1.1 Quality System
Activities affecting quality are documented in accordance with written manuals,procedures, instructions, specifications, and drawings that contain appropriate criteria for determining whether prescribed activities have been satisfactorily accomplished.
The documentation is established in the following three distinct levels that integrate the policies, procedures, and working documents:
Level 1: QMS
Level 2: NC Electrical & Airconditioning Pty Ltd organisation policies and procedures
Level 3: Functional/Department/Plant procedures and work instructions
1.2 Quality Management System (Level 1)
The QMS is structured around interlinked processes that provide the necessary implementation controls to ensure customer and regulatory requirements are met and continual process improvement. It provides the basis for policies and procedures that implement a comprehensive quality management system. These processes are those that define activities that are directly necessary to create the item or service,and those that provide the supporting infrastructure to enable the direct processes to operate under the required controls, and continually improve.
The QMS includes commitments to address quality standards and regulatory requirements as indicated in the Applicability section. For safety-related activities affecting quality, the QMS provides for compliance with applicable quality assurance requirements imposed by the governing regulatory agency.
The QMS and changes thereto are reviewed and approved by NC Electrical & Airconditioning Pty Ltd Services management. The control of the QMS is the responsibility of the Management Representative.
1.3. NC Electrical & Airconditioning Pty Ltd Policies and Procedures (Level 2)
1.3.1. Policies and Procedures
Any activity that impacts on customers’ contractual or regulatory commitment is responsible for establishing procedures that comply with the requirements of the QMS. They are responsible for ensuring that lower-tier procedures are established as necessary to implement applicable requirements.
The Level 2 procedures governing quality-related activities are contained in a NC Electrical & Airconditioning Pty Ltd Policy/Procedures Manual. These procedures address regulatory requirements and QMS policies, as applicable. These procedures are reviewed and approved by Management.
1.3.2. Project Quality Plans
The quality requirements contained in the QMS may not address all quality systemrequirements invoked by customer contracts, or required by a governing regulatory agency, for each NC Electrical & Airconditioning Pty Ltd project. To define and implement analternate quality system for specific projects, it may be necessary to create a Project Quality Plan (PQP) to specify supplemental quality requirements, identify supplemental/revised procedures, or provide recognition and compliance with alternative quality standards. When a PQP is necessary to address these needs, or to provide more detailed information required for specific customer or market acceptance, the PQP may take the form of a complete quality assurance program manual based on the commitments of this document. For the project to which it is applicable, a PQP, in the language it is written, is the definitive quality system description and applies to activities that affect the quality of items and services supplied by NC Electrical & Airconditioning Pty Ltd .
A PQP is developed, issued, revised and controlled in accordance with established procedures; it is reviewed and approved by the responsible project manager with Quality concurrence.
1.3.3. Graded Quality
Requirements are applied as necessary to achieve the level of quality specified.Procedures identify control requirements for items and services based on the complexity of the work and safety-related function of the item or service. To ensure consistency the classification process, including safety classes, is documented in procedures. The safety class of items is documented and approved by responsible management.
1.4. Functional Procedures and Work Instructions (Level 3)
Procedures are established to implement local responsibilities in accordance with Level 2 policies and procedures for the QMS. Responsible managers ensure the preparation, approval, distribution, and revision of these procedures.
1.4.1. Work Instructions
Work instructions provide detailed steps to conduct specific work activities. Work instructions are prepared as needed to supplement procedure requirements and to ensure that critical work scopes are carried out in a consistent manner. Managers are responsible for determining where work instructions are required in their areas of responsibility and for establishing systems for the generation, review, distribution, revision, and control of work instructions.
1.4.2. Document and Data Control
Managers are responsible for ensuring that all activities affecting the quality of items and services are accomplished in accordance with controlled documents such as quality system manuals, procedures, work instructions, and controlled data such as customer order requirements. These documents contain appropriate criteria for determining whether prescribed activities have been completed satisfactorily.
Procedures are established which provide for document review, approval, issue, and changes to ensure inclusion of customer technical and quality requirements prior to implementation. All personnel are responsible for ensuring that the correct revisions of applicable industry codes and standards are used, in accordance with customer requirements.
1.4.3. Document Approval and Issue
Each manager with lead responsibility for a document or document series is responsible for establishing controls that define responsibility, authority, issue, use,and revision and control of the document or document series. Document control procedures identify (as applicable):
- Format and content guidelines;
- Requirements to ensure that documents are complete, correct, current, and in compliance with all applicable technical, quality, and administrative requirements;Individuals or organisations responsible for review and approval of documents, and revisions thereto;
- Requirements for the release and issue of approved documents to ensure that responsible personnel are promptly provided with current document revisions at the location where the document is used;
- Requirements for document effective and/or issue dates;
- Requirements for identifying what have been revised;
- Requirements for maintaining document master lists and controlled distribution list;
- Provisions for reissuing drawings after a practical number of changes have been Identified and approved for inclusion.During the document preparation and review cycle, designated personnel review documents to ensure that the requirements can be met within a timely manner once the document is formally issued.
Change to procedures, instructions, and drawings are approved and documented prior to implementation and are made available at the location where the activity will be performed prior to commencing work.
1.4.4. Quality Management System Document Control
All levels of management are responsible for assigning responsibilities to ensure that documents and data are controlled in accordance with established procedures and resolving issues pertaining to policy and procedure content, application, and use.
1.4.5. Computer Software Control
Documented procedures are established to control changes to the approved configuration of computer software used on product-related applications. The development and maintenance of computer software include documentation describing computer software requirements, computer software design, verification and validation (testing), configuration control, and error reporting and resolution.
Personnel developing or supplying computer software are required to use policies and procedures that comply with the applicable requirements of the QMS.
1.4.6. Translation of Documents
Translations of documents from, or to, a language other than English, which could have an effect on safety-related items or services, will be translated by a qualified translator. These translations will be verified and certified in accordance with established procedures.
1.4.7. Specifications and Drawings
Specifications and drawings are prepared to define design and process characteristics of items and services. The manager responsible for the design or process is responsible for determining the specification and drawings necessary to ensure compliance with customer and regulatory requirements. The manager that initiates specifications or drawings is responsible for ensuring that these documents are maintained and controlled.
1.4.8. Control of Quality Records
Quality records are completed documents that furnish evidence of the quality of items, services, and/or activities affecting quality and compliance with the QMS.
Quality records may also include articles such as materials or test specimens when required. Quality records are retained, reviewed, and provided to the customer in accordance with applicable contractual and regulatory requirements.
These quality records will be controlled in accordance with established procedures.These procedures identify the requirements and responsibilities for records classification, legibility, identification, collection, filing, indexing, storage, distribution, retention, retrieval, and disposition. Documents are considered valid records when they are validated by stamp, initialled, or signed and dated, by authorized personnel.
Handwritten signatures are not required if the document is clearly certified or otherwise authenticated as a statement by the reporting individual. Correction of quality records is in accordance with established procedures.
Records of requirements for suppliers of items and services are specified in procurement documents, as required. Suppliers’ records systems are verified and monitored during surveillance and audits.
Quality records are protected against deterioration, damage, and/or loss in accordance with established procedures, and safety-related records requiring longterm storage are maintained either at an approved single storage facility or by storage of duplicate copies at separate geographical locations.
1.4.9. Lifetime Records
Quality records are classified as lifetime if they meet one or more of the following:
- Records that would be of significant value in demonstrating capability for safe operation.
- Records that would be of significant value in maintaining, reworking, repairing,replacing, or modifying a safety-related item.
- Records that would be of significant value in determining the cause of an accident or malfunction of a safety-related item.1.4.10. Non-permanent Records
Quality records are classified as non-permanent when they show evidence that an activity was performed in accordance with applicable requirements, but do not meet any of the criteria for lifetime records.