QSI Document Control. 2 QSI Reference Manual A. The QSI Quality System controls documents using the following databases:

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1 QSI Document Control - Administrator Guide QSI Document Control CHAPTER GOAL The goal is to use the QSI Document Control database to control documents that are required for the quality system in accordance with company policy. OBJECTIVES After studying this manual you should be able to: Navigate to the "Document Control" QSI database on your server. Create new quality system documents. Locate and review documents in the Document Control database. Explain the document creation and approval process. Approve and resubmit quality control documents in the Document Control database. INTRODUCTION Quality System Requirements and our customers require Contech/Metal Forge to implement and use a document control system. The QSI Quality System contains document databases that assist our company in complying with these requirements. The QSI Quality System controls documents using the following databases: Document Control - Create and edit new documents, controls the review and approval process, controls the release process, updates Released Documents, Document Archive, and Employee Training Record databases. Note: Do NOT access the "Document Control" database for current approved documents! Released Documents - Contains the most recent official approved and released quality documents, such as procedures, work instructions, form controls, etc. Document Archive - This is a storage database for all approved revisions of documents and includes procedures, work instructions, form control, specifications, quality plans, and emergency procedures (System 14000). General Archive - The General Archive is a storage database for documents that are no longer needed in the parent database, but that the company must retain for future reference. The General Archive database is used to store the following types of documents Corrective/Preventative Actions, Employee Records, Training Records, Training Schedules, NCMRs, Product and Process Waivers, Inspection Plans and Test Records, certain pages of the Quality Manual, and Calibration/Preventative Maintenance Records are all copied into this database by an archive agent initiated from the main document views for the database and type of document mentioned. 2 QSI Reference Manual A

2 Training Manual DOCUMENT CONTROL The Document Control database is used to create/revise company procedures, work instructions, form control, and other types of documents used in a quality system. It is a working database for documents in the development process. Document Approvers review the document, provide suggestions and guidance, and determine if the document should be resubmitted or approved. All documents go through a review and approval cycle before they can be released as approved documents. Lotus Notes is used to notify approvers when a document is ready for review. The document may be resubmitted to the author with suggested changes or approved. Once all approvers review and approve the document, the release process is initiated. The approved document may be temporarily placed in the Approved- Unreleased Docs database until the specified release date or go directly to the Released Documents database upon approval. Document Release Process Create Document (Write New or Revised Document) Enter Required Data - Title, Dept, Area, Type, Content, Distribution List Identify Allowed Approvers (Refer to SOP-0015/ Portage Server) Submit to approvers for review when content is completed. No Document is Approved Yes Approvers - Approver or Resubmit content to author Submit For Final Approval when all Approvers Approve Review Yes Approvers - Document Approved? No Document Staged for Release Release Agent Auto Runs on Approved Documents Release Selection Determines Path Document copied to Approved - Unreleased Database Release Agent Auto Runs on Approved Documents Updated Employee Training Database with new release information. No Document is copied to Released Documents and Archive Documents Databases. Yes Entered released date arrived? QSI Document Control Administrators 3

3 QSI Document Control - Administrator Guide Document and Data Control CONTECH/Metal Forge complies with customer requirements and international quality standards using the QSI Quality System databases. These requirements and standards specify the company use a document control system. Scope This procedure applies to the quality policies, procedures, work instructions and forms for the Division and all plant sites. Responsibilities Quality Department - Responsible for the administration, issue, and control of quality system documentation in accordance with the relevant work instruction. Document Author/Manager - Responsible for initiating and implementation of newly released and/or proposed changes. Quality Manager - Responsible for establishing a review, including the review of pertinent background data, for documents. Document Control Administrator - Responsible for administering document control and that documents meet Contech/Metal Forge document formatting requirements. Quality Document Definitions and Approval Authority Level 1 - Quality System Policies - These documents originate at the executive management level. They outline and identify the method for complying with specific requirements. Level I documents are located in the Quality Manual database of the QSI application. Level I documents shall be approved by the company President and Director of Quality & Supplier Development. Level II - Quality System Procedures - These documents describe detailed elements of the system by defining the who, what, and when aspects of each quality activity. Level II documents originate at Division and shall be approved by the Director of Quality & Supplier Development plus appropriate Director's with responsibility for the area or activity covered by the procedure. Level III - Work Instructions - These documents describe the activities within a department or business function by describing how activities are carried out. Level III documents shall be approved by the Director/Manager and Management Representative responsible for the area or activity covered by the work instruction. Level IV - Forms and Other Records - These documents demonstrate the performance of and conformance to the Quality System requirements. Level IV forms and records shall be approved by the Director/Manager and Management Representative responsible for the area or activity covered by the work instruction. 4 QSI Reference Manual A

4 Training Manual Section Procedure Steps/Work Instrution Steps/FCD Form The Procedure and Work Instruction Steps section list the steps required to carry out the activity. Procedure and Work Instruction Steps specify the who, what, when, limitiations, equipment and requirments of the activity is performed, and to what standard the activity is performed. The FCD Form section is where the form is attached. Section Safety Information & Environmental - This section lists the safety requirements involved with the procedure, such as personal protection equipment (PPE). This section may include special equipment (specific gage, tool, etc.), clean up steps, waste removal, and/or additional actions to perform the step in a safe and environmentally responsible manner. The minimum statement in this section is None. Section Associate Documents - There are two field sets of field brackets in this section that are used to place document links or attachments. Thie first set of brackets are for document links to related procedure(s), work instruction(s), and/or form control document(s) that are contained within the "Released Documents" database. These documents are selected using the "Documents Associated with this Document" action button (displayed in edit mode). The second set of brackets is a "rich text" field, which may contain any other documents/links that are outside the document control database. For example, links to documents contained in the SPX Contech Document Library (Domino.Doc), website addresses, drawings, reference manuals, and other reference materials (such as preprinted stock room form, etc). Section Document Revision History - This is the document revision record. QSI automatically appends document history in this section. It defines the document revision number, last date of revision, and the last approval date. The document Author is the department manager or assigned person with a Lotus Notes ID. The Document Manager is the plant Document Control Administrator. Section Reason For Change - Documents the reason for the document revision. This section shall contain the revision number, section or paragraph reference number that was changed, and a brief statement of what was changed and the date of the change for each revision of the document. Section Electronic Notification List - This is the list of directors, managers, and/or groups affected by this document. At the Plant Level Department Managers listed in the document header and the plant DCA (QSI_XXXX_DCAdministrator) and HR/Training function (QSI_XXXX _TrainingManagement) must be listed. At the Division Level, Directors and the Document Control Administrator and Human Resource groups must be listed. If the document is posted, identify the controlled location in this section. XXXX = Plant Abbreviation Section Approvers - This lists the names of each approver and the approval status of the document. Minimim requirement are the default approvers and the impacted manager/director. QSI Document Control Administrators 21

5 QSI Document Control - Administrator Guide Paragraph Format Standards Paragraph formatting standards are used to select paragraph spacing and alignment settings. These settings are specific to the type of paragraph heading, main, step, sub-step, sub-sub-step, etc. Use the second tab of the Text Properties dialog box to select paragraph settings. Paragraph Alignment Heading paragraphs are left aligned with the first line outdented to 0.5" Body paragraphs are left aligned and the first line outdented 0.5". Step paragraphs are left aligned and the first line outdented 0.5". Sub-Step paragraphs are left aligned and the first line outdented 0.5". Sub Sub-Step paragraphs are left aligned and the first line outdented 0.6". Paragraph Spacing Heading paragraphs use single Interline, 1 1/2" Above, and single Below settings. Body paragraphs use single Interline, single Above, and 1 1/2" Below settings. Steps use single Interline, single Above, and 1 1/2" Below settings. Sub-Steps use single Interline, single Above, and 1 1/2" Below settings. Sub-Sub-Steps use single Interline, single Above, and 1 1/2" Below settings. 26 QSI Reference Manual A

6 Training Manual Margin Format Standard Margin format standards control left and right margins, tab stops, and pagination settings. Head and Body Text Paragraphs Sub - Step Text Paragraphs Margins Left = 1.0 Absolute Right = 7.5" Absolute Tab stops "Evenly spaced" every 0.5". Margins Left = 1.5 Absolute Right = 7.5 Absolute Tab stops "Evenly spaced" every 0.5". Step Text Paragraph Sub Sub-step Text Paragraphs Margins Left = 1.0 Absolute Right = 7.5" Absolute Tab stops "Evenly spaced" every 0.5". Margins Left = 2.0 Absolute Right = 7.5 Absolute Tab stops "Evenly spaced" every 0.5". QSI Document Control Administrators 27

7 QSI Document Control - Administrator Guide Paragraph Numbering Each paragraph is numbered, including headings. Each paragraph that is a sub-set or sub-step is indented to the right and numbered with a sub-set paragraph number. If correct formatting is applied (as illustrated in the text example below), the readability of the document is improved. You can create paragraph styles that will make formatting each paragraph an easier process. Procedure and Work Instruction steps must be placed in the order or sequence the steps are normally performed for that activity. Review the examples below. Example 1: 5.1 NewTopic - Use Bold Text Attribute Step level paragraph has a 1" Left Margin Absolute and 7.5" Right Margin Absolute with Tab stops every 0.5. Paragraph is aligned left with 0.5" Outdent. Spacing Interline is single, above is single, and below is 1 1/2" Sub-Step level paragraph has a 1.5" Left Margin Absolute and 7.5" Right Margin Absolute with Tab stops every 0.5. Paragraph is aligned left with 0.5" Outdent. Spacing Interline is single, above is single, and below is 1 1/2" Sub Sub-Step level paragraph has a 2.0" Left Margin Absolute and 7.5" Right Margin Absolute with Tab stops every QSI Reference Manual A

8 Training Manual Example 2: 5.9 Red Nonconforming Tag If a customer complaint is received all suspect material must be identified with a Red Nonconforming Tag and placed in containment Only a member of management can remove the tag when the disposition has been decided If the package is Bar Coded, once disposition has been determined and requires rework the Bar Code will be removed. The original Route Tag will be recovered and completed following the Route Tag Work Instruction. Rulers Use the ruler as an aid in aligning paragraphs, especially for re-numbering paragraphs. Click on the ruler icon to display the ruler. QSI Document Control Administrators 29

9 QSI Document Control - Administrator Guide Working Document Markup The Document Author, Document Manager, and other individuals that provide input in the creation or revision of the document can use Lotus Notes to markup and revise the document. When the document is ready for approval, the document author can use "cut and paste" functions in Lotus Notes to update the QSI document. To create a "working document": 1. Open the QSI document. 2. Select Creat -Reply with History from the Menu Bar. 3. Use Lotus Notes text and permanent pen functions to mark up the document. 30 QSI Reference Manual A

10 Training Manual To mark text with the strikethrough text attribute: 1. Select the text using the "click and drag" technique. 2. Select the Text-Strikethrough option from the Menu bar. To insert new or replacement text: 1. Click on the Permanent Pen icon (the status bar on the bottom of the screen indicates when the pen is selected). 2. Click the left mouse button in the document paragraph that you will insert the text. 3. Click on the "Bold" and "Italic" text attribute icons on the toolbar. 4. Type the text in the paragraph. Text color should be "Red" with "Bold" and "Italic" text attributes. The final changes can be copied into the Document Control Draft Document. Non-notes users required a printed copy of the document to markup for revision. QSI Document Control Administrators 31

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