Quality management system version 12 AAL Process Map AAL has identified its processes as per below...

Quality Management System Version 1.0

December 2018

AAL-QMS v1: 12-2018

Property of Accreate Additive Labs and published at www.accreatelabs.com/info. If printed, this document is uncontrolled and for reference only.

Accreate Additive Labs 31 December 2018 Page 2 of 37

QUALITY MANAGEMENT SYSTEM VERSION 1.0

COPYRIGHT STATEMENT

This QUALITY MANAGEMENT SYSTEM is the property of Accreate Additive Labs and intended for exclusive use by employees in the furtherance of a recognizable quality standard. All items contained within this document are STRICTLY CONFIDENTIAL. Contents of this document are made available to AAL’s customers, certification bodies and other interested parties only with the Company’s permission. This manual in part or whole should not be disclosed to third party without prior written authorization from Accreate Additive Labs.

AUTHORIZATION

Name Title Signature Date

Mr. S. Satish Director – Aerospace

Quality Assurance Manager

and Management

Representative

Mr. Ravi Shankar S N Managing Director

CHANGE CONTROL

Version Date Summary of Changes Author

1.0 31-Dec 2018 Initial Document Mr. Ravi Seshadri

1.1 08-Mar 2019 With updates Mr. Ravi Seshadri

http://www.accreatelabs.com/info




Table of Contents

1 Quality Management System ................................................................................................................ 5

1.1 AAL Organization and the Context ............................................................................................... 5

1.2 Interested Parties .......................................................................................................................... 5

1.3 Scope of AAL-QMS ....................................................................................................................... 6

1.4 AAL Quality Management System ................................................................................................ 6

1.5 Quality Organization ...................................................................................................................... 7

2 AAL Process Map ................................................................................................................................. 8

2.1 Customer-oriented Processes (Core Processes) ......................................................................... 8

2.2 Management Processes ............................................................................................................... 8

2.3 Supporting Processes ................................................................................................................... 9

3 Customer-oriented Processes ............................................................................................................. 10

3.1 Market Analysis and New Product Planning ............................................................................... 10

3.2 Sales and Customer Relationship Management ......................................................................... 11

3.3 Product Design, Development .................................................................................................... 12

3.4 Production ................................................................................................................................... 14

3.5 Delivery and after-Sales Support ................................................................................................ 20

3.6 Product Configuration Management ........................................................................................... 21

4 Management Processes ..................................................................................................................... 22

4.1 Calibration and Standards ........................................................................................................... 22

4.2 Change Management .................................................................................................................. 23

4.3 Documentation and Control Management .................................................................................. 24

4.4 Risk management ....................................................................................................................... 25

4.5 Resource management ............................................................................................................... 26

4.6 Information management ............................................................................................................ 28

4.7 Management Review .................................................................................................................. 29

5 Supporting Processes ......................................................................................................................... 30

5.1 Procurement ................................................................................................................................ 30

5.2 Inventory management ............................................................................................................... 32

5.3 Internal Audit ............................................................................................................................... 33





5.4 Training and Development .......................................................................................................... 34

5.5 Corrective Actions ....................................................................................................................... 35

5.6 Environment, Regulatory Compliance ........................................................................................ 36

6 Appendix - A ........................................................................................................................................ 37

6.1 Process Monitoring and Control - templates ............................................................................... 37

7 Appendix - B ........................................................................................................................................ 37

7.1 Calibration Intervals .................................................................................................................... 37





1 Quality Management System

1.1 AAL Organization and the Context Accreate Additive Labs Private Limited (AAL) is at the forefront of professional engineering services for

rapid adoption of 3D printing technology. Accreate Labs offers design enabling services, end to end design

enhancement to print services. Our suite of best in class software, pre-processing capabilities, wide range

of print capabilities covers plastics, polymers and metals. AAL is also to extend the 3D printing to various

other materials types than those stated. The state-of-the-art contemporary post processing center makes

a huge difference in producing superior outcomes for our clients. Accreate Labs would be one of a kind lab

in the country, applying 3D printing capabilities for focused sectors such as Aerospace, Defense and

Healthcare.

The products manufactured and fabricated at Accreate Additive Labs (AAL) shall be realized and tested as

per approved procedures commensurate with high quality, reliability meeting the customer requirements.

This document provides the quality assurance requirements to be complied with the specified

requirements.

The document specifies the complete details on development and qualification, manufacturing and testing

that are to be carried out at the premises of AAL. The design assurance aspects are not detailed in the

document, however, the document deliverables as part of design assurance are included.

1.1.1 Policy Statement “We the entire team at Accreate Additive Labs, shall realize the company’s vision of becoming a trusted service-provider of choice to our clients by committing to achieve customer satisfaction by delivering to requirements and on-time, every time.” The quality program at AAL is developed to assure customer satisfaction by providing quality products. AAL

will perform all activities in a manner, which meets or exceeds the expectations of our customers.

AAL shall utilize the expertise and accumulated experience of every team-member to achieve "zero-

defects" in development, design, services, realization and manufacture of products; and remain committed

to continuous improvement.

1.2 Interested Parties

1.2.1 Definition Interested Party is defined as a “stakeholder” – a person or an organization that can affect, be affected by,

or perceive to be affected by an activity or decision of AAL.

1.2.2 Criteria The criteria used to determine interested parties for AAL, are relevance of their activity, their requirements

and expectations from AAL, pertaining to AAL’s areas of operation viz. design and production of 3D-printed

parts for application in aerospace and other sectors.

For the Quality Management System at AAL, the Interested parties that are relevant are our:

• Customers – e.g. OEMs and their tiered suppliers

• Suppliers of input materials– e.g. Altem Technologies

• Strategic Partners – e.g. Stratasys, Materialise, Dassault Systemes

• Regulatory authorities – e.g. CEMILAC, DGCA, ISRO





• Certifying agencies – e.g. NQA

• Employees

• Shareholders

1.2.3 Voice of Interested Party • AAL shall monitor and review data periodically about interested parties and their relevant

requirements.

• This review shall be conducted for each interested party identified as per the above definition and

criteria, once a year or as required to effectively understand to meet their interests proactively.

1.3 Scope of AAL-QMS

1.3.1 Description Accreate Additive Lab's Quality Management System, or AAL-QMS lays down the policies and processes:

• to direct and govern all activities of AAL including sales and customer relations, design for 3D-

priting (Additive Manufacturing), production by Additive Manufacturing and related technologies,

procurement, testing for compliance, shipment, and activities managing and supporting the above

• to effectively meet the AS9100-D Standard’s requirements that are relevant for activities of AAL

• and to meet the expectations of AAL’s interested parties effectively and consistently

1.3.2 Scope Document • The scope of AAL-QMS shall be available for reference on the company’s website:

www.accreatelabs.com/info, and maintained as documented information.

1.3.3 Non-applicable Clauses of Standard The Scope of AAL-QMS currently includes all Clauses of AS9100-D Standard as relevant to the activities

of AAL described in 1.3.1 above. If AAL determines that any requirement of this Standard as not applicable

to the scope of its quality management system, the same shall be stated here with appropriate justification.

1.3.4 Revision Revision to the Scope shall be governed by the Documentation and Control Process [AAL-QMS 4.3].

1.4 AAL Quality Management System The processes designed to meet and exceed our customer requirements consistently and aligned to our

organization’s purpose and strategic direction is documented here as our Quality Management System. It

includes goals and aspirations of the company, policies, processes, documented information and

resources needed to implement and maintain it.

AAL have implemented, and shall strive to continually improve the quality management system, including

processes needed and their interactions, in accordance with the requirements of AS9100-2016 D. Our QMS

also addresses customer and applicable regulatory and statutory quality management system

requirements.

AAL has identified the processes needed for the quality management system and their application

throughout the organization, and has:

• identified the inputs required and the outputs expected from these processes;

• identified the sequence and interaction of these processes;

• identified and applied the criteria and methods (including monitoring,measurements, related

performance indicators) needed to ensure theeffective operation and control of these processes;

• identified the resources needed for these processes and ensure their availability;






• assigned the responsibilities and authorities for these processes;

• addressed the risks and opportunities

• evaluated these processes and implemented any changes needed to ensure that these

processes achieve their intended results;

• improve the processes and the quality management system.

To the extent necessary, AAL shall also:

• maintain documented information to support the operation of its processes;

• retain documented information to have confidence that processes are executed as planned.

The policies, procedures and documentation described in this QMS are mandatory and binding on all the

employees of AAL.

1.4.1 QMS Review, Revision QMS shall be reviewed as required, with at least two revisions a year. Revisions shall be governed by the

Documentation and Control Process [AAL-QMS 4.3]. Management reviews of QMS are aimed at ensuring

r indicated with the QMS or its implementation shall be addressed on priority and corrected as directed by

the Management.

1.4.2 Documentation The QMS documented here may be supported by work instructions aimed at improving the performance

or control of an activity/process. Work instructions affecting Quality shall be duly approved by the

Management Representative.

1.5 Quality Organization

1.5.1 Management Representative The Management Representative reports directly to the CEO of AAL. He is the delegated authority and has

organizational freedom to identify quality issues, evaluate options, recommend and implement solutions.

1.5.2 Responsibilities of the MR The Management Representative is responsible for:

• Create, update and distribution control of the Quality Manual as required.

• Planning to meet customer's quality requirements.

• Determining inspection points within the system.

• Approval of quality work instructions.





• Directing inspection activities.

• Surveillance of procurement documents.

• Approval of Suppliers, Maintaining a listing of approved suppliers.

• Monitoring procedures to assure compliance

• Reviewing and maintaining Quality Records.

• Calibration of Measuring and Test Equipment.

• Approval of disposition of Nonconforming Articles

• Corrective action coordination

The Management Representative shall be supported with necessary manpower, and infrastructure as

required by the management.

2 AAL Process Map AAL has identified its processes as per below and determined the sequence and interactions of the

processes using the Turtle diagram as tool. Sequence is illustrated with connected turtles where the output

from one turtle is the input to the next.

2.1 Customer-oriented Processes (Core Processes) • Market Analysis and Product Planning

• Sales and Customer Relations Management

• Product Design, Development

• Production

• Delivery and after-Sales Support

• Product Configuration Management

2.2 Management Processes • Calibration and Standards

• Change Management

MATERIAL: Thermoplastic, thermosetting resins, support material EQUIPMENT: Fortus 450, Connex 500, Water wash post processing SOFTWARE: Dassault 3D Experience, Materialise Mimics

PROCESS OWNER: Production

Engineer

SKILLS: Designing and Modelling,

Print Development

COMPETENCY: Expert certified by

Stratasys, Dassault respectively

SUPPORT STAFF:

Sales/CRM Executive

Procurement Executive

Quality/MR

Inventory/Stores Manager

Maintenance Engineer

INPUT: CUSTOMER REQUIREMENTS Design specifications, material

requirements, dimension, functional

characteristics, statutory or regulatory

requirements

OUTPUT: Criteria for

requirements met Y/N:

Dimensional check,

Functional testing

SUPPORT PROCESSES:

Human Resources,

Quality, Inventory,

Procurement,

Customer Relationship

MEASUREMENT:

Production Analysis,

Quality, Efficiency vs.

Effectiveness,

Profitability

HOW is PROCESS CONTROLLED: PROCEDURE CONTROL DOC

TIMING CHARTS

WORK INSTRUCTIONS

Production

process





• Documentation and Control Management

• Quality Assurance, Risk management

• Resource management

• Information management

• Management Review

2.3 Supporting Processes • Procurement

• Inventory Management

• Internal Audit

• Training and Development

• Corrective Actions

• Environmental, Regulatory Compliance





3 Customer-oriented Processes

3.1 Market Analysis and New Product Planning

AAL shall conduct periodic research of the target markets to understand emerging scenario in technology,

customer requirements and innovation, including the size and potential value of the opportunities to all

interested parties of AAL. For this AAL shall use a process-based approach as illustrated above.

A. Market Research: AAL shall conduct a scientific market research as often as deemed necessary,

and at least once every two years, with the objective of determining emerging market opportunities

for AAL in additive manufacturing and related domains, for applications in aerospace.

B. Understand Requirements: Typical requirements of potential customers are collected and

analyzed for AAL’s ability to serve them. Requirements shall include environmental, regulatory and

any other special requirements that could be relevant.

C. Demand Estimation: AAL shall use scientific methods to estimate the market size and

addressable market opportunity for AAL in a reasonable timeframe.

D. Opportunity Evaluation: AAL Management reviews the demand estimation to determine if the

opportunity is attractive. Risks associated with this opportunity are also analyzed together with the

demand estimation.

E. Capability Check: If AAL Management finds the opportunity as worth exploring it reviews AAL’s

ability to service the opportunity, to determine the required investments in Resources and Training.

F. Product Feasibility: AAL shall determine the product that can be designed and developed within

its available capabilities and resources. Management reviews the “feasible product” and analyzes

the gaps between it and the “ideal product” determined from Market Research. Management

decides whether to go ahead with the “feasible product” or put it off till further capabilities and

resources are made available.





G. Product Design – Alpha, Beta: Once AAL decides to design, develop and produce the New

Product, AAL Management assigns key resources to create a project plan and implement it. Initial

product design is created based on the identified requirements in AAL-QMS 3.1.A. Customer

feedback is sought on the Alpha Design, and further improvements are implemented to create the

Beta Design. This is again validated against customer feedback.

H. Demand Planning: AAL Management shall estimate the potential demand by month and quarter,

based on feedback from potential customer and market analysis.

I. Design Freeze: Beta design is improved to meet customer requirements. After validation with

customer the Design is finalized and documented as ‘frozen’. Subsequent changes to Design are

governed by the Change Management Process [AAL-QMS 4.2]. Production Design shall use

Additive Manufacturing as the primary production technology.

J. Production Planning: Detailed Production Design for Additive Manufacturing shall be developed.

This shall include the selected technology for Additive Manufacturing, the equipment to be used,

the model material and support material for 3D-printing, and any post-processing process to be

adopted. AAL may also identify risks and contingent actions as necessary for superior quality

production.

3.2 Sales and Customer Relationship Management

AAL is committed to building and nurturing close relationships with customers to create mutual lasting value.

For this AAL shall follow a process-based approach for end-to-end customer engagement.

A. Understand Requirements: Requirements received from customer are reviewed by AAL’s multi-

functional team comprising Design, Procurement, Inventory, Production, Shipment and the

Management. Relevant requirements for environmental, regulatory compliance are examined and

included. Management reviews AAL’s ability to meet and exceed requirements, including





availability of Resources e.g. skilled people, infrastructure and equipment, input materials. AAL

advises customer on whether it can meet requirements and estimated time to submit proposal.

B. Documentation: AAL’s understanding of the requirements is validated with customer and

documented.

C. Proposal: The customer-validated requirements understanding is input to Sales team for creating

the Proposal Document. The Opportunity owner within the Sales team prepares the Proposal with

inputs from the multi-functional team on input cost, design and production cost, turn around time,

and any risks as applicable. Procurement, Packaging, Delivery and after-sales services. As

relevant, procurement may work with supplier to secure availability of input material and allow

enough time for inward quality check and receive into inventory. (Not clear may be simplified)

Sales team gets proposal approved by Management and submits to customer. If customer

demands for changes to the Proposal, Management reviews the demands and decides if a revised

proposal should be submitted. If yes, the Sales team prepares the revised proposal with inputs

from the multi-functional team. Any last-minute changes accepted are reviewed by AAL

Management.

D. Contract: Once customer accepts the proposal, a contract is prepared and signed by AAL with

customer’s authorized representative. The contract lists responsibilities of either party, scope of

the work, commercials and the detailed customer requirements as documented from the validated

requirements understanding [AAL-QMS 3.2 B].

E. Contract Review: Signed contract is reviewed by a multi-functional AAL team and relevant AAL

teams are apprised on their tasks: requirements to meet within the associated constraints.

3.3 Product Design, Development





3.3.1 Requirements for Design of Products and Services

3.3.1.1 Customer Communication AAL shall ensure that communication with customers include:

a) Providing complete and accurate information relating to products and services capabilities

b) Responding to enquiries with approved proposals, to change requests on contracts

c) Clarifying on customer requirements including those of environmental and regulatory compliance

d) Obtaining feedback relating to products and services, including complaints

e) Controlling customer property

f) Recording requirements for contingency actions when relevant.

3.3.1.2 Determining the Requirements for Design of Products and Services Design by AAL is limited in scope to provision of Design for Additive Manufacturing (DFAM). The

engineering design is either provided as input by the customer or sourced by AAL from a Design Partner.

AAL shall provide the design for production by Additive Manufacturing technology.

AAL shall ensure that:

a) the Requirements for DFAM are defined clearly and comprehensively, including:

1) any applicable statutory and regulatory requirements

2) those considered necessary by customer or AAL

b) special requirements of the products and services are determined

c) operational risks (e.g. new technology, ability and capability to provide, short delivery time frame)

are identified and managed appropriately.

3.3.1.3 Review of the requirements for Design of products and services Requirements Review shall be coordinated with the applicable functions of AAL, to evaluate if the claims

made by AAL for the products and services it offers are met consistently and entirely. If upon review AAL

finds that some customer requirements cannot be met or can only be partially met, AAL shall negotiate a

mutually acceptable requirement with our customer.

AAL shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer requirements shall be confirmed by AAL before acceptance, if customer does not provide a

documented statement of their requirements. In situations where formal requirements review is impractical

for each order, the review shall cover relevant product information in marketing collateral e.g. brochures.

AAL shall retain documented information as applicable:

a) On the results of the review;

b) On any new requirements for products and services.

3.3.1.4 Changes to Requirements for Design of Products and Services AAL shall ensure that relevant documented information is amended, and that relevant persons are made

aware of the changed requirements, when the requirements for Design for Additive Manufacturing are

changed.

3.3.2 Configuration Management Configuration Management in Design shall follow the process detailed in AAL-QMS 3.6.

3.3.3 Product Safety AAL shall ensure that measures for product safety are included right at the Design stage. AAL shall prepare

a Safety Management Plan which includes:





a) Identification of equipments/items/materials which require special safety precautions

b) Assessment of hazards and management of associated risks

c) Management of safety critical items

d) Analysis and reporting of occurred events affecting safety

e) Communication of these events and training of persons.

3.4 Production

3.4.1 Requirements for Production of Products and Services

3.4.1.1 Customer Communication AAL shall ensure that communication with customers include:

a) Providing complete and accurate information relating to products and services capabilities

b) Responding to enquiries with approved proposals, to change requests on contracts

c) Clarifying on customer requirements including those of environmental and regulatory compliance

d) Obtaining feedback relating to products and services, including complaints

e) Controlling customer property

f) Recording requirements for contingency actions when relevant.

3.4.1.2 Determining the Requirements for Production AAL shall ensure that

a) the requirements for the products and services are defined, including:

1) any applicable statutory and regulatory requirements;

2) those considered necessary by the organization;

b) special requirements of the products and services are determined;

c) operational risks (e.g. new technology, ability and capability to provide, short delivery time frame)

are identified and managed appropriately.





3.4.1.3 Review of the requirements for Production Requirements Review shall be coordinated with the applicable functions of AAL, to evaluate if the claims

made by AAL for the products and services it offers are met consistently and entirely. If upon review AAL

determines that some customer requirements cannot be met or can only be partially met, AAL shall

negotiate a mutually acceptable requirement with the customer.

AAL shall ensure that contract or order requirements differing from those previously defined are resolved

suitably. The customer requirements shall be confirmed by AAL before acceptance, if customer does not

provide a documented statement of their requirements. In situations where formal requirements review is

impractical for each order, the review shall cover relevant product information in marketing collateral e.g.

brochures.

AAL shall retain documented information as applicable:

a) On the results of the review;

b) On any new requirements for products and services.

3.4.1.4 Changes to Requirements for Production AAL shall ensure that relevant documented information is amended, and that relevant persons are made

aware of the changed requirements, when the requirements for production are changed.

3.4.2 Configuration Management Configuration Management in Production is an important activity recognized by AAL and shall follow the

process detailed in AAL-QMS 3.6.

3.4.3 Production planning and control AAL shall plan, implement, and control the processes needed to meet the requirements for the provision

of products and services, and to implement the actions, by;

a) determining the requirements for the products and services;

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

c) determining the resources needed to achieve conformity to the product and service requirements;

d) implementing control of the processes in accordance with the criteria;

e) determining, maintaining and retaining documented information to the extent necessary:

1) to have confidence that the processes have been carried out as planned;

2) to demonstrate the conformity of products and services to their requirements

f) Determining the processes and controls needed to manage critical items, including production

process controls when key characteristics have been identified;

g) Engaging representatives of affected organization functions for operational planning and control;

h) Determining the process and services to be obtained from external providers;

i) Establishing the controls needed to prevent the delivery of non-conforming products and services

to the customer.

AAL shall plan and manage product and service provision in a structured and controlled manner including

scheduled events performed in a planned sequence to meet requirements at acceptable risk, within

resource and schedule constraints.





The output of this planning shall be suitable for AAL’s operations. As an output of this planning, documented

information specifying the processes of the quality management system and the resources to be applied to

a specific product, service project, or contract can be referred to a quality plan

AAL shall control planned changes and review consequences of unintended changes, taking measures to

mitigate any adverse effects, as necessary. AAL shall establish, implement and maintain a process to plan

and control the temporary or permanent transfer of work, to ensure the continuing conformity of the work

to requirements. The process ensures that work transfer impacts and risks are managed.

3.4.4 Production and Service Provision

3.4.4.1 Control of Production and Service Provision AAL shall implement production and service provision under controlled conditions. Controlled conditions

shall include, as applicable;

a) Availability of documented information that defines;

1) The characteristics of the product to be produced, the services to be provided, or the

activities to be performed;

2) The results to be achieved, (e.g., digit definition data, drawings, parts lists, materials,

process specifications, process flow charts, control plans, production documents and

verification documents).

b) Availability and use of suitable monitoring and measuring resources;

c) Implementation of monitoring and measuring activities at appropriate stages to verify that criteria

for control of processes or outputs, and acceptance criteria for products and services, have been

met:

1) Ensuring the documented information for monitoring and measurement activity for product

acceptance includes:

i. Criteria for acceptance and rejection;

ii. Where in the sequence verification operations are to be performed;

iii. Measurement results to be retained (at a minimum an indication of acceptance or

rejection)

iv. Any specific monitoring/measurement equipment required, and instructions associated

with their use:

2) Ensuring that when sampling is used as a means of product acceptance, the sampling plan

is justified based on recognized statistical principles and appropriate for use (e.g., matching

the sampling plan to the criticality of the product and to the process capability).

d) Use of suitable infrastructure and environment for the operation of processes; (infrastructure can

include product specific tools such as jigs, fixtures, moulds and software programs.)

e) Appointment of competent persons, including any required qualification;

f) Validation, and periodic revalidation, of the ability to achieve planned results of the processes for

production and service provision, where the resulting output cannot be verified by subsequent

monitoring or measurement; (These can be referred to as special processes, see 8.5.1.2)

g) Implementation of actions to prevent possible human error;

h) Implementation of releases, delivery, and post-delivery activities;

i) Criteria for workmanship (e.g., written standards, representative sample, illustrations);

j) Accountability for all products during production (e.g., parts quantities, split orders, nonconforming

product);

k) The control and monitoring of identified critical items, including key characteristics, in accordance

with established processes;

l) The determination of methods to measure variable data(e.g., tooling, on-machine probing,

inspection equipment);

m) The identification of in-process inspection/verification points when adequate verification of

conformity cannot be performed at later stages;





n) The availability of evidence that all production and inspection/verification operations have been

completed as planned or as otherwise documented and authorized;

o) The provision for the prevention, detection, and removal of foreign objects;

p) The control and monitoring of utilities and supplies (e.g., water, compressed air, electricity,

chemical products) to the extent they affect conformity to product requirement (see 7.1.3)

q) The identification and recording of products released for subsequent production use pending

completion of all required measuring and monitoring activities, to allow recall and replacement if it

is later to be found that the product does not meet requirements.

3.4.4.2 Control of Equipment, Tools, and Software Programs Equipment, tools, and software programs used to automate, control, monitor, or measure production

processes shall be validated prior to final release for production and shall be maintained.CEO shall have

the authority to approve changes to production processes.

To ensure product conformity, AAL shall validate production processes, equipment, tools, setup and

software programs prior to production or after changes have been made through first piece inspection

during each operation.

Production equipment shall be maintained in accordance with established preventive maintenance plans

“Preventive Maintenance Process” and shall be logged.

Storage requirements are to be defined for production equipment or tooling in storage including any

necessary periodic preservation or condition checks.

3.4.5 Control of Externally Provided Processes, Products, and Services

3.4.5.1 General AAL shall ensure that externally provided processes, products, and services conform to requirements

AAL is responsible for the conformity of all externally provided processes, products and services, including

from sources defined by the customer. However, AAL does (does not) accept responsibility for the

conformity of Products or Material provided by the customer. (e.g.,3D printed part from customer for post)

AAL shall ensure that, when required, that customer-designated or approved external providers, including

process sources (e.g. special processes) are used.

AAL shall identify and manage the risks associated with the external provision of processes, products, and

services, as well as the selection and use of external providers.

AAL requires that external providers apply appropriate controls to their direct and sub-tier/external

providers, to ensure that requirements are met.

AAL determines the controls to be applied to externally provided processes, products and services when:

a) products and services from external providers are intended for incorporation into our products and

services

a)

b) products and services are provided directly to the customer(s) by external providers on behalf of

AAL

c) a process, or part of a process, is provided by an external provider as a result of a decision by AAL

AAL shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-

evaluation of external providers, based on their ability to provide processes or products and services in

accordance with requirements. AAL retains documented information of these activities and any necessary





actions arising from the evaluations. Supplier selection and evaluation is defined in AAL-XXXX-XX

Purchasing Process Supplier Evaluation.

3.4.5.2 AAL has the authority to: a) define the process, responsibilities, and authorize the approval status

b) making decision, changes of the approval status, and conditions for a controlled use of external

providers depending on their approval status;

c) maintain a register of the external providers that includes approval status, (e.g. approved,

conditional, disapproved) and the scope of the approval (e.g. product type, process family);

d) periodically review external provider performance including process, product and service

conformity, and on time delivery performance;

e) define the necessary actions to take when dealing with external providers that do not meet

requirements;

f) define the requirements for controlling documented information created and/or retained by external

providers.

3.4.6 Type and Extent of Control AAL ensures that externally provided processes, products and services do not adversely affect our ability

to consistently deliver conforming products and services to its customers. AAL:

a) ensures that externally provided processes remain within the control of its quality management

system;

b) defines both the controls that it intends to apply to an external provider and those it intends to apply

to the resulting output;

c) takes into consideration:

1) the potential impact of the externally provided processes, products and services on the

organization’s ability to consistently meet customer and applicable statutory and regulatory

requirements;

2) the effectiveness of the controls applied by the external provider;

3) the results of the periodic review of external provider performance;

d) determines the verification, or other activities, necessary to ensure that the externally provided

processes, products and services meet requirements.

Verification activities of externally provided processes, products, and services shall be performed according

to the risks identified by AAL These include inspection or periodic testing, as applicable, when there is a

high risk of non-conformities including counterfeit parts.

When externally provided product is released for production use, pending completion of all required

verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently

found that the product does not meet requirements.

When AAL delegates verification activities to the external provider, the scope and requirements for

delegation will be defined and a register of delegations is maintained. We periodically monitor the external

provider’s delegated verification activities.

3.4.7 Information for external providers AAL ensures the adequacy of requirements prior to their communication to the external provider.

AAL shall communicate to external providers its requirements for:

a) the processes, products and services to be provided, including the identification of relevant

technical data (e.g. specifications, drawings, process requirements, work instructions);





b) the approval of:

1) products and services;

2) methods, processes and equipment;

3) the release of products and services;

c) competence, including any required qualification of personnel;

d) the external providers’ interactions with the organization;

e) control and monitoring of the external providers’ performance to be applied by the organization;

f) verification or validation activities that the organization, or its customer, intends to perform at the

external providers’ premises.

g) design and development control (if any)

h) Special requirements, critical items, or key characteristics;

i) Test, inspection, and verification (including production process verification);

j) The use of statistical techniques for product acceptance and related instructions for acceptance by

the organization

k) The need to:

− Implement a quality management system;

− Use customer-designated or approved external providers, including process sources (e.g. special

processes);

− Notify the organization of non-conforming processes, products, or services

and obtain approval for their disposition;

− Prevent the use of counterfeit parts;

− Notify the organization of changes to process, products, or services, including changes to their

external providers or location of manufacture, and obtain the organization’s approval;

− Flow down to external providers applicable requirements including customer requirements

− Provide test specimens for design approval, inspection/verification, investigation, or auditing;

− Retain documented information, including retention periods and disposition requirements;

l) The right of access by the organization, their customer, and regulatory authorities to the applicable

areas of facilities and to applicable documented information, at any level of the supply chain

m) Ensuring personnel are aware of:

− Their contribution to product or service conformity;

− Their contribution to product safety

− The importance of ethical behavior

3.4.8 Prevention of Counterfeit Parts AAL shall plan, implement and control processes, appropriate to the organization and the product for the

prevention of counterfeit or suspected counterfeit part use and their inclusion in product(s) delivered to the

customer.

Counterfeit part prevention processes should consider:

a) Training of appropriate persons in the awareness and prevention of counterfeit parts;

b) Application of a part obsolescence monitoring program

c) Controls for acquiring externally provided product from original or authorized manufacturers,

authorized distributors, or other approved sources;

d) Requirements for assuring traceability of parts and components to their original authorized

manufacturers

e) Verification and test methodologies to detect counterfeit parts;

f) Monitoring of counterfeit parts reporting from external sources

g) Quarantine and reporting of suspect or detected counterfeit parts.





3.4.9 Non-conformance control

3.4.10 Corrective Action Procedures Conditions adverse to quality shall be promptly identified and corrected. The root cause of the adverse

condition shall be determined, and action taken to correct and avoid repetition.

3.4.10.1 Customer Complaints Responses to Customer complaints shall be recorded by letter or on specified forms required by the

customer. Responses shallinclude cause of the condition, actions taken to prevent a future occurrence and

effective date.

3.4.11 Disposal All nonconforming articles are reviewed to determine disposal; the disposal is duly recorded .

3.4.11.1 Approval of Dispositions The Quality Manager approves all disposals of nonconforming articles as follows:

• Return to Supplier

• Rework to Specification

• Scrap

Customer approval of the following disposals shall be requested and required prior to delivery of articles:

• Use as Is (waiver)

• Repair to a Useable Condition

3.4.12 Reworked and repaired items Reworked and repaired items are re-inspected and/or tested in accordance with disposition instructions.

3.5 Delivery and After-Sales Support





A. Packaging and Shipment: Delivery to customer shall be done with due consideration for the

environmental, regulatory and logistics-related issues that may be relevant. AAL shall take

appropriate measures to ensure risks in shipment and delivery are mitigated through appropriate

packaging and choice of logistics partner.

B. Post-delivery requirements: Requirements of customer, environmental and regulatory agencies

regarding activities after the delivery are analyzed and documented.

C. In-service data from customer: Service or product delivered by AAL to customer is monitored as

applicable, through data provided by customer. This is used to design and deliver after-sales

support and services to customer.

D. Documents Control: Technical documents are updated and controlled to reflect the after-sales

requirements and related activities delivered in meeting those requirements.

E. Outsourced Activities: Activities related to after-sales if outsourced and delivered to customer

through a Supplier/Partner of AAL shall be managed, and their activities controlled, to ensure

appropriate service quality is rendered to customer.

3.6 Product Configuration Management

3.6.1 Configuration Management AAL shall plan, implement and control a process for configuration management as appropriate to the

organization and its products and services in order to ensure the identification and control of physical and

functional attributes throughout the products lifecycle.

This process shall:

a) control product identity and traceability to requirements including implementing identified changes





b) ensure that the documented information (e.g., requirements, design, verification, validation and

acceptance documentation) is consistent with the actual attributes of the products and services.

4 Management Processes

4.1 Calibration and Standards

4.1.1 Control of Measuring and Test Equipment

4.1.1.1 Commercial Equipment Calibration of normal commercial equipment (i.e., rulers, tape, measures, levels, and other similar devices)

is not required. It is the responsibility of the user to report worn or damaged equipment to management to

prevent inadvertent use.

4.1.1.2 Special Devices Calibration will be performed and maintained at prescribed intervals in accordance with Appendix B. An

external Calibration Laboratory duly certified is contracted to supply this service or by an internal calibration

engineer. The supplier is certified and performs calibrations traceable to recognized National Standards.

4.1.1.3 Identification of Equipment Each item is identified with current status of calibration with a Tag and the user is responsible to verify an

item is serviceable. Items too small to be identified are serialized, and calibration status is maintained by a

traceable record supporting a calibration recall system.





4.2 Change Management

A. Any requirement for a change is detected by respective functional areas and reported to

Management through a Change Request.

B. Management reviews the Change Request, and upon its approval the relevant sections of the

QMS and related work-instructions are updated e.g. to the Production Planning and Control.

These changes and revisions to processes are documented as per AAL-QMS 4.3.

C. The relevant functional areas implement the changes and report to Management.





4.3 Documentation and Control Management

4.3.1 Quality Records Quality records traceable to an article or a Lot will be stored by the identifying part number. Quality records

traceable to a Customer will be stored by the Customer's Order Number. The retention of Quality records

is a minimum of three years and later archived or as otherwise directed by a Customer Order Requirement.

4.3.2 Instructions and Drawings

4.3.2.1 Work Instructions Work instructions are utilized in support of this Quality Manual to improve the control of a specific operation

or evaluation, but in no circumstances shall these documents supersede or change the requirements of this

manual.

4.3.2.2 Drawings Drawings, specifications and/or catalog criteria shall be used to control the technical requirements of

products offered to our customers.

4.3.3 Document Control

4.3.3.1 Current Issues The latest issue of drawings, specifications, catalogs, work instructions and Customer orders will be utilized

to control articles throughout the operations system.

4.3.3.2 Modification or Design Changes Obsolete documents caused by modification or design change will be identified as such and removed from

use and suitablyarchived.





4.4 Risk management

4.4.1 Operational Risk Management AAL shall plan, implement, and control a process for managing operational risks to the achievement of

applicable requirements, which includes as appropriate to the organization and the products and services:

a) assignment of responsibilities for operational risk management;

b) definition of risk assessment criteria (e.g., likelihood, consequences, risk acceptance);

c) identification, assessment, and communication of risks throughout operations;

d) identification, implementation, and management of actions to mitigate risks that exceed the defined

risk acceptance criteria;

e) acceptance of risks remaining after implementation of mitigating actions.

Prior to acceptance of contract or purchase order, relevant risk criteria are assessed to identify risk and

determine feasibility. Criteria may include but are not limited to:

a) Engineering data (e.g., drawings, models, specifications, etc.) are made available,

b) Customer supplied quality requirements and/or vendor manual,

c) Configuration plan,

d) Quantity and delivery schedule,

e) Requirements for customer approved suppliers,

f) Lead time and cost for raw material and/or hardware items,

g) Lead time and cost for outside processing (e.g., heat treatment, plating, etc.),

h) Cost of any non-recurring charges, if any,

i) Labor hours and skill,

j) Equipment (e.g., tooling, fixtures, and resources),

k) Inspection and test plans

l) Any special requirements and expectations not stated in the request

If any of the above criteria cannot be resolved, or causes unease to trained personnel, then the order is

considered “high risk”.





On “high risk” orders:

• Top management investigates, confirms, and documents any risk associated with the order.

• Results of this assessment are logged on Internal Feasibility Review for 3D printing.

If the decision to accept risk is made, the appropriate personnel will be notified and the mitigation process

will continue.

4.5 Resource management

AAL shall determine and provide the resources needed for the establishment, implementation,

maintenance, and continual improvement of its QMS. The organization shall consider:

• the capabilities of, and constraints on, existing internal resources;

• what needs to be obtained from external providers

A. Personnel: AAL shall determine and provide the persons necessary for the effective

implementation of its quality management system and for the operation and control of its

processes.

B. Infrastructure: AAL shall determine, provide, maintain the infrastructure necessary for operating

its processes and to achieve conformity of products and services. Infrastructure may include:

• buildings and associated utilities;

• equipment, including hardware and software;

• transportation resources;

• information and communication technology

C. Environment for the Operation of Processes: AAL shall determine, provide, and maintain the

environment necessary for its processes and to achieve conformity of products and services.





D. Monitoring and Measuring Resources: AAL shall determine and provide the resources needed

to ensure valid and reliable results when monitoring or measuring is used to verify the conformity

of products and services to requirements. AAL shall ensure that the resources provided:

• are suitable for the specific type of monitoring and measurement activities being undertaken;

• are maintained to ensure their continuing fitness for their purpose.

AAL shall retain appropriate documented information as evidence of fitness for purpose of the

monitoring and measurement resources.

E. Measurement Traceability: AAL shall establish validity of its measurement results by:

• calibrating or verifying, or both, at specified intervals, or prior to use, against measurement

standards traceable to international or national measurement standards; when no such

standards exist, the basis used for calibration or verification shall be retained as documented

information;

• identifying the measuring instruments to determine their status;

• safeguarding from adjustments, damage, or deterioration that would invalidate the calibration

status and subsequent measurement results;

• AAL shall determine if the validity of previous measurement results has been adversely

affected when measuring equipment is found unfit for its intended purpose and shall take

appropriate corrective action.

F. Organizational Knowledge: AAL shall determine the knowledge necessary for the operation of its

processes and to achieve conformity of products and services. This knowledge shall be maintained

and be made available to the extent necessary. When addressing changing needs and trends, the

organization shall consider its current knowledge and determine how to acquire or access any

necessary additional knowledge and required updates.

NOTE 1: Organizational knowledge is knowledge specific to AAL; it is generally gained by

experience and is AAL’s intellectual property. It is information that is used and shared to achieve

the organization’s objectives.

NOTE 2: Organizational knowledge may be based on:

• internal sources (e.g., intellectual property; lessons learned from failures and successful

projects; capturing and sharing undocumented knowledge and experience; the results of

improvements in processes, products and services);

• external sources (e.g., standards; academia; conferences; gathering knowledge from

customers or external providers).





4.6 Information Management

AAL shall design and implement a process for managing and protecting its information.

A. AAL shall ensure that information created is documented and digitized at source as applicable, and

protected through appropriate technology and tools

B. This information includes Quality Standards accepted by AAL and the definition and measurement

criteria of performance metrics, performance measurement and management review information.

C. The system for managing information across AAL shall have consistency of data, currency (the

latest version is available to all users at any time), and easy accessibility.

D. Appropriate risk mitigation actions shall be taken by AAL to ensure redundancy, prevent loss or

theft of information, and leakage.

E. Protection of intellectual property such as organizational knowledge, patents and trademarks shall

be ensured through appropriate investments and implementation of information technology.





4.7 Management Review

A. AAL Management shall establish its goals for the long-term (3 years and beyond) and short-term

(immediate to 3 years). Management shall also define its strategy to realize these goals.

B. AAL Management shall periodically review the gaps in performance between the targets and

actual through inputs from internal audit, performance reviews; and identify corrective actions to

bridge the gaps.

C. Corrective Actions shall include Training and Development, upgrading skills and resources for

operations and planning, and improving execution of its processes and procedures.





5 Supporting Processes

5.1 Procurement

5.1.1 Procurement Documentation Control

5.1.1.1 System of Procurement Procurement documents are manually generated and include appropriate technical specifications and

quality requirements. When a customer has special requirements, such as a Certified Material Test Report,

the program is designed to include the requirement into the procurement documents of AAL.

5.1.1.2 Review and Approval Procurement documents are reviewed and approved by the Quality Manager in consultation with Purchase

Manager. The Quality Manager performs random surveillance of procurement documents bi-annually the

findings are documented.

5.1.1.3 Changes to Documents Changes to procurement documents are subject to the same level of control as in preparation of the original

document as mentioned in section 5.1.

5.1.2 Control of Purchased Items Purchase orders include statements in the “terms & conditions” section concerning the following items,

when and where AAL require these items:

a) Requirements for approval of product, procedures, processes and equipment,

b) Requirements for qualification of personnel,

c) Quality management system requirements,

d) Drawing and/or specifications (or other technical data) and applicable revision,

e) Requirements for design, test, examination, inspection, and related instructions for acceptance,

f) Requirements for test specimens, design approval, inspection/verification, investigation or auditing,





g) Supplier shall notify AAL of changes in product and/or process definition and, where required,

obtain organizational approval for nonconforming product disposition, requirements for the supplier

to flow down applicable requirements, (I feel this reads better)

h) Records retention requirements,

i) Right of access by the organization, their customer, and regulatory authorities to all facilities

involved in the order and to all applicable records, and

when any of these items are required by AAL, the required items are clearly stated on the first page of the

Purchase Order. AAL ensures adequacy of specified purchase requirements before communicating them

to the supplier.

When external provider test reports are utilized to verify externally provided products, AAL shall implement

a process to evaluate the data in the test reports to confirm that the product meets requirements. When a

customer or organization has identified raw material as a significant operational risk (e.g. critical items),

AAL shall implement a process to validate the accuracy of test reports. When applicable, AAL Quality will

review results.

5.1.2.1 Incoming Articles Receipt of purchased articles is documented on a Receiving Report (Appendix A). The requirements of the

Purchase Order are attached to the Receiving Report to provide the inspection function with complete

criteria for evaluation of the receipt.

5.1.2.2 Incoming Inspection Articles are inspected in accordance with the requirements of the receiving documents. As a minimum, all

articles shall undergo physical examination and inspected for count, identification performance and

damage.

5.1.2.3 Certifications Certifications and Certified Material Test Reports are reviewed for compliance and accuracy of contents as

required by procurement documents.

5.1.2.4 Rejected Articles Rejected articles will be documented as nonconforming items on the Receiving Report to prevent

inadvertent use or further processing. The Quality Manager will approve final disposition.

5.1.2.5 Acceptance Criterion Acceptance of the incoming materials will be documented on the Receiving Report as “ACCEPTED” and

the identity of the inspector will be included by initialing the document.

5.1.3 Inspection

5.1.3.1 Inspection of Stock Re-inspection of items will be conducted on specific articles in storage as a result of a customer complaint

or any suspected Quality problem concerning an article. Rejected articles will be identified or segregated

and disposed in accordance with control of nonconforming material. Accepted articles will be returned to

the stores.

5.1.3.2 Final Inspection Inspection of articles to be delivered to a customer will be accomplished prior to packaging for identification,

damage and in accordance with the shipping document. The customer ordered requirements are included

with the shipping document. Rejected articles will be identified or segregated and disposed in accordance

with control of nonconforming material. Accepted articles will be identified on the shipping document as

accepted by signature or initials.





5.1.3.3 Shipping Inspection Inspection of the packaging procedure will include evaluation to determine adequacy to preclude damage

during delivery and any special requirements directed by the customer mentioned in the order. Customer

requirements for Certifications and/or Certified Material Test Reports will be included with the articles.

5.1.4 Identification and Control of OEM Items The Original Equipment Manufacturer (OEM) articles will retain their identity through receipt, stocking and

delivery function traceable to the procurement and receipt documents containing acceptance status.

5.1.5 Customer Supplied Material Customer supplied material shall be marked and stored separately from other material.

5.2 Inventory management

A. Supplier’s material against AAL Procurement’s Purchase Orders are received and subjected to

inspection and testing per AAL-QMS 5.1.2 and 5.1.3

B. Prevention of counterfeit parts is ensured per AAL-QMS 3.4.8

C. Genuine material is tagged and taken into Inventory (Stores) as Goods Inward.

D. Production indents material from Stores as required, and Stores issues the material after updating

the Inventory logs.

E. Production Planning and Control team analyzes the procurement lead times and establishes

conformity of the material to requirements. It determines, maintains and retains documented

information to the extent necessary, to have confidence that the processes have been carried out

as planned. [As detailed in AAL-QMS 3.4.3]





F. Procurement function analyzes the Inventory logs for patterns in procurement and production

indents, to establish the optimal re-order quantities and frequency for Demand Planning.

Procurement is executed as per AAL-QMS 5.1.

5.3 Internal Audit

G. AAL Management shall periodically conduct internal audits of its processes against AS 9100 D

and other accepted AAL Standards for Quality.

H. AAL Management shall designate specific persons as Internal Auditors and provide them with

training and empowerment to audit all processes of AAL.

I. Internal Audit team shall develop a program and schedule for the audits and communicate the

same to all relevant personnel across the organization.

J. AAL Management shall implement the Internal Audits as scheduled and review the audit results.

K. Gaps in compliance are analyzed and Corrective Actions identified by AAL Management together

with the relevant functional teams, internal audit team and the Management Representative.

L. AAL Management shall assign representatives from relevant functional areas as implementation

owners of corrective actions and review their implementation.





5.4 Training and Development

A. AAL Management shall periodically review the skills, competence levels and awareness of the

QMS. These reviews include internal audits or other studies to identify training requirements to

meet upcoming goals of the organization.

B. AAL Management shall assign the HR function to identify skill and competence levels of workforce

required to meet organizational goals. With this information and input from reviews, Management

shall conduct Gap Analysis, with the HR function.

C. HR shall develop action plan to bridge the gaps through designing Skills Training, scheduling and

implementing it across the organization.

D. Workforce shall receive the training with enthusiasm and commitment, and demonstrate

improvement in skill, competence and QMS awareness.

E. HR shall develop and implement Career Development Roadmaps to address aspirations of

individuals who successfully meet the training goals, to prepare them for personal growth.

F. HR shall develop and implement Continuous Improvement program to prepare the organization for

meeting its future goals.





5.5 Corrective Actions

A. Gaps in performance between the Target and Actual are identified through various means, such

as from customer complaints, non-conforming products, internal audits.

B. AAL Management reviews the gaps and identifies corrective actions across the organization.

These remedial actions are then broken down by functional areas and assigned to specific action

owners in each function.

C. Through reviews and audits AAL Management ascertains that the identified gaps are closed

effectively, and that there is a process to prevent the Gaps from recurring. These are documented

as Updates and Revisions to the relevant processes and guidelines and shared across AAL.





5.6 Environment, Regulatory Compliance

AAL shall implement necessary processes to ensure the requirements for compliance to environmental,

regulatory, product and work-place safety and any other relevant contexts are consistently met.

A. Environmental Compliance: AAL shall ensure adequate understanding and awareness among

its team on the requirements for material packaging, storing, handling and disposal.

B. Regulatory Compliance: AAL shall ensure strict compliance to the Regulatory Compliance

C. Customer Requirement Compliance: As described in AAL-QMS 3.3.1 and 3.4.1

D. Safety Compliance: As described in AAL-QMS 3.3.3

E. Compliance Process: Management shall authorize specific personnel in each relevant function

e.g. Design, Production, Procurement, Customer Relations Management, to create the process for

compliance in their function. It reviews and integrates these function-specific processes to one

enterprise-wide process for compliance, and formally approves it. The approved process is

documented and shared across the organization.

F. Implement Compliance Process: Relevant functions shall implement the Process, with the

Management Representative overseeing and coordinating implementation at organization-level.

G. Continuous Improvement: AAL is committed to continuously improving its Compliance, and shall

achieve this by periodically reviewing it through internal audits and external audits as required.


6 Appendix - A

6.1 Process Monitoring and Control - templates

6.1.1 Incoming Inspection Report Suitable Incoming Inspection Format shall be designed to include identity of the supplier, item, quantity

received, any special requirements, and space for indicating evidence of inspection, status of acceptance,

disposition and identity of inspector.

6.1.2 Shipping Document The form should contain any special conditions included in the customer's order such as, Requirements

for data, test reports, certifications, marking or packaging. The form should also include some space to

indicate evidence of acceptance by inspection was performed

7 Appendix - B

7.1 Calibration Intervals List of equipment and measuring instruments that require periodic calibration shall be identified and

calibration shall be carried out by in-house group or a certified agency.

Equipment Interval Master Gage Block Set Two Years

Thread plug and ring gages Six Months

Micrometer One Year

Calipers One Year

Surface Plate Three Years

Hole Plug Gage After Each Use

NOTE: Items and Intervals mentioned here are to serve as guideline. Interval to be determined by use, potential wear

and calibration history of each item.

Incoming Inspection, Shipping and Transportation and Calibration formats have already prepared which may

be suitably relooked.

To be updated

Date post:	11-Mar-2020
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