GSFC Quality Management System ISO 9001 and You

GSFC Quality Management System ISO 9001 and You http: //arioch. gsfc. nasa. gov/iso 9000/index. htm

ISO 9001 - A Quality Management System Can we talk? What’s this about ISO 9001? What’s a Quality Management System? Relationships: ISO 9001 & QMS Scope -- How big is thing? What Are Our Expectations Foreseen Obstacles GSFC’s Quality Policy Systematic Approach More Questions 2

ISO 9001 - A Quality Management System ISO 9001 -- there in the title -- what is that? – ISO 9001 is an international standard: Quality Systems— Model for Quality Assurance in Design, Development, Production, Installation, and Servicing. – – – It’s part of ISO 9000, which defines a basic management system for any organization. ISO 9001’s title includes the word “quality”, but it’s a business system with a focus on product quality through process control. The US has adopted it as ANSI/ASQC 9001. 3

ISO 9001 - A Quality Management System Why are we talking about this? Don’t do a Top Ten List…please. – ISO 9001 is important to us because it is: International, which is our forum. NASA policy, as outlined in NPG 1270. 3. Identified as a GSFC high priority objective. A good foundation on which to build an effective and efficient organization. – It will affect most of us in some way through its affect on the Center’s operating processes. 4

ISO 9001 - A Quality Management System So how is ISO 9001 supposed to work? – Its requirements are WHAT we need for an effective quality system. – It doesn’t tell us HOW to work--that’s our job. – We need to document how we do things, do them that way, and keep objective evidence. – It doesn’t replace product specifications or regulations, such as safety and environmental. – We will be certified by a Registrar that we meet the requirements and then have 6 month checkups--a journey and not a destination. 5

ISO 9001 - A Quality Management System Tell me why this might be a good idea? – From a customer perspective (them, not us), ISO 9001 registration demonstrates we have a system for delivering quality products. – From a supplier perspective (us, not them), ISO 9001 registration means we have processes in place to: Understand meet customer expectations. Ensure that quality is a management practice. Measure how well we do and to improve. 6

ISO 9001 - A Quality Management System Okay. Now, Quality Management System? – The Quality Management System (QMS) is the set of GSFC policies and procedures that addresses ISO 9001 requirements. – The QMS is a hierarchy, or pyramid, of documents and quality records. – The structure allows a potential customer or registrar to trace how ISO 9001 requirements flow down through the Center. 7

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ISO 9001 - A Quality Management System So tell me about these levels. . . – Tier 1 is our Quality Manual; it describes our commitment to quality, our organization, and our implementation of ISO 9001 --it’s most useful to outsiders, allowing them to connect ISO 9001 to our QMS. – Tier 2 is the set of Goddard Procedures and Guidelines (GPGs) that address the ISO 9001 requirements--these are procedures from a Center perspective that speak directly to the 20 elements of ISO 9001 Section 4. 9

ISO 9001 - A Quality Management System Go on--I can tell you’re going to. . . – Tier 3 are the Directorate and lower procedures used to implement the GPGs--if the details of implementation are left to the Directorates or lower level organizations, here they are. – Tier 4 are the Work Instructions used by employees in doing their work. Work instructions might be procedures, handbooks, flow charts, drawings, checklists, forms, or anything that provides us with directions for specific duties. 10

ISO 9001 - A Quality Management System Finally, the bottom of a $25, 000 Pyramid… – The foundation of the QMS is our Quality Records--ISO 9001 requires objective evidence of QMS implementation and these records are it. – The need for specific records is in the procedures. 11

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ISO 9001 - A Quality Management System Okay, I’ve got that -- now what are the 20 elements we need to talk about? – ISO 9001 Section 4 has 20 subsections: 4. 1 Management Responsibility 4. 2 Quality System 4. 3 Contract Review 4. 4 Design Control 4. 5 Document and Data Control 4. 6 Purchasing 4. 7 Control of Customer-supplied Product 4. 8 Identification and Traceability 13

ISO 9001 - A Quality Management System And that was only 8… 4. 9 Process Control 4. 10 Inspection and Testing 4. 11 Control of Inspection, Measuring, and Test Equipment 4. 12 Inspection and Test Status 4. 13 Control of Nonconforming Material 4. 14 Corrective and Preventive Action 4. 15 Handling, Storage, Packaging, Preservation, and Delivery 14

ISO 9001 - A Quality Management System You did say there were 20, didn’t you. 4. 16 Control of Quality Records 4. 17 Internal Quality Audits 4. 18 Training 4. 19 Servicing 4. 20 Statistical Techniques 15

ISO 9001 - A Quality Management System An example of some sort might help with the connection. . . – For instance: ISO 9001 Section 4. 11 Control of Inspection, Test, and Measuring Equipment GPG 1270. 3 GSFC Quality Manual GPG 8730. 1 Calibration and Metrology 303 PG 8730. 1 Calibration and Metrology Lab 303 WI 8730. 5 Automatic Recall System Quality Records -- Auto-Recall Equipment List, Equipment Calibration and Maintenance Database 16

ISO 9001 - A Quality Management System All well and good, but what will this look like in the end? – We are not reinventing the Center with the QMS: We are documenting existing procedures, some with a twist, such as going on-line, re-engineering, or streamlining. We are establishing formal procedures where things were done ad hoc. We are creating new systems only to meet requirements otherwise not addressed. 17

ISO 9001 - A Quality Management System You said ISO 9001 applies to products -- so what are we talking about here at GSGC? – The QMS covers nearly everything we do for external customers, including what we do for each other that ends up in the external customer’s product. – More specifically, Center management included anything produced by the five major processes with which we operate. – Products resulting from these processes are within Goddard’s Scope of Certification. 18

ISO 9001 - A Quality Management System Science Enabling This includes: the grants process; providing data to the science community (e. g. , ESDIS); science support tools (e. g. , IMDC); proposal support process; science research management process (e. g. , visiting committees and peer reviews). Systems Development This includes: space; balloons; sounding rockets; aircraft experiments; ground systems; data systems. 19

ISO 9001 - A Quality Management System Program/Project Management This includes: cost, schedule, and technical control; review and reporting; budgets; contracts; procurements; safety and mission assurance. Technology Enabling This includes: new concept studies; investment strategies; crosscutting developments; mission specific products; transfer; commercialization. Mission Operations This includes: customers service commitments, including PSLAs and PCDs. 20

ISO 9001 - A Quality Management System So how do I know if my work is covered? – The QMS involves you when you are working on something that either will be delivered to a customer or contributes to something that will be. – Some organizations may have only part of their responsibilities included in the QMS. – Some people may have only part of their work included in the QMS. 21

ISO 9001 - A Quality Management System And what about our contractors? – Agency policy on purchasing requires our suppliers to be compliant with ISO 9001, not certified or registered to it. – Support contractors fit into one of three areas: If off-site, they are suppliers and will be required to be compliant. If on-site and they use their own procedures, they are suppliers and required to be compliant. If on-site and they use our procedures, they are subject to our Registrar’s audits. 22

ISO 9001 - A Quality Management System You said the QMS would affect nearly everyone -what things do we watch for? – The QMS procedures most likely to directly affect you are: Documentation Corrective/Preventive Action Quality Records Internal Audits 23

ISO 9001 - A Quality Management System So if this Great Pyramid of documents falls on me. . . – Document Control is big--we need to keep documents up to date, use the correct revisions, and get rid of obsolete copies. – In some cases we will need more documents, although no more than our procedures require--we should be lean and focused. – Many of us already have what we need--it’s a matter of controlling and then using what we have. 24

ISO 9001 - A Quality Management System And how are we going to help this along? – To comply with ISO 9001 as easily as possible: All the QMS documents will be on the Internet. To assure control, the official copy will be the on the screen--printed copies are okay to work with but they are uncontrolled. Some Work Instructions will likely be outside the Internet system because of their form--these may have to be controlled the old fashioned way, as paper, or in other computerized systems. 25

ISO 9001 - A Quality Management System Talk some about Corrective/Preventive Action -- a form of after school detention? – The Corrective Action System assures that quality problems are taken care of by someone. – The Preventive Action System seeks the root cause of failures. It tries to fix the process rather than focus on a failure--it asks why. – Neither can be effective if perceived as punitive. The focus is on ensuring that procedures and processes are right and are reliable, resulting in quality products. 26

ISO 9001 - A Quality Management System And Records -- now we have to keep records of everything? – – – There will be records, but remember that the QMS will tell us what records we need to meet the requirement for objective evidence. For many of us, it won’t be new records but better control of existing records--we need a good records management system. This also doesn’t replace statutory or regulatory record keeping requirements, which are likely to be different (and maybe more extensive). http: //arioch. gsfc. nasa. gov/iso 9000/index. htm 27

ISO 9001 - A Quality Management System Internal Audit -- another intrusion? – ISO 9001 requires an effective and continuous system of internal audits. – It is a self-check on how well we implement the QMS and how well it is working. – Nonconformances and Observations from audits will be used to fix or improve procedures. – The collection and analysis of audit results helps improve effectiveness and efficiency--combined with preventive actions, this is the potential gain from ISO 9001. 28

ISO 9001 - A Quality Management System If we aren’t the first to do this, have you learned what we should watch out for? – It won’t take rocket science to fix about 85% of “normal” problems identified by a registrar. People not following the established procedure-- not complying, not qualified, no access (50%) A procedure doesn’t exist or isn’t under control--not documented, unofficial, out of date (20%) A procedure isn’t adequate for the work--work practices are different from procedure (15%) 29

ISO 9001 - A Quality Management System Okay, but wanting to deliver quality products doesn’t seem like real news. – The QMS includes a Quality Policy that Center management formulated to meet an ISO 9001 requirement. – It doesn’t say anything new to us--the ideas are all part of our culture and heritage and are in our various strategic documents. 30

ISO 9001 - A Quality Management System Goddard Space Flight Center Quality Policy – – GSFC is committed to meeting or exceeding our customer’s requirements We strive for excellence in all of our efforts Professionalism, integrity and efficiency are our trademarks Customer satisfaction is our foremost objective 31

ISO 9001 - A Quality Management System Explain to me how this is being done … – The effort is organized as a project: Center management established a Project Office, a center-wide QMS Council, and approved a plan for an April 1999 registration date. The Project Office is working QMS development with the QMS Council, management, and other Center personnel on an as-required basis. Everything QMS can be found on the ISO 9001 website (linked to the Center’s homepage); plans, who’s who, meeting notes, status reports, draft documents, external links, and more. 32

ISO 9001 - A Quality Management System Now that you’re almost finished, how about telling us where we are in this? – The status of the ISO 9001 Registration effort: We are finishing our Tier 2 procedures that define, create, or document Center processes. We are starting to document Tier 3 processes. We are planning the activation of the internal audit and corrective/preventive action systems. More training is being planned, particularly for both auditors and employees. 33

ISO 9001 - A Quality Management System So what if a question comes to me at a slow point in a Late Show rerun? – – For organization-specific questions, start with your supervisor as a first point of contact. For general questions, start with the FAQs and other information on the website. If you don’t see what you need, use the button on the website to submit questions (or comments or suggestions); we reply to everything. As a parallel path, review old Dilbert strips for insight. 34

ISO 9001 - A Quality Management System ISO 9001 Quality Management System Relationship Of The QMS To ISO 9001 Scope Of Certification Most Likely Affects Common Failures GSFC’s Quality Policy Center’s Approach To Registration Finding Answers 35

ISO 9001 - A Quality Management System These things seem to always end with a patriotic plea -- couldn’t you just skip that? Registration is for the entire Center and not just parts of it. 36