Section 8 - Operation

8.1 Operational Planning

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting plans, implementing and controls the processes needed to meet the requirements for the provision of the products and to implement the actions determined in “Planning” process by:

Determining the requirement for products;
TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting determines and records product requirements in the form of a product specification which will be confirmed with the customer in the email train.
Establishing criteria for:

The processes;
Processes for product manufactured are recorded in work instructions, management processes are recorded in the quality manual.
The acceptance of products;
Records of product acceptance shall be obtained from customers and recorded in an email train.
Determining the resources needed to achieve conformity of the product:
The General Manager shall determine these resources.
Implementing control of the processes in accordance with the criteria;
The General Manager shall ensure processes are controlled according to the processes stipulated in the quality manual and work instructions.
Determining, maintaining and retaining documented information to the extent necessary;
To have confidence that the processes are carried out as planned;
The General Manager shall determine the extent of necessary production documentation.
The General Manager is responsible for the maintenance and retention of the production information.
The Quality Manager shall periodically check to ensure processes are carried out as planned.
1. To demonstrate the conformity of products to their requirements.
  The Quality Manager shall periodically audit products to assure conformity. The frequency of auditing to be based on risk.

The output shall be suitable for TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting operations.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects as necessary.

Actions to manage change are based on risk.

If these changes affect customer product or delivery, customers shall be informed.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that outsourced processes are controlled. See “Control of externally provided processes, products and services”.

8.2.1 Customer Communication

Communication with customers shall include;

Providing information relating to products;
This shall be recorded in an email train.
Handling enquiries, contracts or orders, including changes;
This shall be recorded in an email train.
Obtaining customer feedback relating to products, including customer complaints;
This shall be recorded in the email train. Customer complaints shall be recorded in addition in the form of any Improvement Action Request and Non Conformances.
Handling or controlling customer property.
This does not happen at TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting but at the subcontracted service company.
Establishing special requirements for contingency actions when relevant.
This shall be discussed and recorded in an email train.

8.2.2 Determining the requirements for products

When determining the requirements for products to be offered to customers, TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that:

The requirements for products are defined, including:

Any applicable statutory and regulatory requirements;
Those considered necessary by the organisation;
Customers shall be asked to provide all necessary requirements. Any uncertainties shall be negotiated and the whole recorded in a product specification for the customer to approve.

b. TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting can meet the claims for the products it offers.
Products shall be verified against specification and the results recorded.

8.2.3 Review the requirements for products

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that it has the ability to meet the requirements for products to be offered to customers. This shall include required safety, regulatory, legislative inputs. TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall conduct a review before committing to supply products to a customer; to include:

Requirements specified by the customer; including the requirements for delivery and post-delivery activities;
These activities and discussions shall be recorded in an email train. Products shall be verified against specification.
Requirements not stated by the customer, but necessary for the specified or intended use, when known;
Product specification may contain unstated requirements that are considered important by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting. Products shall be verified against specification in email format and the required specification determined by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting.
Requirements specified by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting.
Product specifications may contain requirements specified by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting. Products shall contain requirements specified by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting. Products shall be verified against specification and the results recorded in email format.
Statutory and regulatory requirements applicable to the products;
Product specifications shall contain requirements specified by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting.
Where necessary statutory and regulatory requirements shall be confirmed by an appropriate test laboratory. Standard or Codes.
Contract or order requirements differing from those previously expressed.
These shall be discussed and recorded in an email trail.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that contract or order requirements differing from those previously defined are resolved.

The customers’ requirements shall be confirmed by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE: In some situations such as internet sales, a formal review is impractical for each order.
Instead, the review can cover relevant product information, such as catalogues or web site data.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting retains documented information, as applicable:

f. On the results of the review;
Review correspondence shall be recorded in the email train.

g. On any new requirements for the product,
New product requirements shall be recorded in the email train.

8.2.4 Changes to requirements for products

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for product are changed.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that relevant people are emailed with notification of any product changes – listing the change(s).

8.3 Design and Development of products

Design

8.3.1 General

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting has established, implemented and maintained a design and development process that is appropriate to ensure the subsequent provision of products.

The Design Engineer is responsible for assuring compliance to this requirement.

8.3.2 Design and development planning

In determining the stages and controls for design and development, TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting considers:

The nature, duration and complexity of the design and development activities;
These activities are recorded in the Design Records file.
The required progress stages, including applicable design and development reviews;

The initial approach toward design and development planning is undertaken according to the project conforming to one of the following three categories:

An entirely new design
An improvement to an existing design
An existing design obtained from another supplier for manufacture under licence.

8.3.2.1 An entirely new design

The requirement for an entirely new design is formally identified by the Managing Director following input from sources comprising:

IAR forms indicating a gross market inadequacy with a present design;
Formal market research exercises suggesting the market need for such a new design;
Customer or market requests for such a product;
The noted successful introduction of such a product by a competitor;
A formal purchase order from a customer for such a design.

Upon identifying the requirement for such a product, the Managing Director convenes a Product Evaluation Meeting attended by the General Manager, and as appropriate, the Quality Manager and the Commercial Manager. At this meeting the concept of the proposed new product is presented by the Managing Director and discussed fully as to its marketing strategy, its general commercial ramifications and its known design and production requirements. Minutes of all Product Evaluation Meetings are taken and held by the General Manager in a Design Folder created for each new design.

Further Product Evaluation Meetings may be held on the same basis for the purpose of a more in depth evaluation of the new product in principle prior to a minuted decision being finally recorded as to whether or not to proceed further.

In the event that a decision is made to proceed further, a suitably qualified Design Leader is appointed by the Managing Director. Unless extraordinary circumstances dictate otherwise, the Design Leader is appointed from within the company and the appointment is for the duration of the design process per se.

The Design Leader is given a full written brief of the proposed design, this brief being prepared by the Product Evaluation Meeting as a faithful documentation and interpretation of the design input source information and design expectation criteria, determined from the Product Evaluation Meeting itself, as well as detailing design output criteria, as outlined. This brief is approved by the signatures of both the Managing Director and the General Manager. As the product evolves, the design brief may be revised, copies of all briefs issued are retained by the General Manager in the Design Folder. If the design is purely a customer commissioned one, the process of Contract Review is followed in preparing the written design brief.

Regular Design Meetings, convened by the Managing Director are held at appropriate intervals sufficient both to keep the above named staff fully informed of the design process and to permit the design leader to gain the constructive input of those staff members. The General Manager minutes all Design Meetings and retains those records. Other staff or appropriately qualified outside expertise is co-opted or retained as deemed necessary by the Design Meetings.

All concept and plans of the new design are retained in a secure place by the Design Leader and ultimately passed to the General Manager for filing in the Design Folder. Final drawings are commissioned via an approved supplier, these being prepared using the medium of computer aided design. Master design software is retained by the General Manager and issued only with his express permission.

8.3.2.2 An Improvement to an existing Design

The requirement for an improvement or modification to and existing design is formally identified by the Managing Director following input from sources comprising:

IAR forms indicating the need for a design review;
Customer or market requests for such a review;
A written notification from the designated Project Production Manager indicating the need for such a review;
The inability to continue sourcing any component or sub assembly originally specified in the design.

Should the requirement call for a minor review, the design review is conducted by way of a simple Design Review Meeting convened by the Managing Director. All Design Review Meetings are minuted by the General Manager and the proceedings held by him in a Design Review Folder, held with the original Design Folder for that product. Having conducted the Design Review Meeting, the General Manager issues promptly a written instruction to the Design Leader to arrange for the necessary revisions to drawings and Process Procedures: at this juncture, the Quality Manager is also informed of these alterations by the General Manager.

In the event that the Managing Director identifies the requirement for a major design review, a Major Design Review Meeting is convened following the identical procedure for an entirely new design.

If a new product design is offered to TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting for manufacture under licence the Managing Director convenes a Product Evaluation Meeting.

Should a decision be made to proceed further, a Design Leader is similarly nominated and a full brief of desired testing, production and modification requirements is issued via the Managing Director, approved by the Managing Director.

The Design Evaluation process follows that of an entirely new design with the major difference being that the design effort itself is confined to minor revisions necessary to comply with market and regulatory requirements and that Type Approval/Testing organisations external to the company may be commissioned to solicit critical judgement or issue safety approval as the case may be.

8.3 Design Process

8.3.3 Design Input

The Design Leader is responsible for the identification and documentation of any relevant statutory, regulatory or contract review requirements that may have relevance to the design. The Design Meeting carries the overall burden of verifying the validity and adequacy of the identified requirements.

8.3.4 Design Output

Final designs are presented to a duly convened design meeting whereupon the meeting conducts a final critical assessment of the design documentation and proposed process procedures against the terms of the current version of the written design brief. This assessment verifies the following pints of compliance:

The design output conforms to the written brief;
The design output complies with the brief’s documented acceptance criteria;
The design output contains clearly identified statements as to the safe and proper functioning of the product e.g. full and clearly understood operating instructions, also documenting any regular maintenance needed, stated procedures for any special storage or handling requirements the product may have, and any special other requirements e.g. safe disposal after use.

Should the design conform fully, the meeting formally approves the design and the final version Design Documentation is approved by the dated signature in red ink of the Managing Director, the Design Leader and the Managing Director.

The Design Output Documents are then released for production.

Design Review

At the regular Design Meetings, formal documented reviews of the design output are conducted against the criteria of the written design brief, these reviews being recorded in the meeting minutes.

Design Verification

During the process of the regular Design Meetings, verification is performed and minuted to document that the design stage output is meeting the specified requirements. Any design verification measures used are also recorded and include any or all of the following:

Comparison of the design with a similar proven design;
The presentation of test results;
The conducting of demonstrations;
Reviewing design stage documents on a regular basis prior to final release.

Design Validation

The end product of the design process is validated to ensure that it conforms to the requirements of Design Input and the Contract Review processes, as applicable. Validation follows successful design verification and is performed under specific defined operating conditions as may be required under the terms of the design input. Validation is performed on the final design product wherever possible, unless documented circumstances dictate it is carried out prior to completion.

Design Changes

All design changes are identified, documented, reviewed and approved by authorised personnel prior to implementation.

8.4 Control of externally provided processes, products

8.4.1 General

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting ensures that externally provided processes, products conform to requirements.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting determines that the controls applied to externally provided processes, products when:

Products from external providers are intended for incorporation into TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting own products;
Products are provided directly to the customer(s) by external providers on behalf of TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting.
A process or part of a process, is provided by an external provider as a result of a decision by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting determines and applies criteria for the evaluations, selection, monitoring of performance, and re-evaluation of eternal providers, based on their ability to provide processes or products and in accordance with requirements. TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting retains documented information of these activities and any necessary activities arising from the evaluations.

These shall be discussed and recorded in an email train.

The interface and approval process for external providers is recorded in an “Approved Supplier Check-list”.

All regular suppliers are assessed and approved, at least, annually, to ensure that their services remain acceptable. This assessment is based on:

A history of acceptable past performance and the ability to supply goods or services to the specifications of TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting;
Registration of the supplier/sub-contractor to a recognised Quality System (e.g. ISO 9000); Registration of the supplier/sub-contractor to a recognised Quality System (e.g. ISO 9000);

A List of all approved Suppliers/Sub Contractors is compiled, assessed and approved, by the Quality Manager prior to being posted on the TR Lord and Associates t/a AVO New

Zealand, LORD Power Equipment and LORD Consulting website with the Quality Manual. A master copy of this List is retained by the Quality Manager and is updated as necessary.

8.4.2 Type and extent of control

Purchasing

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting ensures that externally provided processes or products do not adversely affect our ability to consistently deliver product to our customers.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall:

Ensure that externally provided processes remain within the control of our quality management system;
Define both the controls that we intend to apply to an external provider and those we intend to apply to the resulting output;
Material received from an external provider shall be checked at inwards goods and at the introduction to any subsequent processing.
Take into consideration:
- The potential impact of the externally provided processes, products on TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting ability to consistently meet customer and applicable statutory and regulatory requirements;
- The effectiveness of the controls applied by the eternal provider;
Determine the verification, or other activities, necessary to ensure that the externally provided processes, products meet requirements.
Material received from an external provider shall be checked at inwards goods and at introduction to any subsequent processing. Quality shall be further evaluated during production testing.

8.4.3 Information for external providers

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting ensures the adequacy of requirements prior to our communication with the external provider.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting communicates to external providers our requirements for:

The processes, products to be provided;
The approval of:
1. Products;
2. Methods, processes and equipment;
3. The release of products;
Competence, including any required qualification of persons;
The external providers interactions with TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting;
Control and monitoring of external providers’ performance to be applied by TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting;
Verification or validation activities that TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting intends to perform at the external provider’s premises.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting documents and records the above where appropriate in an email train.

8.5 Production provision

8.5.1 Control of production provision

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting implements production provision under controlled conditions.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting currently assemble PAT420Kits and PAT150’Kits. This involves the taking of multiple stock items and assembling as a single stock item, resulting in associated stock adjustments.

The QMS recognizes this requirement as well as the need for associated quality testing and control of the process. On completion of assembly, items are quality checked and the checklist signed off and retained.

Controlled conditions shall include, as applicable;

The availability of documented information that defines;
1. The characteristics of the products to be produced, (product specifications) or the activities to be performed; (work instructions)
2. The results to be achieved; (test instructions)
The availability and use of suitable monitoring measuring resources;
The implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products have been met; (as described in product work and test instructions)
The use of suitable infrastructure and environment for the operation of processes;
The appointment of competent persons, including any required qualification;
The validation and periodic revalidation, of the ability to achieve planned results of the processes for production provision, where the resulting output cannot be verified by subsequent monitoring or measurement; TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting periodically validates product performance with results documented in the Design Engineers work books.
The implementation of actions to minimise human error. These actions are incorporated into work instructions.
The implementation of release, delivery and post-delivery activities. Release is implemented by exception i.e. Product is approved for release provided there are no hold notices connected with the product.

8.5.2 Identification and traceability

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting uses suitable means to identify outputs when it is necessary to ensure the conformity of products. These means are identified in product work instructions. The statue of outputs with respect to monitoring requirements throughout the production provision. Where statue is not obvious, product is labelled. Release is implemented by exception i.e. product is approved for release provided there are no hold notices.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting identifies the statue of outputs with respect to monitoring and measurement requirements throughout the production provision. Where status is not obvious, product is labelled.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting controls the unique identification of the outputs when traceability is a requirement and retains the documented information necessary to enable traceability. Traceability is achieved by way of serial numbers on all Megger stock items as well as all relating purchase order numbers and email train.

8.5.3 Property belonging to customers or external providers

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting exercises care with property belonging to customers or external providers while it is under TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting control and treat instruments with special care as not to further damage items.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting identifies, verifies, protects and safeguards customers’ or external providers’ property provided for use or incorporated into products.

When property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting reports this to the customer or external provider and retains documented information on what has occurred. Documented information is retained via emails.

A customer’s or external provider’s property can include components, equipment, intellectual property and personal data.

8.5.4 Preservation

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting preserves outputs during production to the extent necessary to ensure conformity to requirements.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting ensure items are stored correctly not allowing any deterioration.

Preservation can include identification, handling, deterioration, packaging, storage, transmission or transportation and protection.

8.5.5 Post-delivery Activities

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting meets requirements for post-delivery activities associated with our products.

In determining the extent of post-delivery activities that are required, TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting considers:

Statutory and regulatory requirements;
The potential undesired consequences associated with our products;
The nature, use and intended lifetime of our products;
Customer requirements;
Customer feedback.

Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance and supplementary services such as recycling or final disposal.

8.5.6 Control of changes

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting reviews and controls changes for production to the extent necessary to ensure continuing conformity with requirements.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting retains documented information describing the results of the reviews of changes, the person(s) authorising the change and any necessary actions arising from the review.

8.6 Release of products:

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting implements planned arrangements at appropriate stages to verify that the product requirements have been met.

The release of products to the customer shall not proceed until the planned arrangement have been satisfactorily completed, unless otherwise approved by a relevant authority and are applicable to the customer.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall retain documented information on the release of products and services.

The documented information shall include:

Evidence of conformity with the acceptance criteria;
Traceability to the person(s) authorizing the release.

8.7 Control of nonconforming outputs

8.7.1

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.

Non-conformance may be a result from a deviation from the specified product requirements and/or procedures detailed in the TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting Quality System Manual.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to non-conforming products and services detected after delivery of products, during or after the provision of services.

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting shall deal with nonconforming outputs in one or more of the following ways:

Immediate correction and reprocessing
Segregation, containment, return or suspension of provision of product and services;
Informing the customer; for concession to the client or client’s representative.
Obtaining authorization for acceptance under concession. Any product that is reprocessed is re-inspected accordingly.

Upon identification of a non-conformance, an Improvement Action Request (IAR) Form will ensure that the non-conformance is investigated to determine the root cause and reviewed to determine its disposition and prevent future recurrence.

An Improvement Action Request (IAR) Form may be raised for product checking/testing equipment or machinery that is found to be defective or out of calibration. Non-conforming product in the Inwards Goods Store is isolated, tagged with a copy of the IAR and segregated to an isolation area in storage clearly marked “Non-Conforming Product Area’.

Conformity to the requirements shall be verified when nonconforming outputs are corrected.

In the event of a customer complaint an Improvement Action Request (IAR) Form is raised by the staff member receiving the complaint and an appropriate Senior Manager notified.

8.7.2

TR Lord and Associates t/a AVO New Zealand, LORD Power Equipment and LORD Consulting 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.

In Australia

Postal Address

Worldwide

Delivery Address

In New Zealand

Delivery Address