200720 - LORAN QUALITY MANAGEMENT SYSTEM MANUAL - PART 2

QUALITY MANAGEMENT SYSTEM (QMS) – REQUIREMENTS

ARTICLE 1.    SCOPE

ARTICLE 2.    NORMATIVE REFERENCES

ARTICLE 3.    TERMS AND DEFINITIONS

Term

Definition

Article

Material, part, component, assembly, or appliance which is listed by the design organization as eligible for installation in/on the product or included in the design data approved by the authority.

Authorized Release Certificate

Document attesting that a product is released for use (e.g., release or return to service) and certifying that the activities performed, and the results achieved, conform to established organization, regulatory, and customer requirements.

Nonconformance

A condition of any article, material or service in which one or more characteristics do not conform to requirements specified in the contract, drawings, specifications, or other approved product description. Includes failures, discrepancies, defects, anomalies, and malfunctions. Loran Aerospace uses the SAE AS9131 (Rev.D) Aerospace Series - Quality Management Systems - Nonconformity Data Definition and Documentation for Nonconformance processes.

Disposition

Appropriate action to resolve the nonconformance.

Product Safety

Maintaining the state of product so that it is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.

Splitting

The division of product either physically or by batch quantity, without affecting the product characteristics or conformity.

Test Report

Documented information that shows objective evidence provided by either the manufacturer or a certified testing facility that the product conforms with specific design requirements, product or performance characteristics.

Unapproved Part

A part that was not produced or maintained in accordance with approved or acceptable data and applicable statutory, regulatory, and customer requirements.

CAR

Corrective Action Report

Root Cause

The fundamental deficiency or failure of a process that when resolved, prevents or significantly reduces the likelihood of recurrence of the problem.

Root Cause Corrective Action

Root cause corrective action (RCCA) is an effective process for finding the causes of an event and facilitating effective corrective actions to prevent recurrence.

8D Problem Solving

A problem-solving model establishes a permanent corrective action based on statistical analysis of the problem and focuses on the origin of the problem by determining its root causes. Although it originally comprised eight stages, or disciplines, the eight disciplines system was later augmented by an initial planning stage. The purpose of the 8D methodology is to identify, correct, and eliminate recurring problems, making it useful in product and process improvement. Loran Aerospace uses the SAE AS13000 (2014-05) Problem Solving Requirements for Suppliers Standard for CAR processes.

Failure Event

The failure event is a description of the problem that Loran team is analyzing.

Supplier

External provider of goods, processes or services. This may include outsourced services, contract employees, and vendors. The party to the purchase agreement supplying material, parts, assemblies, subassemblies, systems, or services in accordance with the provisions of the purchase order.

Approval Status

Currently there are three possible approval status designations, i.e., Approved Supplier, Conditionally Approved Supplier, and Cancelled Supplier.

Approved Supplier

Suppliers whose have a score depending on the on-time delivery and product quality with a minimum of 75 or Maximum 1 product rejection within a year.

Conditionally Approved Supplier

They are the suppliers classified as supplier can supply the products of Purchase Exceptional or the supplier whose newly starts the work with Loran and will deliver their first products. Their supplier score is between 50-75.

Cancelled Supplier

Suppliers whose scores are below 50. The cancelled supplier term covers all companies that provide counterfeit products and or forge traceability documents, and or cannot provide adequate technical support and warranty.

Approval Scope

Approval scope indicates the process(s), product(s), service(s) and/or product/service family(s)for which the supplier is approved.

Purchase Order

The document that details the entire purchase agreement. These may include, but is not limited to, procurement documents such as contract work orders, purchase agreements and referenced documents such as specifications, trace documentation, maintenance manuals, tear down lists etc.

Supplier Qualification Form

The main purpose of the supplier qualification form is to help fully understand the risk assessment of the supplier company and the company's capabilities. Every company that wants to do business with Loran must first fill out this form and wait to proceed to the next stage depending on the form evaluation result. Loran supplier qualification form is open to all visitors through Loran's online platforms (https://loranaero.com/supqualification-section1.html). All data is stored and evaluated on the ERP system.

Purchasing Exception

If the product is not available from another company in the market, or the product is "hard to find", or the customer has a special supplier request for the product, Loran carries out the product order subject to the approval of the Senior Management, except for the supplier being an "approved" supplier. These suppliers are classified as "Conditionally Approved" suppliers for Loran. If traceability is unavailable, or the documentation is suspected of being falsified, Loran discontinues efforts to procure the part.

Traceability

The traceability term is a capability to track and document the history, location and (if exist) usage of the product or the materials from the manufacturing stage to (if exist) the distributors/suppliers and to the current end-user.

Certificate of Conformity (CoC/CofC)

It is also known as a Certificate of Compliance or Certificate of Conformance, is a document that verifies that a product or service meets required standards or specifications. The document may include information such as manufacturer, distributor, quantity, lot and/or date code, inspection date, etc., and is signed by a responsible party for the supplier. Loran carries out its policy covering the preparation, preservation and transmission of CoC documents to the customer in accordance with the AS9163 2022-12 Standard.

Certificate of Origin (CoO)

It is an origin country declaration for supplied product.

Materiel

In our QMS, refers to material, parts, assemblies, and other procured items (except for electronic and chemical parts).

Manufacturer

In our QMS, refers to the point of origin of any materiel covered by the standard, including factories, mills, foundries, mines, chemical plants, laboratories, etc.

Suspect Materiel: Materiel, items, or products in which there is an indication by visual inspection, testing, or other information that it may meet the definition of fraudulent materiel or counterfeit materiel provided below.

Fraudulent Materiel: Suspect materiel misrepresented to the customer as meeting the customer’s requirements.

Counterfeit Materiel: Fraudulent materiel that has been confirmed to be a copy, imitation or substitute that has been represented, identified, or marked as genuine, and/or altered by a source without legal right with intent to mislead, deceive or defraud.

Identity

Information such as the current design authority, original manufacturer, trademark or other intellectual property, performance, unique item identifier, part number, date code, lot number, testing methods and results, inspection, documentation, warranty, origin, ownership history, packaging, storage, handling, physical condition, previous use, etc.

Authentic

Produced with legal right or authority granted by the legally authorized source.

Aftermarket Manufacturer

A manufacturer that meets one or both of the following criteria:

• The manufacturer is authorized by the original manufacturer to produce and sell replacement materiel, usually due to an original manufacturer decision to discontinue production of materiel. Materiel supplied is produced from dies, molds, or other manufacturing equipment that has been:

• transferred from the original manufacturer to the aftermarket manufacturer,
• produced by the aftermarket manufacturer using original manufacturer tooling and intellectual property (IP), or
• produced by the aftermarket manufacturer through redesign to match the original manufacturer’s specifications without violating the original manufacturer’s intellectual property rights (IPR), patents, or copyrights.

• The manufacturer produces materiel by emulating or reverse-engineering obsolete materiel to satisfy continuing customer needs without violating the original manufacturer’s intellectual property rights, patents, or copyrights.

Approved Supplier

Suppliers that are formally assessed by the current design activity or the original manufacturer, determined to be a trusted source that will reliably provide authentic and conforming materiel, and entered on a register of approved suppliers.

Authorized Reseller

An entity who has a legally binding relationship with the legally authorized source but does not provide direct product support to the customer.

Authorized Supplier

Aftermarket manufacturers as defined above, and suppliers authorized by the current design activity or the original manufacturer to produce and/or sell materiel.

Certificate of Authenticity

A statement to the effect that all materiel items listed above furnished on this contract are genuine, new and unused unless otherwise specified in writing herein; are suitable for the intended purpose; are not defective, suspect, or counterfeit; have not been provided under false pretenses; and have not been materially altered, damaged, deteriorated, or degraded.

Disposition

Decisions made by authorized representatives within an organization concerning future treatment of nonconforming material. Examples of dispositions are to scrap, mutilation, use-as-is (normally accompanied by an approved variance/waiver), retest, rework, repair, or return-to-supplier.

Original Manufacturer

An organization that designs and/or engineers and produces material and is pursuing or has obtained the intellectual property rights to that material.

Notes: 

• The material and/or its packaging are typically identified with the original manufacturer’s trademark.
• Original manufacturers may contract out manufacturing and/or distribution of its product.
• Different original manufacturers may supply product for the same application or to a common specification.

Supply Chain Traceability

Documented evidence of materiel’s supply chain history. This refers to documentation of all supply chain intermediaries and significant handling transactions, such as from original manufacturer to distributor, or from excess inventory to broker to distributor.

Heat Number

The heat number is used to trace the material's origin to ensure metal quality. It's similar to a batch number as it relates to quality control in manufacturing facilities. This number should match the number that is printed or stamped on the surface of the material.

Uncertainty

Lack of understanding of an event or its knowledge, outcome or probability. It should not be confused with measurement uncertainty.

Risk

Negative impact of uncertainty

Opportunity

The positive effect of uncertainty

Controlled Document

All documents reviewed and approved before they are published for use or reference.

UN-Controlled Document:

All documents or forms which are need to approval before the use.

Interested Party

The companies who buy the products from Loran, or the companies who supply the products to Loran, or any parties which have in a relationship with Loran Aerospace.

Foreign Object Damage (FOD)

All kinds of non-process tools, consumables, equipment, product protective devices, personal items, product process wastes, operational wastes, environmental residues are considered as foreign objects as Damage Objects.

Configuration

It is a documented information covers the technical and physical specifications of the product. This documented specs are open for the distributors and customers, to avoid any fault or mis-ordering process.

Configuration Management

It is a discipline to keep, manage and reports the records, technical and physical revisions for a product in its lifecycle.

Calibration

Calibration is the process of configuring an instrument to provide a result for a sample within an acceptable range.