the detergent
dries off. Remove all materials and supplies from the work area that would hamper cleaning efficiency.
All efforts should be made to prevent insoluble products and other materials from being hose-washed
into the drainage line. Disinfect the area with chlorine-based solution after the cleaning process.
2.2.2 Plant Construction and Design (AFBI May insert floor and structural plan on this area)
2.3 EQUIPMENT
2.3.1 List of Equipment with Corresponding Description.
a. Major Production and Quality Control Facilities
• Compounding Tank – used in compounding of liquors, alcoholic beverages and
juices.
• Filtration Tank – used in filtering compounded mixtures.
• Ortho-Rinsing Machine – used in preliminary rinsing of bottles to remove
bottle bloom.
• Rotary Rinser Machine – used in final rinsing of bottles before they are fed to
the bottling line.
• Filler Machine – all products that are ready for bottling will pass through this
equipment.
• Capper Machine – used in capping all bottled products.
• Labeling Machine – used in labeling all bottled products.
• Ink Jet Printer – used in coding all bottled products for traceability.
• Pick and Place Machine – used in picking up and holding the bottled products
for insertion into the carton.
• Hot Melt Adhesive Machine – used in carton sealing.
• Check-weigher – used to make sure that all finished cartons complete and are
within weight range.
b. Laboratory Equipment
• Gas Chromatography Machine – for testing purity of alcohol.
• Top Loading Balance – used in weighing the required amount of samples for
testing.
• pH Meter – used in laboratory test of finished product.
• Density Meter – used in laboratory test of finished product.
• Refractometer – used in laboratory test of finished product.
• Hydrometer – used in laboratory test of finished product.
• Turbidimeter – used in laboratory test of finished product.
• Spectrophotometer – used in laboratory test of finished product.
• TDS Meter – used in testing deionized water.
• Conductivity Meter – used in testing deionized water.
• Acid/Base Burette – used in testing deionized water.
• Torque Tester – used to measure the tightness of caps.
• Vernier Caliper – used to measure packaging materials.
• Steel Rule – used to measure packaging materials.
• Alcoholometer – used to measure the percentage of alcohol.
• Specific Hydrometer – used to measure the specific gravity of raw materials.
AFBI ensures that all Monitoring and Measuring Resources (MMRs) are properly controlled,
calibrated, and maintained to demonstrate the conformance of our products to specified requirements
through documented procedures in accordance with our quality plan.
The MMRs shall be selected on the basis of their measurement uncertainties. Qualified
personnel will ensure that all MMRs are calibrated at the specified frequencies or interval against
certified equipment traceable to nationally or internationally recognized standards.
The QA manager shall define the process employed for the calibration of MMRs including details
of equipment type, unique identification, location, frequency of checks, check method, acceptance
criteria, and the actions to be taken when results are unsatisfactory. Previously documented inspection
and test results shall be assessed and validated when MMRss are found to be out of calibration.
AFBI ensures that environmental conditions are suitable for the calibration, inspection,
measurement, and test being carried out. AFBI also ensures that the handling, preservation, and
storage of the inspection, measuring, and test equipment are maintained for accuracy and fitness, and
safeguards from unauthorized adjustments invalidating the calibration settings in place. Records of
calibrations are maintained. Calibrated MMRs are identified with stickers indicating the date and status
of calibration.
AFBI ensures that the bottling area and equipment are sanitized properly to maintain the good
quality of the product. The production area is also ensured to be free from any microorganisms. The
procedure starts from the time the production run ends up to the sanitation of equipment in
preparation for the succeeding bottling runs. Daily cleaning and sanitation are performed. Cleaning and
sanitation checklists are updated and records of the following are filed: Daily Bottling Checklist, Daily
Janitorial Services Checklist, and Cleaning and Sanitation Checklist.
a. Water Supply – Potable and from approved sources, sufficient and with adequate
pressure in all areas.
e. Disinfection facilities.
2.5 DOCUMENTATION
2.5.1 Procedures for the Preparation, Revision, and Distribution of Necessary Documentation for
Manufacturing.
a. Documents and data related to the quality system shall be reviewed and authorized
before being issued to the personnel concerned. Any changes or modifications of
existing documents shall be reviewed and approved. Obsolete documents and data
are withdrawn from all points of issue or use.
b. Document and Data Control Custodian is responsible for the preparation, revision,
and distribution of documents.
d. Standard format and instructions on how the documents are prepared are present,
such as:
e. This procedure covers the evaluation of the needs for documentation, coding of the
document, and withdrawal of obsolete documents. Revised documents are
reviewed and approved by the person who is in the same position that did the
original review and approval. Update the master list of controlled documents.
Reproduce copies of the document according to the number of copyholders.
Withdraw obsolete copies of documents from copyholders. Distribute reproduced
copies of documents or new manual. File original copies of obsolete documents.
Original copies of obsolete documents will be kept for a period of ten (10) years,
after which these will be discarded. Obsolete documents shall be marked
“OBSOLETE COPY” on all pages with red ink.
d. Training Procedures
g. Validation Documents
Batch numbering must be controlled to ensure that a unique batch number is assigned to each
production bottling batch. Batch numbers should be assigned starting with 001 for the first batch of the
calendar year. Each subsequent batch should be numbered consecutively. At the beginning of the next
calendar year, batch numbers should again begin with 001.
Batch codes are printed on one side of the case and on the bottle.
Example: 8050810300007
8 – last digit of current digit 1
calendar year
2.6 PRODUCTION
2.6.1 Description of Manufacturing Procedure and Identification of Critical Control Points. The
objective is to be able to come up with a plan to manufacture and make for sale needed wine and liquor
that meet customer requirements at company set standards. This procedure starts from the review of
stock request from the distributor and customer’s requirements, up to the distribution of final
production plan.
Finished goods inventory level is checked to determine how long the inventory level will last.
Production is scheduled according to inventory level followed by preparation of production plan.
Production plan is distributed to all concerned departments in order to prepare all the materials
needed. Availability and condition of all machines and equipment are also checked for readiness for
bottling operation.
2.6.2 Procedures and Work Instructions are prepared for the Handling of the following:
a. Raw Materials – subject for laboratory test before accepting incoming raw
materials.
c. Bulk and Finished Product Quarantine, Release, Storage, and Rework Items.
e. Identification of Supplier’s lot number with the company’s lot number – identified
through incoming material inspection report.
i. In-process checks.
k. Storage.
2.6.4 Quarantine and Release of Finished Products are under the responsibility of QA
Department.
2.6.5 Procedures and Work Instructions for the handling of rejected materials and products are
prepared by QA and Warehouse Department.
b. Rejected materials and products are properly stored separately in restricted areas.
c. Disposal of rejected materials and products are decided after re-evaluation. All
destroyed materials and products are properly recorded for easy identification.
Ensures that all incoming materials and finished products are in good quality and conforms to
the established standards and specified requirements.
b. Inspection and Testing of Raw Materials, In-process, and Finished Products – after
inspection and testing, whatever the results will be the final disposition. This activity is
strictly implemented.
d. Sample Retention Program – store the retention samples inside the cabinets of the
storage room. Storage plan is provided for easy identification, retrieval, and disposal of
samples. Samples retained for more than three years are to be disposed.
e. Stability Studies – all new products are subject to stability testing to come up with our
quality standards and meet our requirements.
g. Product Recall – The key aspect of the product recall procedure is that the product
is traceable throughout the distribution system. This is implemented by way of
product coding on all the bottles, cases, and pallets for identification in the
warehouse. The Manufacturing Department must notify the distributor to freeze
and hold deliveries of all products with the specific product code in question. The
distributor immediately sends messages by telephone, fax, or messenger services to
depots and sub-distributors to freeze and hold deliveries of products in question. It
reconciles distribution records against total production batch and locates where
products in question were dispatched depending upon the seriousness of the
defect. On the basis of re-evaluation of the product batches in question, the
manufacturing department decides as to the need to issue a recall advisory notice.
In case of product recall, the distributor mobilizes a fleet of delivery vehicles to
facilitate product pull-out, proper handling, and safekeeping pending final
disposition or return to DLCI warehouse.
d. Product Controlled – by indicating the status of every designated product in the label.
f. Dispatch order ensures first-in, first-out method. This activity identifies the
corresponding lot number.
2.8.2 Security of Stocks – defective stocks and market returns are properly labeled once it is
endorsed back to the AFBI warehouse. An investigation and re-evaluation follows before
final disposition is made.
a. Complaints
• Responsibility for logging is with the receiving party thru phone calls, walk-in,
or thru the distributor. The complaint is then referred to the QA Manager to get the
details about the complaint. The complaint is attended to by securing a copy of the
complaint form and as much as possible, the matter should be settled at this level. The
cause of the complaint in the product in question is investigated then corrective and
preventive action reports are prepared. The QA Manager will then review the reports
made before informing the customers of what action was taken or if needed, request
the customer to sign “Quit Claim.” Complaint records are kept for a lifetime for future
reference.
b. Procedure of Recalls
Description of Product Recall Procedure:
Retrieval of distribution of data
Notification of customers
Receipt of segregation of returned product
Investigation/reporting of cause
Reporting of corrective action
• Manufacturing Department is responsible for coordinating product recalls.
• Traceability of records of packaging materials, processing date, and
laboratory results are traceable throughout the distribution system. Reports
must carry the identification of the batch so that any problem found
subsequent to manufacture can be related to the specific production run.
• Storage condition of retention samples must be maintained properly.