Product development/Product modification/Modification of

Production Processes
Scope: A procedure for product development shall be in place which incorporates the hazard
analysis principles, in accordance with the HACCP and/or risk assessment system. Product
formulation/configuration, manufacturing processes, process parameters and the fulfilment of
product requirements shall be established and shall have been assured by factory trials and
product testing.

Reference: IFS PACsecure 4.3

Procedure:

Xxxxxxxxxxx has developed a program for the development of new products. New product
developments and changes to formulations must first be approved by senior management. Any
customer requirements shall be formulated into the new or existing products. If an ingredient
must come from a new supplier the required information for our supplier approval must be
retrieved prior to the product being run. HACCP and risk assessment must be completed before
new products are allowed to be produced for trials.

A risk and HACCP assessment shall be conducted for all new products that are created. If the
new products require additional control measures, they shall be implemented to ensure that the
product safety and legality is controlled and maintained. Only new equipment that changes the
way that products are made shall require a risk and HACCP assessment. Newly purchased
equipment is to be first approved by senior management as long as it does not alter the existing
HACCP plan; risk and HACCP assessments are not required.

 Note: new equipment that does not change the way our products are made must still be
approved by senior management before it is allowed to run products.
 Note: product changes that do not alter the existing HACCP plan do not require risk and
HACCP assessments to be done before the product is produced.

New product specifications shall be developed, reviewed, and approved by senior management.
All changes to the specification sheets are reviewed annually by senior management, including
any testing that was required to confirm that the specs are still valid. Returned products are
tested to ensure that they still meet our specifications before they are reshipped or repackaged.

 Note: unless changes to existing products change the specification sheet, the product
shall not require a new specification sheet. Changes to the limits allowed on the spec
sheets that are not of significant specifications shall not be considered a new product or
product change. These changes shall be determined by senior management.

Xxxxxxxxxxx has assessed our products and the items that will be packed into them. As not all
of our products are for food, the assessment has been completed for our products that will
interact with food. Our products are either clear film or preprinted film. The risk assessment has
shown that there is no risk to food products that are packed in our clear film (See risk

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Issue Date: Prepared By: Approved By:
Revision Date: Revision # : 1
 assessment). Products that will be placed in our preprinted film have undergone testing to
ensure that there’s no risk of the ink contaminating the product packed in the bag from the film.

Our R&D department is responsible for keeping up-to-date with the most current changes and
developments in the packaging industry. Our Sales department is to ensure that customer
requirements are relayed to both our Production and R&D departments. Both R&D and Sales
are responsible for ensuring that our existing products and new products conform to the legal
standards of the country they are exported to.

Risk assessment for organoleptic testing is not required.

Revalidation Specification: Currently the management of change is not required when changes
or correction is needed since the prior formula/specification that were pulled out or transfer from
the previous data system were not uploaded correctly. The production team composed of
Specialist and Supervisors are reverifying the master data correctness and this is on going as
we produce the product for accuracy.

Specific details for the following management of change:

A. New Product Introduction developed by R & D:

1. R & D/Technical Manager will initiate a new product introduction.
2. The 4.3.2 form will be followed /filled up before the trial begins.
3. If the trial is accepted by the customer, The new product specs will be submitted to
SAP Master Data team to create a new product.
4. Once the new product is created production will commence.

B. New Product modification as per customer requirements:

1. Sales Manager will provide the Information to Planning as per customer requirements.
2. Specs will be validated by Specialist and Production using the form.
3. Verified specs will be submitted to SAP Master Data team to create a new product.
4. Once the new product is created production will commence.

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Issue Date: Prepared By: Approved By:
Revision Date: Revision # : 1