Minden Orientation To Iso[1]

ISO 9001:2008QUALITY

MANAGEMENTSYSTEM

PRESENTED BY:

Wendy Stein, International Contract Compliance Auditor

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QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)

QUALITY – Degree to which a set of inherent characteristics fulfils requirements*

– *ANSI/ISO/ASQ Q9000-2008

Level to which the existing quality system satisfies our customer’s requirements

The ability of a product or service to meet or exceed customer expectations

What is QUALITY?

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QUALITY ASSURANCE – The part of Quality Management that focuses on providing confidence that quality requirements will be fulfilled

QUALITY CONTROL – The part of Quality Management that focuses on fulfilling quality requirements*


Quality Assurance vs. Quality Control

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PROACTIVE – PLANNING

PREVENTATIVE IN NATURE WHERE DEFECTS AND/OR DEFICIENCIES ARE CONCERNED

PROVIDES FOR CUSTOMER SATISFACTION

PROVIDES FOR INSPECTION & MEASUREMENT

AIMED AT DETECTING DEFECTS

IS A MEASURE OF THE SUCCESS OF QUALITY ASSURANCE (QA)


QA QC

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Ensure YOUR Work is Accurate

Verify the Work of Your Co-Workers – ASK SOMEONE TO CHECK YOUR WORK TOO!

Do Not Accept Deviations from ESTABLISHED Written Procedures Without Communication – AND APPROVAL


What are Your Responsibilities?

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Can We Apply the ISO Standard to Our Business?


The standards originated in manufacturing process

Now they are employed across several types of organizations

A "product", in ISO vocabulary, can mean a physical object, OR a service

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ISO – INTERNATIONAL STANDARDIZATION ORGANIZATION

9001-2008 - The latest revision to the Quality Management System Standard


What is ISO 9001-2008?

http://www.ansi.org/

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A SYSTEMATIC approach to QM which emphasizes the importance of:

Identification of Requirements, Understanding them and Meeting Our Goals

The Need to Consider Processes in Terms of “IS THIS VALUE ADDED?”



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Obtaining the Results of Process Performance & Effectiveness and Analyzing Your Findings (ROOT CAUSE)

Continual Improvement of Processes Based on Objective Measurement & Evidence

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QUALITY MANUAL – Written, Endorsed and Driven by the Management of SOC Minden that will state how we will achieve our business and quality goals & objectives.

Quality Management IS NOT SEPARATE FROM General Management – Quality Management SHOULD be an integral part of our organizations overall management approach


ISO 9001-2008 ELEMENTS

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SOC team members are committed to achieving and maintaining Total Customer Satisfaction by supplying the highest quality services, while

maintaining commitment to our core values.

Our success as an enterprise is a direct reflection of the promises we keep to our customers and their respect for SOC. We must first keep our promises to one another and demonstrate mutual respect to fellow team

members, supply partners, and our customers.

We willingly accept the responsibility of leadership to achieve our quality goals, which will be reached through innovation, education, teamwork,

and the desire for continuous improvement.


Quality Policy

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CONTROL OF DOCUMENTS


Includes both internally produced and externally obtained documents

Controlling Documents ensures we utilize only current business practices and/or customer requirements


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CONTROL OF RECORDS


Ensure Current Forms are Used

Ensure the SAME Forms is Used

Completed Forms become Records and are Retained to Provide Objective Evidence to the Customer – We are in fact doing what we say we are doing

Provides for objective evidence to ensure conformance to the standard

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FORM NUMBER TITLE OWNER

E-1 Letter of Authorization Operations

E-2 Travel Profile Human Resources

E-3 Expense Reimbursement Request Financial Management

CONTROL OF RECORDS

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The Difference Between a Document & a Record

A Document will change and evolve to reflect our current business practices

A Record does not change and is a history of our past business practices

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Both can and should be used to perform documented quality and performance trends

Compare our data to competitors’’ data and/or quality benchmarks

Both can be used to solve customer related problems & issues

Both support status reviews, decision making and long term planning initiatives

The SIMILARITIES between Documents & Records

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CONTROL OF NON-CONFORMING PRODUCT/SERVICE – How do we react and intervene when our process doesn’t meet our own requirements or the requirements of the customer


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INTERNAL AUDITING & SELF ASSESSMENT – Looking into the way we conduct business from the inside, analyzing our processes to ensure we are doing things


EFFECTIVELY!EFFICIENTLY!& THE WAY WE

SAID WE WOULD


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Ask Yourself & Others – “WHAT CAN GO WRONG?”


Then Write Your Process Plan (PROCEDURES) Accordingly

PROCESS DEVELOPMENT

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PROCESS DEVELOPMENT1. IDENTIFY YOUR PROCESSES

2. INVOLVE ALL OF THE STAKEHOLDERS IN DEVELOPMENT

3. DOCUMENT YOUR PROCESSES

4. LISTEN TO YOUR CUSTOMERS AND IMPLEMENT CORRECTIVE &/OR PREVENTATIVE MEASURES ACCORDINGLY

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CorrectiveAction

Implementation

CorrectiveAction

Implementation

ANALYZE ACTION FOR EFFECTIVENESS

ANALYZE ACTION FOR EFFECTIVENESS

Machineor

Human Error

Machineor

Human Error

CAUSE• Error Detection• Deviation from

Established Procedures

• Error Detection• Deviation from

Established Procedures

INTERMEDIATE RESULT

ZERODEFECT

ZERODEFECT

END RESULT

MODIFY/CHANGE PROCEDURES FOR PREVENTATIVE ACTION

MODIFY/CHANGE PROCEDURES FOR PREVENTATIVE ACTION

WorkProcedure

WorkProcedure

PROCESS DEVELOPMENT

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The design is too complex – too many parts (KISS METHOD)

The design is inadequate – Not enough direction in the written standards

The process does not flow logically

Too much repetition and/or too many adjustments

Critical mission essential information is left out

YOU do not know ENOUGH about the process in and of it’s self for a process you are attempting to document – call in the SME!!


ERROR PROVOKING SITUATIONS

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Question the Individuals involved in performing the actual work - then document the process accordingly

Keep in mind adjustments may need to be made to ensure compliance to customer/client requirements – BUT BE FLEXIBLE & CREATIVE in your problem solving – BUT BE SURE TO INCLUDE ALL OF THE PLAYERS.

ERROR DEFECT

Cause

Result


AVOIDING THE PITFALLS

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Prevention of Defects

Customer Satisfaction

Enhanced Process

Reliability

Customer Confidence

Reduction in Wasted Effort

Process Ownership

Pride, Confidence and Personal Satisfaction

Procedural and Regulatory Compliance

Global Recognition

Benchmark Performance

Standards


ProductivityProcess

Consistency

WHAT DOES QUALITY MANAGEMENT MEAN?

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• The Scope of Our Registration – Tells Our Customers Exactly What We are Good, GREAT at doing

WHAT IS THE SCOPE OF REGISTRATION?


Technology

Minden Orientation To Iso[1]