What should I know about ISO 9001? A standard for your long term success!
Introduction Welcome to:
What should I know about ISO 9001? Presenters: • Craig Cochran • Richie Ybarra - ISO Coordinator ReadyOne Industries • Ed Boerst - Corporate Quality Director Professional Contract Services, Inc.
Session Objectives • Provide an overview of the ISO 9001 Standard • Discuss the benefits and challenges of implementation • Provide examples from the CRP community • Reduce fear related to ISO implementation
Craig Cochran Business Coach
cochran@gatech.edu
A Management System‌
A systematic way to manage operations at all levels of the organization
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Key system components • Documented procedures • Defined responsibilities and authorities • Determination of resources • Clear processes and controls • Verification activities • Systematic improvement processes 6
What can we hope to gain from it? • Consistency of methods • Higher efficiency • Fewer mistakes • More involvement among personnel • Recognition by all customers
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But won’t it slow us down or limit our creativity?
No, it actually encourages creativity and efficiency by removing roadblocks
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What ISO 9001 is NOT • NOT an absolute standard • NOT confined to the quality department • NOT a “big honkin’ binder” of procedures • NOT additional bureaucracy
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ISO establishes standards for a vast range of endeavors ISO = isos = Greek word for “equal” ISO acronym
• More than 13,000 standards for business, government, and society • Military engineering • Agriculture • Image technology • You name it! 10
ISO 9000 Series ― What It Is • • • •
Generic, baseline series Widely applicable Defines the basics Identification varies among countries • U.S. => ANSI/ISO/ASQ Q9000 series
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ISO 9001:2008 The Requirements • • • • •
Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis, and Improvement
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“Shall” is the operative word in ISO 9001
Anywhere “shall” appears, the organization must do something
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The “Shalls� of ISO 9001 start in Section 4 and continue through Section 8 Materials outside of these sections are for guidance and illustration purposes only
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A confusing aspect of ISO 9001‌
The standard repeats itself numerous times
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The ISO 9001 standard is structured as a ‘process model’
The intent was to present the requirements in an integrated fashion, not in isolated buckets
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The Process Model Quality Management System CONTINUAL IMPROVEMENT
C u s t o m e r
Management Responsibility R e q u i r e m e n t s
Measurement, Analysis, Improvement
Resource Management
Input
S a t i s f a c t i o n
Product Realization
Output
Product
C u s t o m e r
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So, what do I need to know? 18
Quality Policy Things to know • Where it is • What it means • How you support it through your own activities
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Georgia Power Forestry Quality Policy Manage company rights-of-way in a cost effective manner, ensuring high reliability of service. In order to realize this mission, we are dedicated to the following goals:
• Target Zero – Every day, every job, safely • Right of Way management that meets all customer, stakeholder, and regulatory requirements
• Establish and implement objectives that drive behavior and continual improvement
• Ensure a reliable transmission and distribution system 20
Quality Objectives Things to know • What are the objectives • What they indicate • The current status of objectives…are they getting better or worse? • Specifically how YOU contribute to the achievement of objectives
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ACME Company – 2011 Business Objectives 1. Achieve a 98% on-time service rate 2. Reduce service re-work to 3% or less 3. Have 0 loss time safety incidents 4. Become ISO 9001 certified by December 2011
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Documentation & Procedures Things to know • How to access your documents • How you know documents are current • Understanding of contents • What to do if you had an idea for improvements • How documents are revised
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Leading documentation problems • Using an out-of-date document • Not realizing a document existed • Posting “bandit” documents, such as emails, memos, yellow sticky notes • Everybody just develops their own private documentation
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Control of Records Things to know • • • •
What records are you responsible for? Where are they located? How long are they maintained? Can your access appropriate records?
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Management Responsibility Things for Top Management to know • How do I communicate important topics to the organization? • How do I reinforce a customer focus? • How do employees learn about objectives and how they contribute? • How do I review our organizational effectiveness? • How do we receive customer feedback? • What actions are taken on customer feedback? 26
Management Responsibility Things for Top Management to know • How do employees learn of their responsibilities and authorities? • How was the management representative selected? • How do I ensure appropriate resources are determined and provided? • How do we address existing problems? (corrective action) • How do we address potential problems? (preventive action) • What is my leadership role with corrective and preventive actions? 27
Competency & Training Things to know • What jobs am I competent to perform? • What sorts of training events have I attended?
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Competency & Training Things for Human Resources to know • How do we document competency requirements? • Is the required education, training, skills, and experience addressed? • What training do we conduct to meet competency requirements? • What is the frequency of the training?
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Competency & Training Things for Human Resources to know • How do we evaluate training effectiveness? • What records are kept? • Is there a written training procedure? • How do we work to improve the training process?
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Example competency requirements Mail room specialist • Ability to demonstrate correct use of all mailroom equipment • Working knowledge of parcel service (USPS, UPS, FedEx) policies and pick-up times • Working knowledge of all internal mail room procedures; pass procedures quiz at 90% or better • Completion of training course “Suspicious Materials Handling” on a yearly basis • Completion of training course “Mail Privacy and Personal Conduct” on a yearly basis
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Infrastructure & Maintenance Things to know • What maintenance tasks am I responsible for? • How often are these tasks performed? • What records are generated? • Where are these records kept?
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Sales & Contract Things for Sales to know • How are orders and contracts received? • How are they reviewed? What is the record? • What happens if we don’t agree with order requirements? • What happens if problems arise after an order is accepted?
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Sales & Contract Things for Sales to know • How do we keep the customer apprised of progress on orders? • How is product information (brochures, website, etc.) kept up to date? • How do customers provide feedback? • How are complaints handled? • How is this information shared with the rest of the organization?
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Leading contracting problems • Customer changed requirements, but we didn’t communicate changes internally • Not formally reviewing requirements at the time of acceptance • Informal documentation of customer requirements • Accepting requirements we know we can’t meet
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Design & Development Things for Engineers to know • What constitutes the record of design planning? • How do we capture design inputs? • How do we generate design outputs? • What sorts of design review are performed? What are the records?
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Design & Development Things for Engineers to know • What design verifications are performed? What are the records? • What design validations are performed? What are the records? • How do we change existing designs? What are the records?
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Purchasing & Supplier Management Things for Purchasing to know • What is our criteria for selecting, evaluating, and re-evaluating suppliers? • What records do we have of evaluating suppliers? • Are ALL critical suppliers included within the system? • What happens to suppliers who fail to perform? • How do we communicate requirements to suppliers? • How is purchased product verified when it arrives? 38
Leading purchasing problems • Evaluating suppliers with meaningless criteria • Not clearly documenting purchase requirements • Not requiring suppliers to take corrective action when they fail
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Process Control Things to know • How you monitor your process • What specifications or standards are in place • What written procedures apply to your process? • What tools and equipment are required for your process?
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Process Control Things to know • What are the acceptable limits of your process? • What do you do if the process exceeds these limits? • How would you propose improvements to your process? • Who are the customers of your process and what are their requirements?
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Leading problems with process control • No oversight or supervision • Putting people on the job before they understand the tasks • No clear guidelines for acceptable versus unacceptable process results
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Material control & product Preservation Things to know • How products are coded and labeled • Correct locations for products, based on their status • Preservation requirements • What to do when products lack identification • Special handing and storage requirements, if any
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Repair & customer property Things to know • How is customer property identified? • How is it protected and safeguarded? • How do we know what to do with it? • Who do we notify if customer property is unsuitable or can’t be repaired? • What records are kept?
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Calibration Things to know • • • • •
The measuring instruments under your control Correct method for using measuring instruments Who do I notify when calibration is due? Status of calibration What you would do if measuring instruments malfunction
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Customer Satisfaction Things to know • Your customers and their requirements • How we capture feedback • How feedback is analyzed • What actions are taken
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Monitoring & measurement of product Things to know • What is the criteria for product inspection and test? • What is the frequency? • What records must be generated? • Are you required to record any special data about inspections and tests? • What happens if product does not meet requirements? 47
Leading inspection problems • Getting into a hurry and skipping it • Using the wrong inspection criteria • Not keeping records • Tying inspection results to disciplinary action • Separating the making from the checking 48
Control of Nonconforming Products Things to know • How nonconforming products are identified • Where they are stored • Who dispositions them • Your role in carrying out the disposition • What records must be kept
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Leading problems with nonconforming products • Assuming that people know what nonconforming looks like • Removing nonconforming identification before disposition is complete • Allowing nonconforming products to get out the door 50
Internal Auditing Things for auditors to know • Do you have a procedure for internal auditing? • Where is our schedule for internal audits? • How are audits planned? • How are auditees notified? • How do you plan your interview questions and audit trails? • Do you look for positives?
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Internal Auditing Things for auditors to know • How do you handle audit nonconformities? • How do you sample evidence? • What do you do when disagreements arise? • What records are created by the audit process? • What is your role in verifying corrective actions? • What sort of training qualifies you to be an internal auditor?
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Continual Improvement Things to know • What are some of our key tools for driving improvement? • How can I get involved? • What do I do if I have ideas for improvement?
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Corrective / Preventive Action Things to know • Method for initiating corrective or preventive action • What sorts of issues can trigger corrective or preventive actions • How are causes determined? • How do we ensure actions are taken? • Status of corrective and preventive actions in your area 54
Leading problems with corrective actions • “Pencil whipping” corrective actions • Taking action on symptoms instead of causes • Not digging deep enough to identify real causes • Closing corrective actions before there is evidence of effectiveness 55
The Implementation Process
ISO 9001 implementation success factors • Getting some expert assistance right at the beginning • ISO 9001 Gap Analysis • ISO 9001 Project Planning, with clear action items • Visibility of progress against action items • Broad involvement of many personnel – not a single person’s project 57
ISO 9001 implementation success factors • Top management closely involved • Not having a “Let’s get a certificate on the wall” philosophy • Training a diverse team of internal auditors • All focusing failures on the process, not on people
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The Certification Process 59
What do we need to do to become ISO certified? •
Successfully complete an audit by a registrar
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The audit will occur after we have set up processes to meet all the requirements of the standard
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Auditors will determine if the processes meet the requirements of the standard, and see if we are following them
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About the audit • It is important to remember that no one is being audited on their individual performance! • The audit will evaluate the performance of the organization as a whole • The intent of auditing is not to nit-pick, but to drive meaningful improvements
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What role will you have in ISO? • Our processes will be controlled by the use of work instructions, training employees, and other methods • Employees will be required to follow work instructions for certain jobs • Employees also need to be aware of how their job affects the plant’s objectives
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ISO 9001:2008 How Do You Maintain Certification? • Pass surveillance audits, usually a partial audit every 6 months • Pass re-registration audits, usually a full audit every 3 years
NOTE: Systems vary among registrars. 63
Don’t miss this Course! • “Attaining Customer Loyalty” September 13-14, 2011 Las Vegas, NV • Fun, interactive, and practical • Offered at NO COST to NISH affiliate organizations • Register: https://www.nishacademy.org • Or contact Cora Chaply at: 571-226-4534
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For more information:
Presenter: Craig Cochran 678-699-1690 craig.cochran@innovate.gatech.edu
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Smart and practical books :
www.patonprofessional.com 66
Management Reviews Measuring the Effectiveness of an Organization Richie Ybarra - ISO Coordinator ReadyOne Industries
rybarra@readyone.org 67
Management Reviews Performance Inputs – Measuring Objectives
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Management Reviews Performance Outputs – Establishing Improvements
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Management Reviews Validation of Improvement Efforts – Added Value?
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Management Reviews Performance Management – Business Goals for ROI
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Management Reviews Control of Records – Power of Documentation
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Ed Boerst - Corporate Quality Director Professional Contract Services, Inc.
INTRODUCING PCSI At PCSI, we take pride in the quality and performance of the service we give to our customers and the diverse employment opportunities we provide for people with disabilities.
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HISTORY PCSI started in a one room office with 2 employees. When: Founded 1996, with 2 employees Why: To provide employment opportunities for people with disabilities through performance of state and federal contracts What: Ability One; formally Javits-Wagner-O’Day (JWOD) Program, Texas State Use Program (TIBH) – turnkey contract management solution How: Operates as a business, completely self-sufficient contractor Where: Corporate Headquarters – Austin; contracts located in 6 states – TX, OK, CO, UT, VA and WA
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PCSI HIGHLIGHTS Average annual growth since 1996 = 20% Strongest growth potential – Hospital Housekeeping, Facilities Maintenance, Vehicle Maintenance, Warehouse Operations and Data Entry Currently have approx. 40 contracts with over 1250 employees ISO Certification received in December 2007 Recertification received in December 2010 Currently have 10 contracts certified at 6 sites plus corporate. Will add 2 contracts at 2 sites in May and June of this year. 76
WHAT ISO BROUGHT TO PCSI ISO implementation and certification brought consistency among sites: • Concept that all provided services are process based •
Processes were captured and documentation developed to standardize processes among sites
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Resulted in common formats for procedures, records, and forms
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Standardization of documentation numbering at the site and corporate levels
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Document Control (all documents recorded on a Master Document List)
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Developed universal methods for sites to perform audit inspections and report quality performance, on a monthly basis, to PCSI Corporate Management
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WHAT ISO BROUGHT TO PCSI ISO fostered a continuous improvement cycle: • Improvement of Input + process improvement = • Reduction in customer complaints • Significant reduction in deficiencies per site • Improved site AQLs • Reduction in cost • Total customer satisfaction Praeto analysis was implemented to analyze and trend deficiencies to provide correction and eliminate recurrence. Formal “closed loop” Corrective Action and Preventive Action processes were implemented at all sites. 78
Discussion & Questions What should I know about ISO 9001?
POLLY WESSEL Senior Quality Manager NISH - Products 8401 Old Courthouse Rd. Vienna, VA. 22182 office: 703-584-3956 pwessel@nish.org
Session Evaluation Information
SESSION TITLE: Tools1 SESSION CODE: Q-T900