delegation notes 1

7/28/2019 Delegation Notes 1

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DQS-ULM

anagementSystemsSolutions

Training Program

on

AS 9100- Rev C Implementation

DQS-ULManagementSystemsSolutions


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I am


The differences between AS9100 Rev B & C.

Required changes for the current Quality Manual.

Road map for Upgrading to Rev C.

Procedural requirements for Rev C.

PROGRAM CONTENT


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AS9100 REVISION OBJECTIVES

Incorporate ISO 9001 :2008 changes

Expand the scope to include Land and Sea based systems

for defense applications

Ensure alignment with IAQG strategy (On time , on quality

performance)

Adopt new requirements based on stakeholder needs

Improve existing requirements where stakeholders

identified need for clarification, including when a

documented procedure is required.


The Establishment of common requirements, for useThe Establishment of common requirements, for use

at all levels of the supply chain, by the organizations around tat all levels of the supply chain, by the organizations around thehe

globe, should result in:globe, should result in:

Improved QualityImproved Quality

Improved SafetyImproved Safety

Decreased CostsDecreased Costs

Reduction in customer specific requirementsReduction in customer specific requirements Reduce variationReduce variation

AS9100 REVISION OBJECTIVES


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AS9100 Rev CAS9100 Rev CAS9100 Rev CAS9100 Rev C

OverviewOverviewOverviewOverview


SUMMARY OF THE CHANGES

6 ADDITIONS

8 REVISIONS / RELOCATIONS

3 DELETIONS

AND AS9101D REQUIREMENTS


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6 ADDITIONS IN AS9100

Clause 3.1 - Risk

Clause 3.2 -Special Requirements

Clause 3.3 - Critical Items

Clauses 5.2/8.2.1 Customer Focus/Satisfaction

Clause 7.1.1 - Project Management

Clause 7.1.2 - Risk Management

ADDITIONS


8 REVISIONS / RELOCATION IN AS9100

Clause 1 - 9100 Scope and Application

clause 4.1 QMS General requirements

Clause7.1.3- Configuration Management

Clause7.1.4 Work Transfer

Clause 7.4.1 Recognition of Supplier Quality Data

Clause 7.4.1 Approval status for suppliers

Clause 7.5.1.1 Production Process Verification

Clause 8.2.4 Sampling Inspection

REVISION / RELOCATION


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3 DELETIONS AS PER AS 9100

Clause 4.2.2 Quality Manual Relationships

(Still available in AS9101)

Clause 7.4.3 Validation of Test Reports

Clause 8.2.2 Detailed Tools and Techniques

(Process approach to be used for internal audit)

DELETIONS


CHANGES IN DETAILCHANGES IN DETAILCHANGES IN DETAILCHANGES IN DETAIL


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TIME FRAME


Risk

An undesirable situation or circumstance that has both a

likelihood of occurring and a potentially negative consequence

Special Requirements

Those requirements identified by customers or determined by the

organization, which have high risks to being achieved, thus

requiring their inclusion in the risk management process.

SOME IMPORTANT DEFINITIONS


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Critical Items

Those items having significant effect on the product realization

and use of the product; including safety, performance, form, fit,

function, producilbility, service life etc.; that require specific

actions to ensure they are adequately managed.

Key Characteristics

An attribute or feature whose variation has a significant effect on

the product fit, form, function, performance, service life or

producibility, that requires specific actions for the purpose ofcontrolling variations

SOME IMPORTANT DEFINITIONS


SOME NEW REQUIREMENTS INTRODUCED

IN AS9100 Rev C


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PROJECT MANAGEMENT

Project Management

As appropriate to the organization and the product, the

organization shall plan and manage product realization in

a structured and controlled manner to meet requirements at

acceptable risk, within resource and schedule

constraints.


1.Agree precise specification for the project - 'Terms of Reference'

2.Plan the Project - time, team, activities, resources, financials -

using suitable Project management tools

3. Communicate the project plan to your project team - and to any

other interested people and groups.

4. Agree and delegate project actions.

5. Manage and motivate - inform, encourage, enable the project

team.

6.Check, Measure, Monitor, Review project progress- adjust

project plans, and inform the project team and others.

7. Complete Project - review and report on project performance;

give praise and thanks to the project team.

8.Project followup - train, support, measure and report results and

benefits.

PROJECT MANAGEMENT PROCESS


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Critical path analysisGnatt Chart

Cause & Effect diagram Brainstorming

TOOLS FOR PROJECT MANAGEMENT


***- Main Tool

** - Optional / Secondary Tool* - Sometimes Useful

B- BrainstormingF- Fishbone Diagram

C- Critical Path Analysis flow diagramG- Gantt Charts

*****Format for communications, presentations, updates, progress reports,etc

*****'Snapshot' or 'map' overview - non-sequential, non-scheduled

********Troubleshooting, problem identification, diagnosis and solutions

******Monitoring, forecasting, reporting

*******Financials - costing, budgets, revenues, profits, variances, etc

*****Identifying and sequencing parallel and interdependent activities and stages

*****Scheduling and timescales

******Gathering and identifying all elements, especially causal and hidden factors

*****Project brainstorming and initial concepts, ideas, structures, aims, etc

GCFBTasks

TOOLS FOR PROJECT MANAGEMENT


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WRITE A PROJECT PLAN USING ANY TOOL FOR THE

FOLLOWING CASE

EXERCISE

Requirements

-Delivery with in 30 days

of receiving the PO

-Lead time for

procurement is 2 weeks

-Involves mechanicalassembly (machining, HT,

Painting), electrical assy

and then testing .


RISK MANAGEMENT

The organization shall establish, implement and maintain a process

for managing risk to the achievement of applicable requirements,

that includes as appropriate to the organization and the product

a) assignment of responsibilities for risk management,

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

acceptance),

c) identification, assessment and communication of risks throughout

product realization,

d) identification, implementation and management of actions to

mitigate risks that exceed the defined risk acceptance

criteria, and

e) acceptance of risks remaining after implementation of mitigating

actions.


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RISK MANAGEMENT PROCESSRISK MANAGEMENT PROCESS



Risk Planning

The step of developing and documenting comprehensive and interactive strategiesand methods for identifying and tracking risk areas, training, developing riskmitigation plans, performing risk assessments to determine how risks havechanged, and planning/obtaining adequate resources.

Risk Identification

The step of discovering and defining all risks inherent in your program or project.

Risk Assessment

The process of analyzing and prioritizing program and process risks against cost,schedule and/or performance criteria.

Risk Handling The step that identifies, evaluates, selects, and implements actions in order to

reduce risk likelihood or consequence to an acceptable level.

Risk Monitoring

The step that systematically tracks and evaluates the performance of Risk Handlingactions against established metrics throughout the acquisition process.


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Complexity of Design

Criticality of Product for End Use

New or Unproven Process or Technology

Organizational Capability to Design or Build Product

New or Unproven Process to Organization

New Technology to Company

Items or Requirements That are Candidates for Risk

Management Processes

Others??



Identification

Discovering and defining all risks inherent in your program,project, process, or task.

Communication

Communicating Risks to all Relevant Individuals andProcesses

Risk Understanding

Understanding the Risks and How they affect your Function orProcess

Decision Making (Risk Based)

Making Choices on application of Individual Options and

Process Options Risk Behaviors

Knowledge of Identified Risks

Knowledge of Process Options

Application of Identified Risk Topics to Process Options



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Proposal Contract Design Manufact.ProductDelivery

Integrate

Purchasing

All Requirements are not created equal

Monitoring and Inspection Activities

Operational Options that Need RiskOriented Decisions associated withCritical Requirements

Design Approach

V&V Approach

Monitor & Insp. Approach

Supplier Oversight

RFQ

Suppliers

Communication ofSupplier Requirements

-Key Characteristics-

WhereIdentified

HowCommunicated

WhatDecisions



Identify risk in the following areas/process/ functions:

HR, Purchase, Supplier, Manufacturing, Process

Engineering, Design & development, Quality, Dispatch

And identify mitigation plan for them.

EXERCISE


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The organization shall establish, implement and maintain a

configuration management process that includes, as

appropriate to the product

a) configuration management planning,

b) configuration identification,

c) change control,

d) configuration status accounting, and

e) configuration audit.

CONFIGURATION MANAGEMENT


Identify configurable items in your organization and prepare a

plan for configuration management

(Configuration management plan is a document defining how

configuration management will be implemented including

policies and procedures for a particular acquisition

or program)

EXERCISE


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PROCEDURAL REQUIREMENTS FOR AS9100 Rev C


STEP-I

Revise Manual to AS9100 rev C

Revisit to manual for various new clause requirements ,

relocations and deletion with respect to Rev C of the standard


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STEP-II

MODIFY PROCESS AS PER AS9101 Rev D


a) are identified and appropriately defined;

Should be based on Process and not on departments

Eg: Purchase department can be

- Purchase process,

- Supplier management Process (selection, evaluation and re

evaluation)

PROCESS REQUIREMENTS


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LIST THE PROCESS IN YOUR ORGANIZATION

EXERCISE


b) are sequenced and interactions are defined

(see 9100-series standards, clause 4.1.b);



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FOR THE LISTED PROCESS MAP THE INTERACTIONS

EXERCISE


c) have responsibilities assigned and responsible functions identified;



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SELECT ONE ACTIVITY LIKE WRITING PROCESS

SHEET AND WRITE THE REPONSIBILITY OF EACH

PROCESS INVOVLED

EXERCISE


d) have relevant process controls defined;

E.g.:

1. Assembly Process :First Time Pass in Final Testing

2. Assembly Inspection : Cycle time for inspection

3. Recruitment Process : To hire the specified man power

in a year = (No. Hired / no.

Planned) x 100Target: >90%



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Try to keep the controls (Objectives/ Targets) SMART

1. Specific Objectives should specify what they want to

achieve.

2. Measurable You should be able to measure whether you are

meeting the objectives or not.

3. Achievable - Are the objectives you set, achievable and

attainable?

4. Realistic Can you realistically achieve the objectives with

the resources you have?5. Time When do you want to achieve the set objectives?



e) have the availability of resources and information required to

operate and support associated activities, including appropriate

training and competency of personnel;

Eg: For Configuration Management Process the resources are

Configuration Management tool for version controlling

CSRM & List of CI template

CR Log, PCA/FCA

Traceability Matrix

Personnel with training on Configuration Management



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f) are monitored, measured, and analyzed against planned results(determination of process effectiveness);

Eg: 1.To hire the specified man power in a year = (No. Hired / no.

Planned) x 100

Target: >90% actual : 100%

2. No. of Projects delivered on time to total no. of projects

should be >85% actual 86%

This should be defined for all the process identified in the QMS

and need to be monitored, measured and analyzed against planned

result.



g) have actions implemented to achieve planned results and

to promote continual improvement; and

Eg : No. of Projects delivered on time to total no. of projects should

be >85%

Actual : Q1 : 84% Q2 : 75%

Then need to take a action

option 1: out source some of the activity,Option 2: have an extra shift for completion of task

And have a follow up regularly as per the project plan



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h) are effective in achieving the desired results (e.g., verifyperformance information available - percentage of nonconforming

parts/products, percentage OTD).



TOOL which can help in defining the process as per Rev C

and a tool for conducting internal audit.


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SAMPLE TURTLE


SELECT A PROCESS AND COMPLETE THE PROCESS

TURTLE, COMPELTING ALL THE FIELDS IN THE

TURTLE

EXERCISE


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A tool which helps in rating my process performance

PEAR


Example

PEAR


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EXERCISE

Try to complete the PEAR for the process for which you

completed the turtle


1. Check the QMS by answering OER of AS9101 D

2. Release the revised QMS for use.

3. Conduct an internal audit using turtles as tools

4. Try to collect previous 12months data for process

and do a analysis as per set controls.

5. Close all the NCs by correcting the process and try

to rate the NCs as defined in AS9101D

STEP-III


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That completes the implementation of AS9100 Rev C


BRAINSTROMING SESSIONBRAINSTROMING SESSIONBRAINSTROMING SESSIONBRAINSTROMING SESSION


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THANK YOUTHANK YOUTHANK YOUTHANK YOU

delegation notes 1

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