THE PROCESS APPROACH - ASQ Binghamton, NY Section · 2019-02-27 · 13 THE PROCESS APPROACH JDT – February 21, 2019 - Master QMR Quality Management Resources ISO 9001 In A Nutshell…

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THE PROCESS APPROACH

JDT – February 21, 2019 - Master

QMR

Quality Management Resources

ISO 9001:2015 &

The Process Approach To

Quality System Management

Jim Tregaskis Certified Lead Auditor


Endicott, New York

[email protected]

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Presenter Background

• 1964 >1993 > IBM Endicott Manufacturing – Quality Assurance

- Quality Lab - Machining Operations – Printer Manufacturing – Bank Systems

- Technology Manufacturing – Process or Systems – Procurement Engineering

– Manufacturing Engineering – Product Operations Quality Coordinator

- 1989 - 1991 > ISO Management Representative For IBM Product Plant

- 1991 - 1993 > IBM Endicott Site Quality Office

- Business Process Improvement

• 1994 - 1996 > “Global Systems” Training & Consulting

• 1996 - Present > DBA “Quality Management Resources”

- ISO 9000 Training and Consulting

- Quality System Lead Auditor

- Bureau Veritas Certification(NA)

Certified

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Contents…

• What is ISO 9001?

• Continual Improvement

• The “Process Approach”

• System Management & Auditing

• Continue Improvement

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At the Conclusion Of This Presentation,

Attendees Should…

- Obtain A General Understanding Of ISO 9001,

The International Standard For Quality Management Systems

- Understand the Concept Of

“Continual Improvement”

- Develop An Appreciation

For The “Process Approach”

As A Methodology For Continual

Quality/Business System

Improvement

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The ISO 9001 Standard… Establishes The Requirements For A Quality (Business?) Management System And An Approach For Continually Enhancing The Effectiveness Of The Management System To Improve Customer Satisfaction By Meeting Customer Requirements

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What Is a System?

Can You Name Some?

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A System is…

- A Whole Formed of Related Things

- A Set Of Organized Facts, Things

- An Orderly Way of Doing Things

In The “World Of ISO”… - A Set Of “Activities” or “Processes”

Intended to Perform Work

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So….

We Can Think of a Management System

As a Series of Processes…

We Can Also Think of a System as a Chain

Made Up of a

Series of Links…

or Processes

https://en.wikipedia.org/wiki/File:Broad_chain_closeup.jpg

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Stop…. Think About It

A Chain Is No Stronger

Than Its Weakest Link

A Management System

Is No Stronger Than Its Weakest Process

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Concept….

A (Management) System,

Therefore, May Be No Stronger

(Effective & Efficient)

Than Its Weakest Process

The ISO Standard Requires Organizations To Continually Improve Every Process In Order to Make the Overall System As Effective and Efficient as Possible

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An Overview Of The ISO 9001:2015 Standard

• Introduction • 1. Scope • 2. Normative References • 3. Terms and Definitions • 4. Context of the Organization – Interested Parties – QMS Scope – QMS Processes – Process Approach • 5. Leadership • 6. Planning – Planning for Risk & Opportunities

• 7. Support – Resources – People – Competence – Communications – Awareness – Documented Information • 8. Operations – Purchasing – Sales & Marketing – Product & Service Development

– Production – Control of Changes – Control of Nonconformance • 9. Performance Evaluation – Management Review – Customer Satisfaction – Internal Audits – Corrective Action

• 10. Improvement – Continual Improvement

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Overall Theme…

Continual Improvement

Dr. Edward Deming

Father of Continual Improvement

A Never Ending Approach For Improving Product And Process Performance

START

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ISO 9001 In A Nutshell…

The Standard Encourages Every Part Of The Organization

To Participate In Continual Improvement Activities By

Monitoring And Measuring Products, Services, And Processes;

By Analyzing Information To Identify And Take Action;

All With The Intent Of Improving Organizational Effectiveness

And Efficiency And Improve Customer Satisfaction

Improving Customer Satisfaction

Should Result In Better

Business Performance

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What’s the Best Way To Eat an Elephant?

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What’s the Best Way To Eat an Elephant?

One Bite At A Time

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Likewise…

The Most Effective Way To Improve The Quality/

Business Management System Is To Do It On A Process By Process Approach

In Small Pieces (Every Process)

~~ Better Yet… All “Processes”

Continuously At The Same Time

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What Does The Standard Require?

4.4 Quality Management System and its Processes 4.4.1

• The organization shall determine the processes needed for the management

system and their application throughout the organization, and shall:

a) determine the inputs and outputs (interactions),

b) the sequence and interactions,

c) monitor, measure to ensure effective operation and control,

d) determine and ensure availability of resources,

e) assign responsibilities and authorities,

f) address risks and opportunities,

g) evaluate and implement changes to achieve their intended results,

h) improve the processes and the quality management system

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A Process…

Uses Resources to Convert inputs into outputs

Input (Customer

Needs)

Process Outputs (Customer Needs

Satisfied)

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Can You Name Some Processes?

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• Management (Leadership) Process

• Administrative Process

• Sales/Marketing

• Quotation and Order Review

• Product Design & Development

• Scheduling

• Product Manufacturing

• Service Delivery

• Packaging and Delivery

• Quality Process

• Equipment Maintenance

• Human Resources

• Invoicing/Payment

• Warranty/Service

• Customer Feedback

• Information Technology

How About A Continual Improvement Process??? ~ Corrective Action ~ Preventive Actions ~ Improvement Projects ~ Internal Audits ~ Management Review

Typical Businesses Processes

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~ Processes ~ Sequence & Interactions

Process

A

Process

D

Process

B

Process

C

Input Output Controls

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So….. How Can One Improve A Process?

• First Step Understand The Process - Sequence - Interactions - Tasks or Activities - Input(s) - Output(s) - Intended Results - Objectives

- Measurements

- Resources - Controls

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How Can You Describe A “Process”?

• Flow Diagrams

• SIPOC Diagrams

• Procedures

• Work Instructions

• Recipes

• Pictures

• Check Sheets

• Job Orders

• Production Routers

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How Can You Describe A “Process”?

• Flow Diagrams

• SIPOC Diagrams

• Procedures

• Work Instructions

• Recipes

• Pictures

• Check Sheets

• Job Orders

• Production Routers

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The “Turtle Diagram”

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Process: Sales – Quote – Order Processing Process

Owner: Customer Service Representatives (CSR’s) Process Description This process is responsible for identifying the requirements for customer designed products which will have “value added” processes performed by Acme Industries, Inc. based upon a customer purchase order (contract). The value add may be partial or “build complete.” Customer Service Representatives (CSR’s) are responsible for communicating with customers to determine product requirements. They are then responsible for entering requirements into the JobBoss quote module to create an initial Production Traveler and develop the estimated cost. A Quote Response is sent to the requesting customer. Upon receipt of a Customer Purchase Order or contract, the order is reviewed against the original JobBoss quotation. The CSR is responsible for obtaining any missing requirements, clarifying requirements and resolving any conflict of requirements from the quote. Capacity and capability to meet the customer requirements are verified and the order accepted (or rejected). The customer is notified of order acceptance, the leadtime and any additional requirements. Orders may be for: - New products (including prototype, sample, and first-time orders) - Modifications of existing, similar products - Verification of price and delivery

Outputs •Product pricing, leadtimes

•Production Traveler (Router)

•Quote Response

•Approved Orders

•Production Work Order

•Order Acknowledgement

•Records (IOP 4.2-2)

Physical Resources (With What?)

• JobBoss System

Human Resources (With Whom?)

• Customer Service Representatives • President

• Production Department Managers

Work Activities Quotation Processing •Customer Service Representatives (CSR’s) contact customers for leads (or) the customer contacts the CSR’s directly with a Request for Quote (RFQ) by mail, phone, e-mail or fax •CSR enters request into the Quote Entry function in JobBoss to create pricing & quote •CSR reviews product requirements, requests any missing information - Customer drawings, specifications, requirements not known by the customer but necessary, statutory & regulatory reqmt’s or those determined needed by Acme •For “general machining” a decision made by the CSR to proceed with a quote as a business opportunity or by the President for “compaction tooling.” •CSR creates initial Traveler and develops cost estimate using JobBoss; including tooling •CSR reviews, approves, signs and sends Quote Response letter for general machining. - For “compaction tools” the quotes are reviewed by the President to establish pricing. President signs the Quote Response letter as evidence of approval. Order Review and Processing •Office receives customer order and assign Acme Job Number from Job Book - If new customer, verify stability and credit rating •CSR determines if there are any “special processes” (7.5.2) or quality requirements •CSR reviews the order requirements against the current quote and resolves any differences - Record of review is evident by signature of CSR on customer P.O. with Job #) •CSR verifies capability, capacity, tooling, machines, manpower, and resources needed •CSR finalizes Traveler and places supplier Purchase Orders for materials/parts per PM-03 •QA defines 1st piece, in-process, final verification requirements (if required) per PM-08 •Order Acknowledgement sent to customer, if requested

Controls (How? Methods, Procedures, Etc.

•JobBoss quote and order processing controls

•Order Book (Active and Closed status)

Measurers Effectiveness: •Workload •Customer Satisfaction Efficiency: •Quote to Order Win Ratio

Inputs •Request for Quote

•Customer Requirements, including

Product Drawings, Specifications,

Quantity, Delivery, and Special

Requirements

- Packaging, Quality, etc.

•Customer Purchase Order or Contract

•JobBoss history (if available)

NOTE: •Verbal and telephone orders will be

handled the same way but must always

have an Order Acknowledgement sent to

the customer followed later by a formal

purchase order from the customer

PM-09

PM-02

Revision: 04-10-07

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Process: Production Process

Owner: Production Department Managers

Process Description This process is responsible for the production of machined and compaction tooled products to meet customer specifications. It includes manual and CNC milling, turning and

grinding operations. Each of these machining centers has its own Production Department Supervisor who provides support to the Customer Service Representatives. Certain products

may require light assembly. Operations such as heat treat, plating, finish painting and protective coating are outsourced. (See PM-03) Operation set-up is performed by Set-Up

Operators before the job is turned over to a qualified operator. The process includes all shop floor control activities including assuring that all applicable Job Package documentation

is available. The generation of CNC machine control programs, their maintenance, and control is also part of the Production Process and performed by trained employees.

Inputs •JobBoss Information

- Job Order

- Production Traveler

- Scheduling Report

•Raw materials, parts, tooling

and supplies (From PM-03)

•Outsourced Product Content per

PM-03, Material Control Process

Outputs •Completed Product for

Shipment

•Nonconforming Product

for Disposition

•Production Records

- Signed Traveler

- Inspection Results

- JobBoss Transactions

Physical Resources (With What?) • Manual Machine Tools •CNC Machining Centers •Tools, Fixtures •Inspection & Test Equipment •Raw Materials, Parts

Human Resources (With Whom?) •Production Department Supervisors •Set-Up Operators •Operators

Work Activities •Customer Service Representative creates a Work Order Package consisting of customer drawings, JobBoss Production Traveler, and any other documentation. - The part revision level is verified against the Customer P.O. •Work with Production Department Supervisors to review production capability and capacity, including availability of materials, machines and personnel and release, schedule and prioritize jobs. Assign jobs to Production Operators •Collect/obtain necessary raw materials, parts, fixtures, tools and equipment •Complete job set up by Set-Up Operator, Foreman or Supervisor & verify results •Obtain First Piece Inspection per PM-08, Quality Process - Proceed with production if acceptable / correct if rejected •Production Department Supervisor or Set-Up Operator reviews job with assigned Operator •Operator runs production per Work Order Package Documentation and Traveler •Track Production Work Order status and ensure labor reporting data is entered into JobBoss •Operator performs In-Process Inspections per Production Traveler and/or the In-Process Inspection Plan and Record per PM-08, Quality Process •Operator records any scrap, tags and segregates nonconforming parts per IOP 8.3-1 •Operator records production quality and time in JobBoss. Note: The Traveler is NOT required to be signed showing completion of operations. Status is shown by way of the Part ID Tag and JobBoss •Parts identification and traceability is maintained per the Production Traveler and through the use of the Part ID Tag •If required by the Traveler, the completed product is submitted to QA for final inspection per PM-08 •Product proceeds to next operation, as required by the Traveler

Controls (How? Methods, Procedures, Techniques •Work Order Package including Production Traveler •JobBoss Scheduling and Status Reports •PM-08, Quality Process •IOP 8.3-1, Control of Nonconforming Material

Measurers Effectiveness: •On-Time Product Delivery •Product Quality •Nonconforming Product (NC’s) •Efficiency: •Operation Efficiency (Actual Time/Cost vs. Estimate) •Job cost Analysis (Margin)

PM-09

C

U

S

T

O

M

E

R

PM-03

Packaging

Revision: 4-10-07

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Process: Quality Process

Owner: Quality Assurance Manager

Process Description This process is responsible for the inspection, test and acceptance of product. Acme Industries, Inc. practices “built-in quality.” Personnel are responsible for the quality of their work. The process establishes requirements associated with First Piece Inspection, In-Process Inspection, and Final Inspection or Test Verification It includes the Control of Nonconforming Material and the Control of Monitoring and Measurement Equipment. This process also ensures appropriate monitoring and measurement of both product conformance and process performance.

Inputs •Incoming Material and Product

to Verify

•Production Parts for

Verification

•Nonconforming Material

Reject Notification

•Equipment for Calibration

Output •Calibrated Equipment

Physical Resources (With What?) •JobBoss •ProGage ISO Control System •Inspection and Test Equipment •NIST Traceable Standards

Human Resources (With Whom?)

•Quality Assurance Manager

•Receiving/Shipping Personnel

Work Activities Control of Monitoring & Measurement Equipment •QA Manager maintains list of equipment requiring calibration using the ProGage ISO control software. QA schedules, performs calibration of gages using NIST traceable standards or arranges for ISO certified calibration services, as needed. •Initiates assessment of product processed on equipment subsequently found out of calibration and maintains records in ProGage ISO. •Updates, maintains and adjusts calibration frequency based on history •Labels equipment and maintains records. First Piece Inspections •For first run parts, a 1st piece verification is done by QA Manager, Set-Up Operator, the QA Inspector or Department Supervisor. A First Piece Inspection Record is completed and provides accept/reject disposition. (See also PM-03, Material Control Process for new suppliers)

-The record is signed/dated as authorization of acceptance/rejection. -If the part is rejected, the equipment/processes is adjusted and another sample is submitted for inspection. This is repeated until approved.

•For repeat parts, a 1st piece verification is optional at the discretion of the QA Manager or if required by the Traveler. In-Process Verification •Operators are responsible for their quality by operation. Sample size and frequency are defined by the In-Process Inspection Plan and Record. Actual results are recorded. Final Verification (Including any required testing) •Since each operation is verified, final verification by QA is only when required by the Traveler or at the discretion of the QA Manager. Results are recorded on the Final Inspection Plan and Record.. The CSR (or other JobBoss authorized personnel) verify inspection records and are responsible for final release of product as evident by the creation of a JobBoss Packing Slip. Control of Nonconforming Material •Nonconforming product/material will be properly tagged and segregated to avoid unintended use per IOP 8.3-1. •The QA Manager disposes of NC material after review, if necessary, with the CSR and/or Department Supervisors per IOP 8.3-1, Control of NC Product. Monitoring and Measurement of Product and Processes •Product monitoring and measurement will be as described above •Product information is the primary data used to monitor and measure process performance. (See PM-12, Continual Improvement Process)

Controls (How? Methods, Procedures,

Techniques

•JobBoss Control System

•ProGage Calibration System

•Procedure IOP-8.3-1, Control

of Nonconforming Material

•First Piece Inspection Record

•In-Process Inspection Plan &

Record

•Final Inspection Plan &

Record

Measurers

Effectiveness: •Zero Past Due Calibrations •Quality Tool Kit - Supplier, Customer, In-Process Rejects (NC’s) Efficiency: •QA Backlog

PM-08

Output •Accepted Incoming

Product

Outputs •Properly controlled and

disposed noncon-

forming product

Outputs •Accepted Out-going

Product

PM-09

PM-09

PM-09

Customer

Note:

Incoming Product and

Outsource Verification of

incoming product and

services is done per PM-03,

Material Control Process

Revision: 4-10-07

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After We Define The Processes Their Sequence & Their Interactions

To Each Other…

We Need To Describe The Relationships

Between Individual Requirements

Of The ISO 9001 Standard And

Each Processes

How Can We Do This?

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Processes

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Example Completed “Process Audit Matrix” Note The “X”s and

“XX”s “XX” = Primary Relationship “X” = Secondary Relationship

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Now… One Can Start To Improve The Processes

Measure

Objectives

Implement

Improve

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The “Process Approach” Encourages You To Optimize Available Time And Resources By Establishing Priorities And Frequency Of The Processes To Be Audited Based On “Status and Importance” And Considering Past History

Improving The Processes • Monitoring and Measuring • Analyzing Data and Information • Identifying Problem Areas - Performance Objectives Not Being Met - Trends - Repeat Problems

• Prioritizing Actions • Taking Corrective Action • Identifying Improvement Projects • Verifying The Effectiveness Of Actions Taken • Applying the “Continual Improvement Model”

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Audits Are An Important Improvement

Tool

Matt & John

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Establishing An Audit Plan Based On The Process Matrix

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Strategic Policy Deployment

2018 Strategic Plan

Senior Management Team Revised 11/1/2018

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Can You Name Some Tools (Methods) That Can Be used to Improve A Process?

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Some Tools For Continual Improvement….

• Process Mapping “As Is” Process - “To Be” Process

• LEAN Projects • 5-S Program 5S Pillars: Sort - Set in Order - Shine - Standardize - Sustain

• Kaizen Events • DMAIC Problem Solving Define - Measure - Analyze - Improve – Control

• 8-D Problem Solving Form Team - Describe Problem - Immediate Action

- Root Cause Analysis - Plan Corrective Action

- Implement Corrective Action - Preventive Action

- Team Recognition

Others…?

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Pulp Bleaching Process

Engineers put controls in

place to maintain process

settings that greatly reduce

the chance of the process

drifting out of control.

The successful process

improvement can be seen an

Individuals Chart with

Stages.

Solution: What causes an out-of-control

process?

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What is the skillset of these resources? To collaborate and problem solve with individuals or

functional process improvement teams.

To understand the process needs of the components and to develop and deploy analytics and solutions that will improve the effectiveness and efficiency, regardless of industry or organization.

The framework for driving improvement is crucial

As is true for all problem solving initiatives, teams benefit from structured methodology

CRISP-DM

DMAIC

SEMMA

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A Reminder…

ISO 9001 In A Nutshell:

The Standard Encourages Every Part Of The Organization

To Participate In Continual Improvement Activities By

Monitoring And Measuring Products, Services, And Processes;

By Analyzing Information To Identify And Take Action;

All With The Intent Of Improving Organizational Effectiveness

And Efficiency And Improving Customer Satisfaction

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Thank You…

Questions?

Documents

THE PROCESS APPROACH - ASQ Binghamton, NY Section · 2019-02-27 · 13 THE PROCESS APPROACH JDT – February 21, 2019 - Master QMR Quality Management Resources ISO 9001 In A Nutshell…