Introduction to ISO & The Quality Process
Revision A Developed 9-16-13
ISO 9001:2008 Certification What does it mean? ISO (International Standards Organization) Certification is being required by more and more customers as proof that our company delivers quality products. In simple terms, it means one thing: Say what we do Do what we say
Introduction to ISO 9001:2008 The ISO 9001:2008 Standard is an International Standard that specifies requirements for a Quality Management System where an organization meets two criteria: 1. Demonstrates its ability to consistently provide product that meets customer and applicable regulatory requirements 2. Aims to enhance customer satisfaction through the effective application of the system, including processes for the continual improvement of the system and assurance of conformity to customer and applicable requirements Certification to an ISO 9001 Standard does not guarantee the quality of end products and services; rather, it certifies that consistent business processes are being applied
Quality Management System Mission Statement A full service provider of electronic repair, test and intelligent inventory management I 2 M solutions.
Standard consists of 8 Elements 0-3 are introductory and administrative 4 5 6 8 7
ISO Broken Down 4 Quality management system 4.1 General requirements: Say what you do - Do what you say Prove It 4.2 Documentation requirements: Write down the important things Quality Manual Make directions available to the users Identify needed records and keep them up to date Quality Manual Procedures Instructions Records & Documents
ISO Broken Down 5 Management Responsibility 5.3 Define your Quality Policy RVI is committed to providing quality services and products to meet and exceed all client requirements. This is accomplished through compliance to, and improvements of, the documented Quality Management system and building long-term relationships with our clients and suppliers. 5.5 Responsibility, authority, and communication: Provide the vision and show commitment Embrace those who respect, honor, and value relationships
Management Responsibility Goals and Objectives 12 month rolling average box count = 50,342 54 RVI Warranty returns Average return rate 0.11% 50 45 40 35 30 25 20 15 10 5 0 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 0.40% 0.35% 0.30% 0.25% 0.20% 0.15% 0.10% 0.05% 0.00% Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 PRC Rtns 13 8 8 6 8 3 4 1 0 1 2 0 % Rtn 0.28% 0.18% 0.17% 0.13% 0.17% 0.06% 0.08% 0.02% 0.00% 0.02% 0.05% 0.00% Goal 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35% 0.35%
Quality RVI Corrective Actions Goal < 2 per Quarter from Clients 12 10 8 6 Actual 4 Goal 2 0 QTR 3-10 QTR 4-10 QTR 1-11 QTR 2-11 QTR 3-11 QTR 4-11 QTR 1-12 QTR 2-12 QTR 3-12 QTR 4-12 QTR 1-13 Actual 2 3 10 5 1 7 10 4 1 1 0 1 Goal 2 2 2 2 2 2 2 2 2 2 2 2 QTR 2-13
ISO Broken Down 5 Management Responsibility ( Continued) 5.6 Management Review: Measure your progress Make Improvements
ISO Broken Down 6 Resource Management 6.4 Work environment: 5 Characteristics of a positive Work environment Transparent & Open communication Training Recognition Work-Life balance Team Spirit
ISO Broken Down 7 Product Realization 7.1 Planning of product realization: Determine the process steps ahead of time 7.2 Customer- related processes: Clearly understand the customer requirements for the product or service Make sure you can do it Keep the customers informed and listen to them
ISO Broken Down 7 Product Realization ( Continued) 7.3 Design and development:» RVI is exempt from this requirement Create a design plan Know what you are designing Identify measures for success Review the work as it progresses Verify that you did what you promised Make sure it actually works Scrutinize changes
ISO Broken Down 7 Product Realization ( Continued) 7.4 Purchasing: Know what you want Check out your suppliers 7.5 Production and service provision: Control your processes When you cannot check the product check the process Match the specs to the job Show whether items are acceptable or not Don t break your customers stuff Keep good stuff good
ISO Broken Down 7 Product Realization ( Continued) 7.6 Control of monitoring and measuring equipment: Identify information needed for go / no-go decisions Install equipment capable of providing that information Use the equipment in the proper environment Periodically check the equipment calibration
ISO Broken Down 8 Measurement, analysis, and improvement 8.2 Monitoring and measurement: Keep track of customer satisfaction Examine your internal operations against requirements Report the results to those in charge Check to make sure problems were fixed Watch the processes to ensure they remain capable Check the product against requirements 8.3 Control of nonconforming product: Keep bad stuff away from good stuff Figure out what to do with the bad stuff
ISO Broken Down 8 Measurement, analysis, and improvement (Continued) 8.5 Improvement: Practice never-ending improvement We expect our employees to take a proactive role in our constant improvement. We want our employees at all levels to identify things that can make us continually better at what we do, in a way that supports our values Identify problems and potential problems Determine why the problem occurred Fix the cause of the problem Verify that your changes worked
THINK before you act Quality Techniques Check the supply to the work order for errors or questions before you begin the operations If you have questions Ask your lead!! Understand the Quality requirements for the job Complete the OKS & OKB checklists every time If any changes are needed we need to submit a Process Change Request (PCR)
ISO NOTES TO BE AWARE OF Calibration Any tool used for accept/reject decision making must be calibrated. Rejected Material MRR form must be filled out and followed through we must have evidence of closure Shelflife Always be aware adhesives, loctite. Forklift Do not operate a forklift unless trained and licensed to do so. If you get licensed make sure daily checklist is completed before operation of lift
Key Factors for Success Communication Safety Quality Teamwork Customer Focus
AUDIT PREPARATION
What is an Auditor? An auditor is a person. Their job is to validate documentation. This means they look at documentation (instructions) and make sure people are following the documentation. Auditors are just people who ask questions about how you do your job. NOT an Auditor!
WHAT WILL THE AUDITORS DO? The auditors will look at written procedures and policies (verification). The auditors will then look at and ask how people in the department do things. They will look to make sure each person is following written procedures and policies (this is called validation). They will look at records to ensure everyone is properly completing paperwork (examples would be Global shop checks). They will look to make sure everyone is properly trained to do their job.
THINGS TO DO Listen closely before answering any question(s). Never answer a question you do not understand! Never say Sometimes... Be specific. Always tell the Truth Wait for the auditor to ask a question.
THINGS NOT TO DO If you do not know the answer to a question, tell the auditor that you do not know the answer. Don t attempt to fake it. Do NOT try to answer a question for another person. If the auditor asks you a question about someone else s job, you should answer That is not my job. Do NOT try to hide from the auditor.
General Things To Know and Do Auditors are NOT trying to test your memory. Only answer the auditor s question. Do NOT volunteer information Do NOT try to help the auditor with additional information Do NOT try to explain things beyond the question asked. Do NOT tell stories or speculate what may happen. Answer with the shortest, simplest answer you can think of.
Some Questions to Expect Are you aware of your Quality Policy? - RVIs Quality Policy is covered in orientation training, posters are hung around the bldgs. What documentation/specification(s) do you follow? Show it to me. How do you know you are using the most recent documentation? How do you know what to do? Tell me about your job and your duties. Do you ever have problems come up? How do you handle them? When you find nonconforming product, what do you do?