22d key process identification and management within … barbara butrym_key... · key process...

22D Key Process Identification and

Management within the Aerospace Standards

By

AS9100 Auditor, Trainer and Consultant, Barbara Butrym

Abstract

One of the key requirements within the aerospace standards (AS9100, AS9120, and AS9110) is the identification of key processes and the subsequent identification of key performance indicators; this is often a weakness within any management system.

We will help you understand this requirement and show you that it is easier

to implement than what people assume and it can also benefit your 0rganisation once completed.

Today’s session will guide you through the process of identifying your key processes and indicators in preparation for implementing your AS Quality Management System, as well provide guidance for interpreting the PEAR (process effectivity assessment report) your AS9100 auditor will issue you and how to use the PEAR internally to add value to your internal audits

October 22, 2014 2ASQ NEQC Conference, Springfield, Massachusetts

Introduction to the Process Concept


What is a Process?

• A series of operations or steps that results in a product or service.

• A set of causes and conditions that work together to transform inputs into an output.


Loading or unloading

stuff

Dropping anchor

Arranging travel

Preparing a report

Processing payments

Admitting patients

Starting propulsion

equipment

Purchasing supplies

Plating metal

Training people

Preparing a budget

Transporting hazardous

materials

Examples of Processes


Significant and Critical Processes

• Significant Processes– Are processes by which the mission-essential work

of the organization is accomplished.

– Contribute directly to meeting the needs and requirements of customers.

– Can be traced from output (to external customer) back to input (to the organization).

• Critical Processes– A stage within a significant process.

– One that is deemed as most important for control and improvement.


System vs. Process• System

Pronunciation sI stEm

Definition A group of related things or parts that function together as a whole.

Example The school system in our city.

• ProcessPronunciation pra sehs

Definition A systematic sequence of actions used to produce something or achieve an end.

Example An assembly-line process.

A System is made up of Processes


System

for

Defense

y

n

Army

Marines

Air Force

Navy

Systems and Subsystems

There are high level systems and low level systems. High level systems are composed various sub-systems.


Organization As An Extended System

Suppliers of materials and

equipment

ABCD

Design and redesign

Consumers

Consumer Research

Distribution

Production, assembly, inspection

Test of processes, machines, methods

Receipt and test of materials

(Deming, 1986)


Account Management

Sales / Marketing

Order Receipt

Order toMFG.

Procure Material

Build Product

Ship Product

BillCustomer

CollectMoney

Marketing ProcessSales ProcessQuote ProcessCredit Approval

Order ReviewGen. Doc.Acknowledge. OrderNotify Mfg.

Verify InputsPlan the JobRelease for Purch 7Mfg.

Review ReqmtsMake vs. BuySelect SupplierIssue RFQPlace OrdersEval. Incoming MatlsMaterial Dispo.Autorize Supp. pay

Review Doc. Pack.Kit MaterialsSet up Equip.Mfg. per Route CardPackageSend to Finish goods

Confirm Date Create Pack. Docs.Create / Dist InvoiceSched. CarrierGenerate Ship. Docs.Pass to shipperFile Paperwork

Mail Invoice Receive PaymentsResolve Disputes

ManagementProcesses

Results / ForecastsBusiness PlanMgmnt Mtgs.

DesignEngineering

QualitySystems

Internal AuditsProcedures &

Standards

SupplierApproval

DocumentControl

Control of TestEquipment

Data Security

Training

PersonnelProcesses

Customer Complaints

FacilitiesProcesses

CorrectiveAction

CustomerServices

MaterialStocking

FinancialProcesses

PreventativeMaintenance

Support Functions / Processes



Account Management

Sales / Marketing

Order Receipt

Order toMFG.

Procure Material

Build Product

Ship Product

BillCustomer

CollectMoney

Mrkting ProcessSales ProcessQuote ProcessCredit Approval

Order ReviewGen. Doc.Acknowl. OrderNotify Mfg.

Verify InputsPlan the JobRelease for Purch 7Mfg.

Review ReqmtsMake vs. BuySelect SupplierIssue RFQPlace OrdersEval. Incoming MatlsMaterial Dispo.Autorize Supp. pay

Review Doc. Pack.Kit MaterialsSet up Equip.Mfg. per Route CardPackageSend to Finish goods

Confirm Date Create Pack. Docs.Create / Dist InvoiceSched. CarrierGenerate Ship. Docs.Pass to shipperFile Paperwork

Mail Invoice Receive PaymentsResolve Disputes

ManagementProcesses

Results / ForecastsBusiness PlanMgmnt Mtgs.

DesignEngineering

QualitySystems

Internal AuditsProcedures &

Standards

SupplierApproval

DocumentControl

Control of TestEquipment

Data Security

Training

PersonnelProcesses

Customer Complaints

FacilitiesProcesses

CorrectiveAction

CustomerServices

MaterialStocking

FinancialProcesses

PreventativeMaintenance

Support Functions / Processes



Quality Through Process Improvement

Customer

Customer Feedback

Product or

Service

Machines Methods

MaterialPeople Environment

Process Feedback

Feedback is a cornerstone, so to speak, of AS 9100. The implication throughout the standard is that you will manage with data.


An Extended SystemSub-SystemProcess Within the System System

End-userSuppliers

Long-term

feedback

Long-term

feedback

Short-termFeedback

Short-termFeedback

Yes

No

YesNo

Environment Environment

Internal


Systems / Processes

Inputs OutputsOutcomes

Product

or

Service

End-userSupplier

Machines Methods


Measures In The Extended System

Convert to Measurables When None Exist


Quality Through Process Improvement

Customer

Customer Feedback

Product or

Service

Machines Methods


Process Feedback

Feedback is a cornerstone, so to speak, of AS 9100. The implication throughout the standard is that you will manage with data.


AS 9100 QMS ‘Process Model’

Quality Management SystemContinual Improvement

CustomerSatisfaction

CustomerRequirements

ManagementResponsibility

ResourceManagement

Measurement,Analysis,

Improvement

ProductRealization

Input Product

Output

Quality ManagementSystem

Representation 1


Ok , so what does that mean to me as I implement AS9100 ?


What are my key processes?

• How many do we have?

• How do we choose them?

• How do we document them?

• Who is the process Owner?—What does that mean?


What is a key process indicator?

• What controls the process?

• What are the variables?

• How do you know?

• How do you measure them?

• Who do you report them to?

• In what format?

• Then what?


A typical set of processes for many companies would be

1) Sales

2) Engineering

3) Purchasing,

4) Quality,

5) Production,

6) Receiving / Storeroom / Shipping,

7) Support (Management Related).

Most all processes have sub processes within them. The actual titles

vary greatly from one organization to another.


Is the process effective?

• How do you know?

– What are some ways to verify effectivity?

– What are the Tools the auditor will use?


Process

(Steps)

WHATNecessary facilities, equipment and materials. Preventive

maintenance, environment.

TURTLE DIAGRAM For Process:_____________

WHOProcess owner, customers, skills, training, training records.

HOWSupport processes, methods & procedures, specifications,

standards, maps, forms.

MEASUREAnalysis of process effectiveness, Goals, Metrics, product

measurements, controls.

INPUTS (What is needed to produce the

output) Materials/Components,

specifications.

OUTPUT Product, reports, service.

Issues: NC OB:


AUDITOR TURTLE DIAGRAMTraining/Resources

WHAT WHO• What materials, equipment and/or other resources are required to

complete this process? An identification of the need for training and any materials and resources as deemed necessary by the trainor and needed to perform the process being trained. A training area, boards, projectors, handouts, reference material ect as deemed necessary, by the supervisor, job description or requirement.. Appropriate resources to perform daily functions either time, materials, equipment or people

• Has the process owner been identified? Each process owner is responsible or their training and processes/equipment, HR is the keeper of the records• What other staff members and/or suppliers are involved in the process? As assigned

• How does the company ensure training is effective? Each process or training has an appropriate measure of effectivity

INPUT OUTPUT

Customer wants? Customer gets?The customer is the owner of the process needing training or facility department with a resource need

A trained, effective, efficient workforce with appropriate resources to economically and effectively perform its processes

Input Requirements Output RequirementsWhat are the inputs that determine what the process should produce? MR identifies a resource need, A CA/PA requiring resources

The identified needs are met

• Include any Customer/Internal/Governmental and Regulatory Requirements driven by MR of the requirement. NA

• What documentation is being created when this process is completed? Training, purchasing and facilities records

• Does this output create an input into another process? Not directly, as and assist or enhancement/CI

MEASURE HOW

(Recommend list 3.) Support Processes - Who helps and how? (Recommend list 4.)

• What measuring tools are used to monitor the effectiveness of this process? (Metrics, KOI's) # of employees trained/certified and the effective ness measure as appropriate.

• How is continual improvement of this process ensured? Through periodic Management Review of resources. Through feedback from employees after formal training sessions...negative feedback is reviewed

• Have support processes been identified? Appropriate training • Have linkages to support processes, procedures and methods

been established? ALL QMS processes are linked through the QMS master list of procedures

Procedures/Control Documents• Is this process properly documented? Training Records control is documented. Training procedure is documented.• What Work Instructions and/or Forms are affected by this Process? All We and forms• Are records appropriately stored and maintained? Yes

Process Name/

Description

provision of resourcesProcess steps/Activities

What are the most important

steps in completing this

Process? An effectively

trained workforce and

maintained facility

An example of a Turtle Diagram for the Training process


The body---the process

Process Name/

Description

provision of resources

Process steps/Activities

What are the most important steps in

completing this Process?

An effectively trained workforce

and maintained facility


Lets break the turtle down legs 1, 2

WHAT WHO

• What materials, equipment and/or other resources are required to

complete this process? An identification of the need for training and any materials and resources as deemed necessary by the trainer and needed to perform the process being trained. A training area, boards, projectors, handouts, reference material ect as deemed necessary, by the supervisor, job description or requirement.. Appropriate resources to perform daily functions either time, materials, equipment or people

• Has the process owner been identified? Each process owner is responsible or their training and processes/equipment, HR is the keeper of the records• What other staff members and/or suppliers are involved in the process? As assigned

• How does the company ensure training is effective? Each process or training has an appropriate measure of effectivity


The Head and Tail

INPUT

Customer wants?The customer is the owner of the process needing training or facility department with a resource need

Input RequirementsWhat are the inputs that determine what the process should produce? MR identifies a resource need, A CA/PA requiring resources

• Include any Customer/Internal/Governmental and Regulatory Requirements driven by MR of the

requirement. NA

OUTPUT

Customer gets?A trained, effective, efficient workforce with appropriate resources to economically and effectively perform its processes

Output Requirements

The identified needs are met

• What documentation is being created when this process is completed? Training, purchasing and

facilities records• Does this output create an input into another

process? Not directly, as and assist or enhancement/CI


Legs 3, 4MEASURE

(Recommend list 3.)

• What measuring tools are used to monitor the effectiveness of this

process? (Metrics, KOI's) # of employees trained/certified and the effective ness measure as appropriate.• How is continual improvement of this process ensured? Through periodic Management Review of resources. Through feedback from employees after formal training sessions...negative feedback is reviewed

HOWSupport Processes - Who helps and how? (Recommend list 4.)

• Have support processes been identified? Appropriate training • Have linkages to support processes, procedures and methods

been established? ALL QMS processes are linked through the QMS master list of proceduresProcedures/Control Documents

• Is this process properly documented? Training Records control is documented. Training procedure is documented.• What Work Instructions and/or Forms are affected by this Process? All Wi and forms• Are records appropriately stored and maintained? Yes


The PEAR

PEAR Intent/Purpose

• The PEAR was introduced to provide a tool that allows the auditor to systematically evaluate the effectiveness of a process based on the organizations method for monitoring and measuring their processes.


What is Effectiveness?• It is the extent to which planned activities are

realized and planned results are achieved

• (Reference ISO 9000 Quality management systems –Fundamentals and Vocabulary)


But Really What is Effectiveness?

In other words, is the process effective in:

• Fulfilling customer requirements?

• Delivering quality products, on time?

• Improving continually?

• Meeting established goals and objectives?

More than just a conformity assessment!


What will this Mean to the Auditor?

Review and examine an organization’s “Effectiveness” from:

– The customer viewpoint; satisfaction and performance.

– Organizational leadership goals and objectives.

– Alignment of process performance measures with quality objectives and customer requirements.

– Criteria used for deciding what data to analyze for determining process effectiveness.


General rules for use/application of a PEAR:

• At a minimum, the results of each audited product realization process, as determined by the organization (reference 9100-series clauses 4.1 and 7.1), shall be recorded on a PEAR.

• Each assessed process shall be recorded on a separate PEAR.

• There is no preset minimal number of PEAR’s required from an audit


General rules for use/application of a PEAR:

At a minimum, the results of each audited product realization process, as determined by

the organization (reference 9100-series clauses 4.1 and 7.1), shall be recorded on a PEAR.

Each assessed process shall be recorded on a separate PEAR.

There is no preset minimal number of PEAR’s required from an audit

To what level of detail does a process have to be to require a PEAR?

Consider what defines a process – inputs, outputs, process owners, etc.

If they are the same, then a higher level PEAR might be appropriate.

If they are not the same, then 2 separate PEARs should be created.

In determining the appropriate level reference the Form Instructions for the QMS Process Matrix Report (Appendix D) – it shows that Product Realization includes: Manufacturing-Machining, Manufacturing-Paint, Manufacturing – Assembly, etc.

When does a PEAR have to be done?

Reference quality manual & other QMS documentation for description and sequence of

interaction of processes

At a minimum, the results of each audited product realization process, as determined by

the organization (reference 9100-series clauses 4.1 and 7.1), shall be recorded on a PEAR

New Focus on Audit Planning in AS9101DThe AS9101D now requires substantial review of information/data in

preparing for audits.

Included in this data is the identification of processes including their interactions and sequencing.

The identification of these processes will then be used in preparing the audit plan/agenda and to identify the PEAR processes.

Process Based Audit Tool is an Input into the PEAR

The information that is recorded on the process based tool will then be an input for the

completing the PEAR later.

Process Based Audit Tool is an Input into the PEAR (cont.)

Collection of Data (4.3.2.2 of AS9101D) -

NOTE 1: The processes can be depicted in various ways [e.g., process maps, turtle diagrams, SIPOC method (breakdown of supplier, inputs, process steps/tasks,

outputs, customer), octopus].

AATT training -

Whatever audit tool is used, it should include process control methods for monitoring and measuring process effectiveness.

UL-DQS Inc. Aerospace Process Effectiveness

Assessment Report

Organization:

Site:

OIN:

PEAR Number:

Audit Report Number:

Issue Date:

Process Name:

Process details, including associated process interfaces:

Applicable 9100/9110/9120 clause(s):

Organization’s method for determining process effectiveness:

Auditor observations and comments supporting process effectiveness determination:

Statement of Effectiveness Level:

The process is:

1. Not implemented; planned results are not achieved. 2. Implemented; planned results are not achieved and appropriate actions not taken. 3. Implemented; planned results are not achieved, but appropriate actions being taken. 4. Implemented; planned results are achieved.

Auditor Name(s):

Auditee Representative Acknowledgement

Name:

Signature(s):

Signature(s):

Process Details/Interfaces

Process Details/InterfacesForm Completion Instructions from AS9101D - Summarize the process activities, inputs, and outputs; including the

identification of associated process interfaces.

Process Details/Interfaces –Example for Electronics Assembly Process

Process Details/Interfaces –Inputs into the process include traveler, BOM, pick list, work instructions, kitted assembly & MRP need date. Process flow is as follows: “Assemble per drawing – Tune & align unit – pre-

cap inspection – laser weld lid – environmental test – final test – paint & label – final inspect.” The outputs include completed assemblies and completed assembly records.

Process interfaces include production control, planning and engineering. Question: Is there something that could be added to this description of process

details/interfaces?Answer: The specific details of the process flow sequence alone does not highlight potential risk factors in meeting customer requirements and measureable objectives of the process.

Same Example, Different Write up Process Details/Interfaces –

Inputs into the process include kitted assembly and build paperwork & MRP need date. Process flow is as follows: “Assemble per drawing – Tune & align unit – pre-cap inspection –laser weld lid – environmental test – final test – paint & label – final inspect.” The nature of

the product developed and manufactured in the organization requires highly specialized and state of the art microwave/hybrid processes. The product itself can be very complex and on

occasion requires frequent design and development changes. The outputs includes completed assembly and assembly records. Process interfaces include production control,

planning and engineering. Question: Why is this process description better than the previous?

Answer: Because it highlights potential risk factors (product complexity, frequent design changes) in meeting customer requirements and measurable objectives of the process.


Assessment Report

Organization:

Site:

OIN:

PEAR Number:


Issue Date:

Process Name:






The process is:


Auditor Name(s):


Name:

Signature(s):

Signature(s):

Organizations method for determiningprocess effectiveness

Organizations method for determining process effectiveness

Form Completion Instructions from AS9101D - Describe the method used by the organization to determine process effectiveness [e.g., identification of Key Performance Indicators (KPIs) and associated

targets, process capability data].

Organizations method for determining process effectiveness –

Example for Electronic Assembly ProcessOrganizations method for determining process effectiveness -

Quality and on time delivery is tracked periodically.

Question: What is wrong with this description?Answer: Description is too brief and does not tell how quality is tracked (e.g., 1st pass

yield, RMA levels, scrap, etc.). It also does not tell how often quality and on time delivery is tracked and by whom.

Organizations method for determining process effectiveness

Same Example, Different Write up1st pass yields and on-time delivery is tracked daily and discussed during daily production

meetings with cross functional teams. This information is summarized and reported monthly by the quality manager to the general manager. The general manager will go over this

information on a quarterly basis with all employees during state of the company meetings.

Question – Why is this example better than the previous?

Answer – Because description is more thorough and describes how quality is tracked (1st

pass yields). It also mentions how often quality and on time delivery is tracked (daily production meetings, monthly reporting to GM and quarterly state of the company

meetings)


Assessment Report

Organization:

Site:

OIN:

PEAR Number:


Issue Date:

Process Name:






The process is:


Auditor Name(s):


Name:

Signature(s):

Signature(s):

Auditor observations & comments supportingprocess effectiveness determination

Auditor observations & comments supporting process effectiveness determination

Form Completion Instructions from AS9101D - Annotate relevant objective evidence, observed conditions, data,

information, comments, etc. to support the auditor's statement of effectiveness or ineffectiveness


Electronic Assembly Process ExampleAssessed 5 items through the assembly process. Work instructions were available for the

operator at stations in each of cells. Talked with 6 operators all who knew the quality policy. Records were available for review. All gauges had calibration stickers on them. Verified the training records for each of the employees interviewed and all had records of competence

for activity observed performing.Question: What is wrong with this description?

Answer: This description gives the evidence of compliance that was assessed. It does not address the effectiveness of the process. Based on this information the reader of the PEAR

would not be able to determine what Level the process is performing to.


Same Example, Different Write upOn time delivery target of 95% has not been met for the past 12 months. Average for past 3

months has been slightly below 75%. Factory is running at capacity according to Manufacturing Manager. Actions taken include hiring 2 new swing shift technicians and 7

new day shift technicians. Also, training of technicians of highly specialized processes is on-going. In addition, action is planned to automate some of the existing tuning and testing processes which should help improve delivery. Also, weekly material status meetings are

having a positive impact to schedule according to area manager. Question: Why is this better than the previous response?

Answer: This description tells of the performance of the process that was observed during the audit rather than identifying the evidence of conformance.


Assessment Report

Organization:

Site:

OIN:

PEAR Number:


Issue Date:

Process Name:






The process is:


Auditor Name(s):


Name:

Signature(s):

Signature(s):

Determining the appropriatelevel of effectiveness

New Levels of Effectiveness introduced in PEAR documents.

1) Process not implemented; planned results are not achieved?

2) Process implemented; planned results are not achieved and appropriate actions not taken?

3) Process implemented; planned results are not achieved, but appropriate actions being taken?

4) Process implemented; planned results are achieved?

Determining the appropriate level of effectiveness

Form Instructions –Indicate to what extent the audited process was determined effective.

Effectiveness: extent to which planned activities are realized and planned results achieved (reference ISO 9000).

NOTE 1: A major (ma) NCR shall be issued when the effectiveness level of the process is rated a "1".

NOTE 2: A major (ma) or minor (mi) NCR shall be issued when the effectiveness level of the process is rated a "2" (see nonconformity definitions

in clause 3).

Determining the appropriate level of effectiveness

What is written in the previous 2 sections should support this

determination.

In essence, the reader of the PEAR should already know what level the

process is performing at before looking at the checked box.

Example of Determining Effectiveness Level

Electronic Assembly Process

On time delivery target for electronic assembly process of 95% has not been met for the past 12 months. Average for past 3 months has been slightly below 75%. According to the Assembly Manager, the factory is running at

capacity but he has not been able to find new qualified technicians for hire required for some of its highly specialized processes. Performance data posted in the assembly area shows that electronic assembly has been running on over time for the past 9 months and 1st pass yield targets have not been met. RMA levels during this time frame have exceeded the goal of 1% or less for product

shipped and is currently at 3%.

What level of effectiveness would you assign?





Example of Determining Effectiveness Level

Electronic Assembly Process

On time delivery target of 95% has not been met for the past 12 months. Average for past 3 months has

been slightly below 75%. Factory is running at capacity according to Manufacturing Manager. Actions taken include hiring 2 new swing shift

technicians and 7 new day shift technicians. Also, training of technicians of highly specialized

processes is on-going. In addition, action is planned to automate some of the existing tuning and testing processes which should help improve delivery. Also,

weekly material status meetings are having a positive impact to schedule according to area

manager.

Example of Determining Effectiveness Level Electronic Assembly Process

On time delivery target of 95% has not been met for the past 12 months. Average for past 3 months has been slightly below 55%. Several key personnel

have left the organization since the last surveillance due to retirement and other reasons. Replacements have not been trained and there are no plans to have them trained until the next big contract is awarded. Furthermore, many of the assembly processes have not been documented and there seems to be

a dependence on tribal knowledge on how to get the job done. Several production travelers sampled contained operations that were not signed off

and had inspection operations that were by-passed. Customer complaints and RMA’s have tripled in the past 9 months.

Questions?

Barbara Butrym

Consultant & Instructor

The QPS Institute

225 Cedar Hill Street

Marlborough, MA 01752

Office: (508) 987-3800

Email: [email protected]

Henry Gamboa: UL DQS Aerospace Program ManagerMichelle Barton: UL DQS Senior Lead Assessor/Reviewer

Credits
