AS9100D: Why it matters & Why you need it · Why it matters & Why you need it. with Paul Harbath. The University of Utah Manufacturing Extension Partnership Center presents: Operational

AS9100D:

Why it matters & Why you need itwith Paul Harbath

The University of Utah Manufacturing Extension Partnership Center presents:

Operational Excellence Services

Copyright - OpEx Services Sept 2017


Phone 801.603.5246E-mail [email protected]: https://www.linkedin.com/in/paulhleanauthor

Paul Harbath is an industry expert that specializes in quality management system implementation and continuous improvement processes for small manufacturing companies.

Over 33 years of hands on experience in quality management systems and helping small companies understand/implement Lean/6-Sigma. Paul has a demonstrated ability to connect with the value adding employees by simplifying complex technical issues.

mailto:[email protected]

https://www.linkedin.com/in/paulhleanauthor


Here’s what we’ll talk about Why should you consider AS9100D registration Basic understanding of (limited time)◦ ISO9001:2015 history◦ And sector specific standards like AS9100D

What is a quality system standard?◦ AS9100D Acronym CL-PSO-EI◦ AS9100D key points

Implementation of AS9100 in your business◦ Size of your organization is critical◦ Let’s talk details

Changes from revision AS9100C to AS9100D Questions


Why become registered?1. Growth

◦ More demanding customers require it◦ Marketing tool◦ Higher margin business◦ Long term contracts

2. Increase customer satisfaction◦ Must understand customer value◦ Systematic method to assure customer satisfaction◦ My customer says so…

3. Process based system◦ Must manage by process◦ Critical for small organizations

4. Risk based◦ Critical for small businesses

5. Better engagement of employees◦ Enhances professionalism

6. Drives a continuous improvement culture◦ Puts lean/6-sigma higher on the list of things to do


History of ISO9001

Mil-Q-9858A April 1959

ISO9001:1987

TQM Lean

6-Sigma

Pro

cess

B

ased

Doc

umen

tati

onB

ased

Year1940’s 1980’s 2000 2015

Toyota

ISO9001:2000

ISO9001:2015

ISO9001:1994

ISO9001:2008


ISO9001:2015 BMS structure

ISO9001:2015 Quality Management System Base Standard

ISO14001:2015Environmental

AS9100DAerospace

ISO 45001:2018Safety

IATF 16949:2016Automotive

Sector SpecificOther BMS standards

AS9100 OASIS 9/13>17k total

79 in Utah622 Rev D3 Utah Rev D


AS9100D vs ISO9001:2015 AS9100D

requirements in bold Additional focus on◦ Process control◦ Purchasing


The principles of AS9100D

The standard is built on principles

The principles are in clause 0.2 of the standard


Structure of AS9100DC 4 – Context of organizationL 5 – Leadership-P 6 – PlanningS 7 – SupportO 8 – Operations-E 9 – Performance EvaluationI 10 – Improvement


Definitions


Must do “Shalls” The shalls listed in the standard must be met

For example◦ You are responsible for the conformity of

product from suppliers even if the customer tells you to use a certain supplier


Maintained vs retained documentation

Maintained◦ Controlled by revision◦ Think 2016 tax form

Retained◦ Evidence of system◦ Think completed 2016

taxes


“Big 3” of ISO9001:2015

ManagementReview

Plan QMS

Implement QMS

Internal Audit

Corrective Action

Internal audit Corrective

action Management

review

AS9100D adds◦ Purchasing


Risk Based Thinking You will decide how you

implement AS9100D requirements

You must understand the risks in your organization

Formal method of risk analysis◦ Define potential risks◦ Quantify risk◦ Take action on

unacceptable risks

This allows small companies to structure the requirements differently than large


Implementation


Define Exclusions

The AS9100D standard requires that you define any specific exclusions to the standard

For example◦ If you do not design products you can exclude

clause 8.3


Procedures required

There are 2 procedures required

Define the non-conforming and corrective action processes

Note “Maintain documented information” You must also “Retain info of non-conformities

and corrective actions”


Quality manual optional Creating a quality manual is optional

I recommend creating one since your customers will ask for one.


Define your internal audit system Define internal audits◦ Must have schedule◦ Must cover all areas of standard

I recommend creating a schedule that fits your processes


Exercise the “Big 3”

Use internal audit◦ To create a gap analysis

Use corrective action system◦ To implement the changes

Management review◦ Make sure all leadership

understands the status of you QMS

Remember the“Big 4”


Create SME’s (larger organizations)

Smaller organizations◦ Usually one/two employees handles and

understands requirements◦ Become the experts

Larger organizations (>20 people)◦ Create SME’s (subject matter experts) for the

various QMS areas purchasing, operations, contract review, etc.◦ The SME’s have full responsibility to assure

QMS requirements are being met


Top 10 questions about AS9100D

1. Do I have to do all the paperwork for all parts even commercial?

2. How long will it take to become registered?3. How many procedures do I need?4. Do I have to have work instructions for all operations?5. How much does it cost?6. Do I have an audit from the registrar every year?7. What measurement equipment must be calibrated?8. Can I use my existing suppliers?9. If I become registered to AS9100D how do I register to

ISO9001:2015?10. How much more work is it to register to AS9100D?


Moving from Rev C to Rev D

The most significant changes to the standard is the reorganizing of the clauses

CL-PSO-EI The changes between AS9100C and

AS9100D is small For participating in this webinar you can

get an outline of the changes We’ll show you how in next slides…


Request an outline of changes

The MEP will send out a summary of the changes from C to D

MEP is also offering a free on-site assessment. You’ll get more details

Date AS9100C will become inactive

September 15th 2018


Final Thoughts Don’t’ over complicate your systems◦ It is very common for me to reduce the amount

of documentation by 50% in new companies that have started

The first audit will be the easiest audit you will have…

The MEP will offer a free high level gap analysis◦ See next page…


AS9100D Assessment

For attendees of this webinar the MEP will offer◦ Free high level on-

site assessment◦ Will identify broad

gaps


AS9100D tips for OpEx Services

Weekly I send out a tip about AS9100D If you would like me to add you to the list

send me your e-mail address

[email protected]

This is not a sales e-mail…



Questions


Contact us:

Paul [email protected]


[email protected]



Documents

AS9100D: Why it matters & Why you need it · Why it matters & Why you need it. with Paul Harbath. The University of Utah Manufacturing Extension Partnership Center presents: Operational