Page 19 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]
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QUALITY MANUAL
PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED
DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE
PPTL/QM/001 02 01 14.12.2018
8.0 Operation
8.1 OPERATIONAL PLANNING AND CONTROL
The organization shall plan, implement and control the processes needed to meet the requirements for the provision
of products and services, and to implement actions by:
• Determining the requirements for the products and services.
• Establishing criteria for the processes and the acceptance of products and services. The criteria shall be set in
terms of Key Performance Indicators within the departments.
• Determining the resources needed to achieve conformity to the products and service requirements.
• Implementing control of the processes in accordance with criteria.
• Determining and maintaining documented information to the extent necessary to have confidence that the
processes have been carried out as planned and to demonstrate the conformity of products and services to
requirements. All of these is by implementing risk-based thinking, internal audit procedures, opportunities for
improvement and management review using the QA SOPs stated above.
The output of this planning shall be suitable for PPTL operations. The organization shall control planned changes and
review the consequence of unintended changes taking action to mitigate any adverse effects as necessary. This shall
be done using the Change Control Procedure as stated in SOP Number PPTL/SOP/QA/007. A procedure on
subcontractor management PPTL/SOP/QA/011 and a procedure for supplier prequalification PPTL/SOP/BD/007 has
been established to ensure all outsourced activities are controlled.
8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES
8.2.1 CUSTOMER COMMUNICATION
Communication with customers shall include the following:
• Providing information relating to products and services.
• Handling enquiries, contract or orders including changes.
• Obtaining customer feedback relating to products and services, including customer complaints.
• Handling or controlling customer property.
• Establishing specific requirements for contingency actions where relevant.
Methods and procedures as covered by the SOP Number PPTL/SOP/CS/003 – Customer Inquiries and Feedback
along with a Price List have been identified and implemented to communicate with customers on information
about the products and services, to deal with enquiries, contracts or order handling, including amendments,
customer feedback and complaints.
8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES
The requirements including service requirements specified by the customer are determined when receiving
orders as stated in the SOP Number PPTL/SOP/CS/002 – Receipt of Orders. In particular, consideration is given
to:
• The extent to which customers have specified the requirements of the product/service example: expiry
date of products.
• Customer requirements, availability of the product, collection, delivery and support example: delivery
times.
• Requirements not specified by the customer but necessary for fitness and purpose example: monitoring
of the warehouse and transit temperature and humidity.
• Obligations related to product, and service including statutory and legal requirements example:
licensing of the Pharmacists, fire safety, etc.
• Any additional requirements determined by PPTL.
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