Upgrade to Aerospace products using the AS9100D Standard ...

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Upgrade to Aerospace products

using the AS9100D Standard

February 2021


Outline

• What are Management System Standards and AS9100D?

• Requirements beyond ISO 9001:

▪ New Terms Calibration

▪ Competence and Awareness

▪ Documents and Records

▪ Operation Planning & Control

▪ Requirements for Products

▪ Design and Development

• Implementing this standard

▪ Purchasing

▪ Production

▪ Post-Delivery Activities

▪ Control of Non-conforming

▪ Measurements


Ask Yourself Three Questions…

1. How should we manage the business?

▪ What are accepted best practices for running a business?

2. Is it written down?

▪ Do we have documented policies and procedures? Do we keep records?

3. Are people doing it?

▪ How do we check if people are following the policies and procedures?

▪ Look to Management System standards, such as ISO 9001 and AS9100

▪ e.g., Quality policy, quality manual, procedures, flowcharts, records

▪ Interview people. Audit processes. Identify weaknesses and fix them.

Plan-Do-Check-Adjust


Many Management System Stds. Are Rooted in ISO 9001

Quality

Management

System

ISO 9001

Many Others

Aerospace

AS9100

Environmental

ISO 14001Medical Device

ISO 13485

Food Safety

ISO 22000

and others

Automotive

IATF 16949

Health &

Safety

ISO 45001


What is the AS9100 Standard?

• The standard for Aerospace quality management systems

• For Manufacturers in the Aviation, Space, and Defense supply chains

• Expectation from many Aircraft, Satellite, and Defense manufacturers

• Sponsored and maintained by SAE International

• Based on ISO 9001 standard,

adds some requirements

• 80% is the 9001 standard


Like ISO 9001, It Is a Standard Of Best Practices

• AS9100D incorporates all of ISO 9001:2015, plus additional

requirements for

▪ Calibration

▪ Competence & Awareness

▪ Document Control

▪ Operational Planning

▪ Requirements for products

▪ Design & Development

▪ Purchasing

▪ Production


New Terms

• Counterfeit Part: An unauthorized copy, imitation, substitute, or modified part.

• Critical Items: Items which have significant affect on product realization and use.

E.g., Mission critical, safety critical, fracture critical, or key characteristic

• Key Characteristic: An attribute or feature whose variation has significant impact

on the product fit, form, function, performance, service life or producibility,...

• Product Safety: The state in which a product performs without causing risk of harm

to persons or damage to property.

• Special Requirements: Specified by customer with some probability of not being

achieved


Calibration

▪ Includes test hardware, test software, automated test equipment, and plotters

used to produce verification data. Includes personally owned and customer

supplied equipment.

▪ Register of Calibrated Instruments, including:

• equipment type,

• unique identification ,

• location,

• calibration/verification method,

• frequency and

• acceptance criteria

▪ Must have positive recall of instruments for

recalibration and verification.

▪ Calibration performed under suitable environmental conditions.


Competence and Awareness

• Competence of Personnel

▪ Note: Consideration given for the periodic review of competence

• Awareness

▪ Quality Policy, Objectives, contribution to QMS, and implications

▪ Relevant QMS documentation and changes thereto

▪ Their contribution to product quality

▪ Their contribution to product safety

▪ The importance of ethical behavior


Documents and Records

• Approval implies authorized persons and approval methods

are identified

• Obsolete documents are removed or suitably identified or

controlled, if retained.

• When documented information is managed electronically,

data protection processes must be defined

▪ (e.g., protection from loss, unauthorized changes,

unintended alteration, corruption, physical damage)


Operation Planning and Control

• Determining processes & controls to manage critical items,

including variation control for key characteristics

• Representatives from multiple functions in operation planning

• Determine process & resources to support use & maintenance

• Determine products & services from external providers

• Establish controls to prevent delivery of nonconforming products


Operation Planning and Control

• Operational Risk Management

▪ Typically Process Failure Modes and Effects Analysis (PFMEA)

• Configuration Management

▪ Tracking versions of components used in assembly of each product

• Product Safety

▪ Controlling processes to ensure product safety through its lifecycle

• Prevention of Counterfeit parts

▪ Actions to prevent unauthorized products and purchased components


Requirements for Products

• Determining requirements (typically in quoting)

▪ Special requirements (challenges) of products are determined

▪ Operational risks (e.g., new technology, ability and capacity to provide, short delivery

time frame) have been identified

• Review of requirements (typically in order entry)

▪ Review is coordinated with applicable

functions of the organization

▪ If some customer requirements cannot be

fully or partially met, then a mutually

acceptable requirement must be

determined with the customer


Design and Development

• Planning

▪ Defining distinct activities including tasks, resources, responsibilities, design content,

inputs, and outputs

▪ Considers ability to provide, verify, test and maintain products

• Inputs

▪ Consider the potential consequences of obsolescence (e.g., materials, processes,

components, equipment, products)

• Controls

▪ Participants in design reviews include representatives of concerned functions

▪ Tests must be planned, controlled, reviewed and documented


Design and Development, cont’d

• Design Outputs

▪ Specify critical items, key characteristics, and specific actions

▪ Documents are approved prior to release

▪ Identify data required to identify, manufacture, verify, use, and maintain products

• Design Changes

▪ Defined process to notify customers prior to

making changes affecting customer requirements


Purchasing - Suppliers

• The organization will:

▪ Use and be responsible for customer-specified suppliers

▪ Identify and manage risks of purchased items and suppliers

▪ Defined process for supplier approval

▪ Maintain a register of approved suppliers, including approval status, and

scope

▪ Define actions when supplier performance fails to meet expectations

▪ Define retention requirements for supplier records


Purchasing - Controls

• Verify that purchased items meet requirements

▪ Verification performed according to supplier performance, risk and potential

for counterfeit parts

▪ Positive recall if purchased parts released prior to verification results

▪ Register of delegations lists scope & requirements of testing performed by

supplier

• Process to evaluate test data in supplier generated test reports


Purchasing – P.O.s include, as applicable:• Special requirements, critical items, or key characteristics

• Test, inspection, and verification activities

• The need for:

▪ A quality management system, customer-designated providers, notification of

nonconforming processes, products, or services.

▪ Prevention of counterfeit parts, notification of process changes, flow down of

applicable customer requirements, retention of records (including retention time and

disposition)

• Right of access of the organization, customer, and regulatory authorities

to applicable areas and records


Control of Production

Controls include:

▪ Criteria, when test to be done, Records of results, instruments

▪ Sampling based on statistical plans

▪ Criteria for workmanship

▪ Accounting for all product

▪ Records that In-process inspections were completed

▪ FOD prevention

▪ Positive control of pre-released product for identification and recall


Control of Production & Service

• Control of Equipment, Tools, and Software programs

▪ Validated prior to release to production. Defined storage requirements and

periodic condition checks

• Validation and Control of Special Processes

▪ Defined validation process including criteria, when to reapprove, approval of

facilities and equipment, qualification of personnel, monitoring methods, records

requirements

• Production Process Verification

▪ First Article Inspection to verify capability to make conforming product


Control of Production & Service

• Product configuration records (actual vs. planned)

• Control of acceptance media (e.g. stamps, electronic signatures, passwords)

• Traceability including:

▪ Unique IDs/batch lots, traceable to components/materials and production records

• Preservation of product:

▪ Considering cleaning, FOD, handling & storage, labels & warnings, shelf life,

HAZMAT (if applicable)

• Process changes

▪ Persons authorized to approve process changes are identified


Post-Delivery Activities

• Analyze in-service data

▪ E.g., performance, reliability, and lessons learned

• Control technical documents

▪ Including product use, maintenance, repair, and overhaul

• Controls for off-site work

• Product and customer support

▪ queries, training, warranty, maintenance, parts, resources, obsolescence

• Problems detected after delivery are investigated

and reported


Control of Non-conforming Product

• Documented procedure, including

▪ Defined responsibility/authority for disposition and how persons are authorized

▪ Reporting of affected product to customers and interested parties

▪ Defined corrective actions for delivered products

• Use-as-is and repair requires approval by design-responsible org.

• Scrap is conspicuously marked or physically controlled until destroyed

• Counterfeit (and suspect items) are controlled


Measurements

• Customer Satisfaction

▪ Must include product quality, on-time delivery, complaints, corr. action requests

• Internal audit

▪ Audit includes organization, customer,

and regulatory requirements

• Management Review

▪ Inputs include on-time delivery

▪ Outputs include risks identified

• Corrective Actions

▪ Flow down to supplier when responsible

▪ Specific actions when timely C/As are not achieved


Implementing This Standard

• For most organizations, start with ISO 9001 then add AS9100

• The majority of added requirements are in:

▪ Operations Planning

▪ Design

▪ Purchasing

▪ Production

▪ Post-delivery

• Work through process-by-process to implement new requirements

• Then perform an Internal Audit to verify you’re meeting the standard

Design and Post-delivery

actions are not applicable

for many organizations!


Questions?

Andrew Porter

▪ Senior Consultant, WMEP Manufacturing Solutions

[email protected]

608.215.3632

▪ Auditing and Implementing:

• Quality, ISO 9001

• Aerospace, AS9100

• Medical Device, ISO 13485

• Electrical devices for explosive

environments, ISO/IEC 80079-34

mailto:[email protected]

Upgrade to Aerospace products using the AS9100D Standard ...

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