Skip to main content
Version: 2.2

8. Operation

8.1 Operational planning and control​

AAPMC establishes and implements documented plans and procedures that describe the processes (4.3) and the controls required for the provision of services in awareness to the objectives, the potential for planned or unintended change, and the risks and opportunities identified in Section 6.1.

During this planning phase, management or other responsible personnel identify the following parameters:
  • Objectives and requirements for the service;
  • Verification, validation, monitoring, inspection and test requirements;
  • Documented information to demonstrate conformity;
  • Document information to demonstrate process effectiveness;
  • Necessary resources; or outsourced processes and their controls;
  • Criteria for process performance and product/service acceptance;
  • Potential consequences and mitigation to change affecting input requirements;
  • Resources necessary to support the ongoing operation of the service.

The output of planning activity includes documented plans, resource schedules, process, requirements and procedures.

8.2 Requirements for products and services​

8.2.1 Customer communication​

In accordance with our commitment to exceed our customer’s expectations, AAPMC highlights effective customer communication as an essential element of delivering customer satisfaction. Appropriate handling of customer communication helps to reduce customer dissatisfaction and in many cases turn a dissatisfying scenario into a satisfying experience. Customer communication occurs through the following formats, events and processes:

  • Website, specifications or technical documents relating to our products and services;
  • Inquiries, quotations and order forms, invoices and credit notes;
  • Confirmation of authorised orders and amended orders;
  • E-mails, letters and general correspondence;
  • Customer feedback and complaints management process;

Top management is responsible for establishing methods of communication with our customers to ensure enquiries, contracts or order handling; including amendments, customer feedback and complaints are handled expeditiously and professionally.

8.2.2 Determining the requirements for products and services​

AAPMC develops appropriate requirements to ensure that we satisfy the needs and expectations of our customers or relevant interested parties. AAPMC ensures that customer requirements are clearly articulated and that their requirements are captured and understood before the acceptance of an order. Customer requirements include the following:

  • Previous customer requirements
  • Statutory and regulatory requirements related to the product;
  • Other non-customer specified performance requirements;
  • Any additional requirements determined by AAPMC;

8.2.3 Review of the requirements for products and services​

8.2.3.1 Requirements and commitment​

Prior to committing to the customer, AAPMC ensures and confirms our capacity to supply the required product or service. Pre-acceptance reviews are conducted to ensure that:

  • Product requirements are defined and are appropriate;
  • Any additional requirements determined by AAPMC are appropriate;
  • Contract or order requirements differing from those previously expressed are resolved;
  • AAPMC has the ability to meet the defined requirements;
  • Documented information is retained and maintained showing the results of the review.

Customer requirements are confirmed before acceptance by the exchange of contracts, purchase orders via appropriate electronic or hard copy formats.

8.2.4 Changes to requirements for products and services​

AAPMC ensures that all relevant documented information; relating to changes in product or service requirements, is authorised and amended where necessary, and that all relevant personnel are made aware of the documented requirement changes.

8.3 Design and development of products and services​

Not Applicable

Design and development is not covered by the QMS because AAPMC currently does not engage in any design and development processes and procedures.

8.4 Control of externally provided processes, products and services​

8.4.1 General​

The purchasing process is essential to our organisation’s ability to provide our customers with products and services that meet their requirements. AAPMC ensures that all purchased products or services that are incorporated in to our final products; conform to our specified requirements.

AAPMC accomplishes this by closely working with a network of external clients. Performance and capability are continually assessed through periodic performance data analysis and inspection or verification of the supplied services. The type and extent of control applied to our suppliers and the purchased service is dependent upon the effect that the outsourced service may have on our final service. The following considerations are taken in to account by:

  • Ensuring that we understand the capabilities and competencies;
  • Ensuring that we clearly communicate the roles and responsibilities;
  • Defining the quality requirements for the outsourced activity;
  • Selecting and qualifying appropriate suppliers.
  • Ensuring that no counterfeit production products are supplied to the organization

It is the responsibility of the Top management to evaluate and select suppliers based on their ability to supply services in accordance with specified requirements. Additionally, other internal resources may be called on to assist as required. The criteria for the selection, evaluation and reevaluation are defined in the Purchasing & Procurement Procedure, while records of the results of evaluations and any necessary actions arising from the evaluation are maintained.

8.4.2 Type and extent of control​

Purchased items are checked against the purchase order to confirm identity and quantity. In the event that items are rejected on receipt, a non-conformance report is raised and the supplier contacted to arrange replacement or credit. AAPMC has established and implemented a process of inspection to ensure that purchased products conform to:

  • Purchase orders and delivery notes;
  • Product specifications;
  • National or international standards.

Where appropriate, risk control measures are applied to outsourced processes. Risk control measures, and their importance, are documented within the purchasing data and clearly communicated to the supplier.

8.4.3 Information for external providers​

AAPMC uses purchase orders to describe the service to be purchased. Designated individuals within the company create purchase orders using the company system. They also ensure the adequacy of the requirements that are specified by the purchase order prior to release. Each purchase order includes where appropriate:

  • Identification of product or service to be delivered, quantity, delivery date, and cost;
  • Requirements for approval or qualification of product, procedures, processes or equipment;
  • Requirements of the quality management system and the qualification of personnel.

8.5 Production and service provision​

8.5.1 Control of production and service provision​

In order to control the planning, administrative support and implementation of work, AAPMC’s policy is to describe the work methods, the controls applied and the records required. The process control activities are quality with many aspects that also relate to quality control. The following controlled conditions are applied where applicable:

  • Quality control checks are performed;
  • Evidence of completed inspections;
  • Detailed process work instructions and specifications for all products;
  • Criteria for workmanship and competence.

In cases where special processes are employed where the results of which cannot be easily checked, including any processes where deficiencies become apparent only after the service is in use. Validation demonstrates the ability of these processes to achieve planned results by:

  • Defining qualification criteria and approval of special processes prior to use;
  • Defining criteria for review and approval of the processes;
  • Approval of equipment and qualification of personnel;
  • Requirements for records;
  • Re-validation.

8.5.2 Identification and traceability​

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

8.5.3 Property belonging to customers or external providers​

We identify, verify, protect and maintain customer property provided for use. The Compliance Manager ensures that lost, damaged or unsuitable customer property is recorded and immediately reported to the customer.

Customer property can also include customer-owned materials, tools (including packaging), tooling (including test/inspection tooling and equipment), and intellectual property.

8.5.4 Preservation​

The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.

8.5.5 Post-delivery activities​

AAPMC determines customer requirements before acceptance of an order. Customer requirements include the following:

  • Previous customer requirements;
  • Statutory and regulatory requirements related to the product;
  • Any additional requirements determined by AAPMC.

8.5.6 Control of changes​

Changes to the design and development requirements are identified and recorded. Any changes are reviewed, verified, validated and approved. The review of design development changes includes evaluating the effects of those changes upon constituent products already delivered. All results relating to the review of changes are retained as documented information.

8.6 Release of products and services​

Top management has overall responsibility for planning and implementing the inspection and test activities needed to verify that product requirements are met at appropriate stages of the product realisation process.

Services are not used until verified as fully compliant. Documented information is retained to indicate the person authorising the release of the service. Service delivery does not proceed until all compliance have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.

Measurement and acceptance criteria that are necessary for service acceptance are retained as documented information; subsequent acceptance records form the production documentation evidence which includes the following information:

  • Criteria for acceptance and rejection;

8.6.1 Usage of Controlled Stamps as Confirmation​

Controlled Stamp usage by employees across all operations and departments is to be implemented for faster and more efficient way of tracking and documenting process flow.

Stamp usage is recognized as equivalent to employee officially signing off a document. If used through an external document, additional information such as Full Name shall be required.

Departments are represented by the following code:

  • Production - PXXX
  • Engineering - EXXX
  • Quality - QXXX
  • Administration - AXXX

where XXX denotes the control number of the stamp

8.7 Control of nonconforming outputs​

8.7.1 Nonconformances​

It is our organisation’s policy to detect, control and rectify any aspect of an output that does not conform as quickly and efficiently as possible. Where necessary, any service output that does not conform to requirements is properly identified and controlled to prevent unintended use. The nonconformity is analysed and the cause(s) are investigated.

Improvement actions are implemented to ensure the non-conformance does not reoccur. Once the non-conforming outputs are corrected, the outputs are then verified for conformity against requirements. Documented information concerning the nature of any non-conformances, the resolving authority, and the resulting corrective actions is retained. Where necessary, details concerning any authorised concessions are documented as evidence of acceptance.

8.7.2 Recording of Nonconformances​

The organization shall retain documented information that:

  • describes the nonconformity;
  • describes the actions taken;
  • describes any concessions obtained;
  • identifies the authority deciding the action in respect of the nonconformity.