Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Westinghouse’s RPE ©Journey with DOORS Nuclear Automation Thomas W. August Westinghouse Electric Company LLC DOORS Administrator and Trainer 412.374.3855 Rev 1.0a 1 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Safety and Administrative • Location of exits • Fire drills scheduled • Please be mindful of any items on floor • Location of restrooms • Cell phones and/or pagers set to vibrate • Proprietary Information for Level 3 Procedures 2 2 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Agenda 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Brief Overview of DOORS Six-Sigma Analysis Lessons Learned with RPE POC Generic Templates Export ME (from River North Solutions) Export ME Improvements Simple Example for Standardization Sidebar and Blackline Text Weaving Documents Saving Document Creation Information in the Document Smarter Templates Summary and Discussion Questions and Demo 3 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Traceability view User Reqts 1. 820.30(b) Design and Development Planning Technical Reqts Design 1. 820.30(b) Design and Development Planning The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. Comply with FDA Design Control Guidance GMP Regulation Each manufacturer shall establish and maintain plans that describe or reference the design and development 1.1. Identify impacted elements due to a change in another element activities and define responsibility for implementation. 1. Capturewith design and related information driving design elements Traceability Reports: consistency Input electronically Impact Reports: other design1.1. elements affected formatted data The plans shall identify and describe the interfaces with different groups or activities that provide, or result 1.2. Reference external information sources in, input to the design and development process. Links to impacted design elements 1.3. Reference external documentation The plans shall be reviewed as design and development evolves. The plans shall be updated as design and development evolves. The plans shall be approved as design and development evolves. The plans shall be reviewed as design and development evolves. The plans shall be updated as design and development evolves. The plans shall be approved as design and development evolves. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. 2. 820.30(c) Design Input 2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. 2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. 2.3. The procedures shall include a mechanism for addressing incomplete requirements. 2.4. The procedures shall include a mechanism for addressing ambiguous requirements. 2.5. The procedures shall include a mechanism for addressing conflicting requirements. 2.6. The design input requirements shall be documented by a designated individual(s). 2.7. The design input requirements shall be reviewed by a designated individual(s). 2.8. The design input requirements shall be approved by a designated individual(s). 2.9. The approval, including the date and signature of the individual(s) approving the requirements, shall be documented. 2.10. Questions. 2.10.1. Summarize the manufacturer's written procedure(s) for identification and control of design input. 2.10.2. From what sources are design inputs sought? 2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and list additional aspects.) 2.10.3.1. intended use 2.10.3.2. user/patient/clinical 2.10.3.3. performance characteristics 2.10.3.4. safety 2.10.3.5. limits and tolerances 2.10.3.6. risk analysis 2.10.3.7. toxicity and biocompatibility 2.10.3.8. electromagnetic compatibility (EMC) 2.10.3.9. compatibility with accessories/auxiliary devices 2.10.3.10. compatibility with the environment of intended use 2.10.3.11. human factors 2.10.3.12. physical/chemical characteristics 2.10.3.13. labeling/packaging 2.10.3.14. reliability 2.10.3.15. statutory and regulatory requirements 2.10.3.16. voluntary standards 2.10.3.17. manufacturing processes 2.10.3.18. sterility 2.10.3.19. MDRs/complaints/failures and other historical data 2.10.3.20. design history files (DHFs) 2.10.4. For the specific design covered, how were the design input requirements identified? 2.10.5. For the specific design covered, how were the design input requirements reviewed for adequacy? Test Cases 1.1.1. Create backward traces to design elements within and across any organizational 2. Store design and related information procedure 2.1. Identify and tag design information as unique “design elements” Attribute Traceability Reports: Procedure 2.2. Organize design elements 1.1.2. Create backward traces to design elements andControl acrossGuidance any project milestone 2.2.1. Organizewithin by Design Element 2. 820.30(c) Design Input Attribute Traceability Reports: Milestone 2.2.2. Organize by inter-relationships 2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating a 2.3. Ensure all design elements available 1.1.3. Createto backward traces to design elements within and are across Design Control device are appropriate and address the intended use of the device, including the needs of the user 2.3.1. Store design elements by Design Control Guidance Element Guidance Elements and patient. 2.3.2. Store design elements and their historical values Reports: Linked design elements Traceability 2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to a Create forward impacts3.to design within and across any organizational device are appropriate and address the intended use of the device, including the 1.1.4. needs of the user Manage elements all user needs and patient. procedure 3.1. Identify the source of the user need 2.3. The procedures shall include a mechanism for addressing incomplete requirements. 3.2. Identify all user types (groups) Impact Reports: Procedure Attribute 2.4. The procedures shall include a mechanism for addressing ambiguous requirements. 3.3. Identify the customer 1.1.5. Create forward impacts to design elements within(s) and across any project milestone 2.5. The procedures shall include a mechanism for addressing conflicting requirements. 3.4. Profile the expected patients Attribute Impact Reports: Milestone 2.6. The design input requirements shall be documented by a designated individual(s). 3.5. State the intended use of the product (family) 2.7. The design input requirements shall be reviewed by a designated individual(s). 1.1.6. Create forward impacts to design elements within and across Design Control 3.6. Capture the acceptance criteria for each user need 2.8. The design input requirements shall be approved by a designated individual(s). Guidance Elements 2.9. The approval, including the date and signature of the individual(s) approving the requirements, 4. Manage input requirements designdesign elements Impact Reports: Linked shall be documented. 4.1. Identify the source of the requirement 1.2. Associate changed design elements with related elements 2.10. Questions. 4.2. Identify the associated user need 2.10.1. Summarize the manufacturer's written procedure(s) for identification and LinkofChange Design Object 4.3. withCapture affected design element(s) control requirement description and attributes design input. 4.4. from Capture acceptance criteria affected design element(s) Traceability Links and Reports 2.10.2. From what sources are design inputs sought? 4.5. affected Assign responsibility for each requirement Links and Reports from design element(s) thatImpact 2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all apply and 4.6. Manage incomplete requirements 1.2.1. Associate design element changes with decisions, rationale, and approval authority list additional aspects.) 4.7. Manage ambiguous requirements 2.10.3.1. intended use information 4.8. Manage conflicting requirements 2.10.3.2. user/patient/clinical following Attributes: Approve all requirements Change Decision Objects4.9.with 2.10.3.3. performance characteristics Disposition Attribute 2.10.3.4. safety 5. Manage acceptance Decision Attribute 2.10.3.5. limits and tolerances 5.1. Ensure the acceptance of every user need 2.10.3.6. risk analysis Rationale Attribute 5.2. Ensure the acceptance of every design input requirement 2.10.3.7. toxicity and biocompatibility 5.3. Document the results of every user need acceptance test Owner Attribute 2.10.3.8. electromagnetic compatibility (EMC) 5.4. Document the results of every design input requirements test Management Approval Attribute 2.10.3.9. compatibility with accessories/auxiliary devices 5.5. Make acceptance results available 1.2.2. Provide associations within and across any organizational procedure 2.10.3.10. compatibility with the environment of intended use 2.10.3.11. human factors Link on Procedure Attribute Change Design Object 6. Traceability Manage change 2.10.3.12. physical/chemical characteristics 6.1. Maintain of design Attribute element changes Change Design Object Impacts Link history on Procedure 2.10.3.13. labeling/packaging Makeany complete change history available 1.2.3. Provide associations within and6.1.1. across project milestone 2.10.3.14. reliability 6.1.2. Maintain history within and across any organizational procedure Change Design Object Traceability Link on Milestone Attribute 2.10.3.15. statutory and regulatory requirements 6.1.3. Maintain history within and across any project milestone 2.10.3.16. voluntary standards on Milestone Attribute Change Design Object Impacts 6.1.4.Link Maintain history within and across any Design Control Guidance Elements 2.10.3.17. manufacturing processes natureGuidance of element changes 1.2.4. Provide associations within6.2. andCapture acrossfrequency Design and Control Elements 2.10.3.18. sterility 6.2.1. Provide fordesign change elements Linkrationale to traced Change Design Object Traceability 2.10.3.19. MDRs/complaints/failures and other historical data 6.2.2. Describe decisions made Link to linked design elements 2.10.3.20. design history files (DHFs) Change Design Object Impacts 6.2.3. Identify approval authority for the change 2.10.4. For the specific design covered, how were the design input requirements identified? 1.3. Mange the change process 6.2.4. Capture date, time, and signature of approving authority 2.10.5. For the specific design covered, how were the design input requirements reviewed forChange Module 6.3. Identify impacted elements due to a change in another element Design adequacy? 6.3.1. Create backward traces to design elements within and across any organizational procedure Design Change Reports 6.3.2. Create backward traces to design elements within and across any project milestone Object History Object History Reports Versions Baselines 1.1. Identify impacted elements due to a change in another element Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements 1.1.1. Create backward traces to design elements within and across any organizational procedure Traceability Reports: Procedure Attribute 1.1.2. Create backward traces to design elements within and across any project milestone Traceability Reports: Milestone Attribute 1.1.3. Create backward traces to design elements within and across Design Control Guidance Elements Traceability Reports: Linked design elements 1.1.4. Create forward impacts to design elements within and across any organizational procedure Impact Reports: Procedure Attribute 1.1.5. Create forward impacts to design elements within and across any project milestone Impact Reports: Milestone Attribute 1.1.6. Create forward impacts to design elements within and across Design Control Guidance Elements Impact Reports: Linked design elements 1.2. Associate changed design elements with related elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s) 1.2.1. Associate design element changes with decisions, rationale, and approval authority information Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute 1.2.2. Provide associations within and across any organizational procedure Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute 1.2.3. Provide associations within and across any project milestone Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute 1.2.4. Provide associations within and across Design Control Guidance Elements Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements 1.3. Mange the change process Design Change Module Design Change Reports Object History Object History Reports Versions Baselines End-to-end visual validation in a single view 4 4 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Definitions • DOORS = Dynamic Object Oriented Requirements System – This is a requirements management tool used to manage all of the sets of requirements across multiple programs for many different customers • RPE = Rational Publishing Engine – This is a publishing tool used with DOORS and other tools to build customer deliverable requirements and design documents from the DOORS modules – Two main components – as “Document Studio” for creating templates and a “Launcher “ for executing specifications 5 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. RPE Specification Content – (DSX) DSX file Specification Output can be MS Word PDF HTML XSL-FO A Style sheet in RPE speak is actual a MS Word template (dot) Output information Output format Output Name location DTA file Style Sheet (MS Word dot file) Output normal to your D drive /data/documents to allow macro to run. Templates (input data location) database queries, layout, formatting master pages (which define header, footer, orientation, and paper size) Attributes Variables 6 6 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Original “Publishing” Process with DOORS 7 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Six Sigma Analysis (Customer 1st in Westinghouse Speak) • SIMPLIFIED PROBLEM STATEMENT: – Generation of Requirement Documents from DOORS with the level of formatting required by Westinghouse is prone to multiple iterations of manually updating DOORS and re-issuing. – This results in a high likelihood of human error due to double work (updating in word & transferring updates to DOORS), higher costs due to multiple cycles through review and approval groups, lengthy approval cycle times, and low satisfaction by the authors/leads responsible for the various requirements specifications on the projects. – Analysis started 2008 8 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Six Sigma Analysis (Customer 1st in Westinghouse Speak) • OBJECTIVE: 1. Reduce the number of cycles from DOORS to the final Quality Record 2. Simplify the Document Generation Process 3. Reduce or eliminate opportunities for errors 9 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Six Sigma Analysis (analysis summary) • We identified 23 opportunities for human error in our • • • • • • process that could cause the DOORS data to be out of synch with the Quality Record Too many hand-offs between groups outside of DOORS Very little automation Manual efforts were required to reduce potential risk Original process contained excessive rework DOORS loss of credibility in People/Process Negative Effects of Rework – missed due dates, milestones, and schedule impact. 10 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Six Sigma Analysis (proposed new workflow) Created optimal workflow using RPE: (after determining the real requirements) 1. 2. 3. 4. 5. 6. 7. The least amount of rework The highest amount of collaborative engineering The smallest amount of concern for format/output for engineers Higher use of standardization with DOORS Place all Front Matter in DOORS module Trained all groups to work in DOORS to eliminate out of sync opportunities Much faster and repeatable output (result in DOORS to Quality Record cycle time reduced by 70%) 11 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. 12 12 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Six Sigma Analysis (Pilot proposed solution) Tested Proof of Concept with RPE 1.1.1: 1. 2. 3. 4. 5. Error opportunities were reduced Reduced out of sync opportunities Process was much faster It did enhance standardization Some user complaints were still not satisfied: – – Still needed a markup copy of exported document for reviewers to see what changed Change bar indicator produced by the tool did not meet users needs 13 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Lessons Learned with RPE and improvement we made Users do not want to learn how to create templates and specification. They just want to click and get a document: 1. We standardized the views for use with templates 2. Minimized deployment of RPE Studio (helped reduce use of RPE licenses and encourage standardization) 3. Introduced the use of Export ME publishing script (by River North Solutions) 14 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. RPE 1.1.2 Generic Templates (ABC,D, & E) • Templates A, B, and C have been combined into one template and will use RPE-PartA, RPE-PartB, and RPE-Part C views as default. • Templates have logic to detect Project and/or Subsystem differences. • Template E can be used to create tables and RTMs directly from view (regardless of the attributes used) RPE Template DOORS View Part of Document Generic_112 PartABC RPE-PartA Title Page (Combines views A, B, and C) RPE-PartB List of contributors thru Open Items RPE-PartC Acronyms up start of Main Content Generic_112 Part D RPE-PartD Main Content Generic_112 PartE RPE-PartE Tables created from Views not tables 15 15 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. One-Button Document Publishing • We use “Export MeTM” to produce an MS word document from DOORS using predefined, standard views – as seen here in RPE-Part[A,B,C,D] views in each module 16 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Export Me Script helped (but we still had a lot of specifications) Every document still required its own specification. – – – – One of our users has over 200 modules and each document required a specification. If we could create a specification in 30 minutes that would be 100 hours of work If we had to update a template, we would have to update 200 specification. The one specification per document is due to the need to provide the module ID in each Specification. 17 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Export Me improvement (proposed modifying Export Me to provide the Module ID) I theorized that if we could modify Export Me to provide the Module ID when it called the Specification, we could reduce 200 specifications to one. – – – – I discussed the idea that I called “Self ID” with Felix Morariu of IBM and Bob Parro III of River North Solutions (RNS). Felix agreed that the idea was feasible and he suggested using XML to create the method for “Self ID”. After discussing the idea with Bob, he started experimenting with the idea and was able to modify Export Me to actually do it. Now we can use one specification for hundreds of documents and updating the template is significantly reduced. 18 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. More Export Me improvement needed (we need to print multiple document from one module) As we used our product on more plants, we needed to make some changes to our document for each Customer site. – – – – – Using views and filters we could produce multiple documents from one module, but Export Me could only produce one per module. We worked with Bob Parro III of RNS to develop a menu process of Export Me to accommodate multiple documents Now we can produce any combination of one or more documents from one module. If we need to produce a set of documents for 4 different sites with the same 200 modules, we only need 4 specification instead of 800. Can you calculate the savings in setup and maintenance? 19 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Export Me™ allows production of RPE exports with minimal clicks RPE Document Specification (.DSX) File: - Defines data source - Defines values for variables - Defines output formats and associated parameters - Defines templates to be used - Stored in centrally accessible location - We use logic to detect project specific formatting needs - Word styles are assigned to attributes 20 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. New Version of Export Me can create a Menu for Multiple Documents from one module • We can now print multiple Documents from one module • No limit to number of documents per module • You can select one, all, or any combination 21 21 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Simple example for Need to standardize (attribute order after requirement) • Different Attribute order after the Requirement – – – – – – Guidance Exception Rationale Source Requirement Classification Plant Applicability NOTES: Some users place Rationale before Guidance. This could cause us to create and maintain duplicate templates. 22 22 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Change Indicator and Blackline text (solving the last two complaints about using DOORS) We worked with RNS to create a method on creating a sidebar indicator with DOORS. – – We created the sidebar attribute to “Show” or “Hide” an equivalent image for the MS Word change bar. Its granularity is to the attribute level not a single line. We worked with RNS again to create what we call “Blackline Text” for any attribute string or attribute text within a module to show changes in text. 23 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Example of Blackline Text 24 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Menu Blackline Text is an improvement over the old Dynamic History DXL (Now we can do any String or Text attribute) 25 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Weaving Documents • One of our groups needed to produce over forty documents from DOORS, but some key sections are the same in all the documents. • We created a module with all the standard sections in it and used standardized views. • We weave these sections into any one of the forty module when the document is printed. • When the standard sections need revised, we can make the change in one place and the document can get the update the next time it is printed. 26 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Weaving Documents (The Standard Module ID is the Specification and Export Me supplies the module ID for the Document) 27 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Save Document Creation Information (for trouble shooting and/or recreation needs) The list below represents the configuration management information that is stored in the document properties, e.g., the meta data of the exported document. – Source DOORS Version – Document Specification – Source Module and View Names: Module+View name pairs are documented for as many modules and views are published – Publish timestamp – RPE Version During Publish – OS Username During Publish – OS Name During Publish – OS Architecture During Publish – OS Version During Publish – Host Name During Publish 28 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Creating Smarter Templates RNS suggested ways we can reduce our number of templates and specifications even more. 1. Add logic to the template to detect project name and adjust the template for project difference. 2. Instead of using the DOORS attribute “Paragraph Style”, assign style based on usage and attributes 29 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Transform ME 1. We created a tool called Transform Me to move some of our structure information into attributes. 2. This allows us to assign style to attributes and relieve the engineer from some formatting activities (engineer can focus on ontent not formatting). 30 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Summary • With the combination of the following methods we are learning to produce documents for DOORS faster and with less maintenance. – – – – – – – – TransformME Export ME with XML switch and menu Weaving Sidebar attributes Blackline Text Standardized default views Using Template logic Assign styles based on attribute and usage 31 Westinghouse Non-Proprietary Class 3 © 2012 Westinghouse Electric Company LLC. All Rights Reserved. Demo and Questions 32 32 32