8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
The company’s quality philosophy involves a “do it right the first time” approach rather than inspecting quality into the product at a later stage.
To control its provision of products and services, AGE considers, as applicable, the following:
| Item | Control Element |
|---|---|
| A | Availability of documents or records that define the characteristics of the products and services as well as the results to be achieved |
| B | Availability and use of suitable monitoring and measuring resources |
| C | Implementation of monitoring and measurement activities |
| D | Use of suitable infrastructure and environment |
| E | Appointment of competent persons, including any required qualifications |
| F | Validation and revalidation of special processes if applicable |
| G | Implementation of release, delivery and post-delivery activities |
| H | Establishment of criteria for workmanship |
| I | Accountability for all products during production |
| J | Control and monitoring of identified critical items, including key characteristics, in accordance with established processes |
| K | Determination of methods to measure variable data |
| L | Identification of in-process inspection/verification points when adequate verification of conformity cannot be performed at later stages |
| M | Availability of evidence that all production and inspection/verification operations have been completed as planned |
| N | Provision for the prevention, detection, and removal of foreign objects |
| O | Control and monitoring of utilities and supplies to the extent they affect conformity to product requirements |
| P | Identification and recording of products released for subsequent production use pending completion of all required measuring and monitoring activities |
Where special requirements, key characteristics and/or critical items are identified or deemed appropriate, the processes will be planned and controlled to manage these aspects.
8.5.1.1 Control of Equipment, Tools and Software Programs
Equipment, tools, and software programs used to automate, control, monitor, or measure production processes are validated prior to final release for production and are maintained.
Special storage requirements, if applicable, are defined for production equipment or tooling including any necessary periodic preservation or condition checks. This is further defined in the Validation of Equipment procedure.
8.5.1.2 Production Process Verification
New Production processes are validated prior to use or implementation. This may include:
- Running test products through the new process or equipment
- Performing a First Article Inspection on a part produced by the process, tooling or equipment
First Article is discussed further in QSM-8.6.3.
8.5.2 Identification and Traceability
Where appropriate, AGE identifies its product and service or other critical process outputs by suitable means. Such identification includes the status of the product and service with respect to monitoring and measurement requirements.
Unless otherwise indicated as nonconforming, pending inspection or disposition, or some other similar identifier, all product and service shall be considered conforming and suitable for use.
Traceability Requirements
If unique traceability is required by contract, regulatory, or other established requirement, AGE controls and records the unique identification of the product and service. This shall include, as appropriate:
| Item | Traceability Element |
|---|---|
| a) | Product identification to be maintained throughout the product life |
| b) | The ability to trace all products manufactured from the same batch of raw material or the same manufacturing batch, to the destination (delivery, scrap) |
| c) | For an assembly, the ability to trace its components to the assembly and then to the next higher assembly |
| d) | For a product, a sequential record of its production |
All production materials will be adequately identified on receipt and during storage, pending issue, and use.
All products in production will be identified by either:
- Work order
- Shipping order
- AGE part numbers
When required by engineering drawing or by contract, finished products will be individually identified by:
- AGE model number
- Manufacturing date
- Serial number
Model number, serial number, and date of manufacture for all system products are recorded on a Serial Number Log.
8.5.3 Property Belonging to Customers or External Providers
AGE exercises care with customer or supplier property while it is under the organization’s control or being used by the organization.
All customer property (parts supplied by customers for their products, or returned material for repairs and upgrade) will be examined upon receipt for:
- Condition
- Quantity
- Conformance with delivery details
All items will be positively identified and stored by location in the stockroom or appropriate location in the case of RMA units. These will be handled and stored in a manner which will avoid damage or deterioration.
If any lost or damaged material and/or material shortages are identified during the receiving process, the customer will be notified in written form.
Customer intellectual property, including customer furnished data used for production and/or inspection, is identified by customer and maintained and preserved to prevent accidental loss, damage or inappropriate use.
8.5.4 Preservation
AGE preserves conformity of product during internal processing and delivery to the intended destination. This preservation includes:
- Cleaning
- FOD (Foreign Object Debris) control
- Special handling for sensitive products
- Marking and labeling including safety warnings
- Shelf-life control and stock rotation
- Special handling for hazardous materials
Preservation also applies to the constituent parts of a product.
8.5.5 Post-Delivery Activities
As applicable, AGE conducts the following post-delivery activities:
- Repair of product under warranty
- Customer training when applicable
Post-delivery activities are conducted in compliance with the management system defined herein. In determining the extent of post-delivery activities required, AGE considers:
- Statutory and regulatory requirements
- The potential undesired consequences associated with its products and services
- The nature, use and intended lifetime of its products and services
- Customer requirements
- Customer feedback
- Collection and analysis of in-service data (e.g., performance, reliability, lessons learned)
- Control, updating, and provision of technical documentation relating to product use, maintenance, repair, and overhaul
- Controls required for work undertaken external to the organization (e.g., off-site work)
- Product/customer support (e.g., queries, training, warranties, maintenance, replacement parts, resources, obsolescence)
When problems are detected after delivery, AGE takes appropriate action including investigation and reporting per QSM-10.2.
8.5.6 Control of Changes
AGE reviews and controls both planned and unplanned changes to processes to the extent necessary to ensure continuing conformity with all requirements.
- Process change management is defined in the document Change Management
- Documents are changed in accordance with procedure Control of Documented Information per QSP-7.5.3