just to give idea of what its content
1.0 Purpose
This procedure describes the process for controlling quality system documents and to assign responsibilities for establishment, review, authorization, issue, distribution, and revision of the quality system documents and data.
2.0 Responsibilities
2.1 Supervisors/Managers are responsible for assigning authors for documents.
2.2 The author is responsible for writing the document, creating related forms, getting a document number and submitting the document to the department manager for review
2.3 Department managers are responsible for approving documents for their area of responsibility.
2.4 The document control coordinator is responsible for assigning document numbers, maintaining the master list, posting new and revised documents on the network, distributing hard copies of documents and revising documents.
2.5 All employees are responsible for reviewing the documents as they use them and submitting document change requests to update documents as necessary.
2.6 The network administrator is responsible for backing up network serves daily.
2.7 Production engineers are responsible for maintaining programs that control equipment.
3.0 Definitions
3.1 Procedure: Document outlining specific work processes and how the requirements of the ISO 9001 standard are being met.
3.2 Work Instructions: Step by step directions on how a task should be done.
3.3 Attachments: Documents used to further clarify or show examples of information described in the procedures and work instructions.
3.4 Forms: Documents used to make a record of completing all or part of the process described in procedures and work instructions.
3.5 Records: Completed forms or information generated as a result of the process described in a document and retained as indicated in the Control of Quality Records Procedure.
3.6 References: External documents or sources used in preparing documentation and completing work.
3.7 Related Documents: Other documents that may need to be altered if the current document is revised or changed.
3.8 Templates: Electronic documents used to create quality system documentation.
3.9 Software Inventory Spreadsheet: List of software being used, indicating current revisions and locations.
4.0 Equipment/Software
4.1 Machine programs, controllers with programs, and other software controlling processes, Production and test software made in-house or purchased is controlled and forms ABC company software library.
4.2 All software should be copied and submitted to Document Control on a compact disc, this should be labeled with: Title, Description, and Revision Label.
4.3 Document Control keeps a software library list of all general non-engineering production software (refer to 4.1) and engineering production software purchased.
4.4 Software that is issued by clients and or ABCs Co.(refer to 4.1). Upon receipt; the software is reviewed for adequacy prior to release for use and is labeled stating this. The following people are approved to review the software: Quality Manager, Engineering Manager and Plant Manager.
5.0 Instructions
5.1 Document Creation
5.1.1 When the need for a document is identified, Management of the department of origin of issue of the document will assign an author for the document. Any employee may be assigned as an author for documents in their area of expertise. Documents and data are identified by their title, Code Number, date of issue, revision level.
5.1.2 The author writes the document and prepares related forms.
Documents include:
a) The Quality System Manual
b) Procedures
c) Work Instructions
d) Attachments
e) Forms
f) References
g) Templates
5.1.3 The author ensures the document is legible and readily identifiable using the appropriate template (Example:T-002)
5.1.4 Documents and data can be in the form of any type media, such as hard copy or electronic media.
5.1.5 Documents and data are identified by their title, code number, revision level,
5.1.6 All documents identify the name of the person who issued the documents
5.2 Approval
5.2.1 The author submits the documents to the department manager and QA- Analyst representative for review and approval; they sign the revision history and approval page as a record of their approval.
5.2.2 The person wishing to initiate a document or a revision submits a draft of the proposed document to his or her supervisor or, in the case of documents issued by QC, directly to Quality Manager. The responsible manager may revise or reject the draft. Regardless of who initiates a document, the responsibility to review, approve, and issue the document always rest with. Documents Control Department.
5.2.3 Prior to issue and release, documents and data are reviewed for adequacy, correctness, and conformity to quality policy. A document is considered to be formally reviewed when an authorized signature is placed on it. The following persons are authorized to approve documents and data: Engineering Manager, Plant Manager, and Quality Manager.
5.2.4 Inspection and work instruction are issued by the clients, U.S. agencies, and/or ABC, Inc. departments that use them. However, in matters that concern product specification and product verification, only Engineering and Quality may approve inspection and work instructions, regardless of where they are used.
5.2.5 The Document Control Coordinator inserts the approver’s initials into the electronic copies when posting approved documents.
5.2.6 Document changes are approved by an individual in the same function that performed the original review and signed the original document indicating approval.
5.3 Document Identification and Distribution
5.3.1 All documents contain the following information:
a) Company name
b) Title
c) Document Number
d) Current Revision and Date
e) A unique document number
5.3.2 The quality manual and operational procedures both have a distribution list printed on the page after the title page.
5.3.3 Revisions of documents are distributed to the same personnel and locations as the original issues. Every copy of a revised document is distributed and contains a brief description of what has been changed and any special instruction if required.
5.3.4 After formal review of documents as per 5.2, the documents are submitted to Document Control. The Document Control Dept. checks the documents and puts them in the Master List. If document already exists, the revision level will be updated.
5.3.5 Documents for release are stamped with “CONTROLED” red Stamp for distribution and use of document. All document it does not have this stamp is considered a uncontrolled Document. Production Documents issued internal or external (Drawing, Planning and ECO) should be distributed to the Production Manager, Quality Control, and Material Specialist. These persons are responsible for archiving and updating their file system to the documents released to them. Work instructions are released to the production line to be used. Component’s Drawing and Component’s Document Specification are released to Purchasing and the receiving inspection Department.
5.3.6 The persons who received a released document must place their signature and or initials in the control log form.
5.3.7 When a is received, the Document Control Coordinator have to update the Master list and distributed to the person that has possession of the document changed, following same distribution procedure of the document changed.
5.3.8 It is not allowed to distribute, use or copy documents not released by the Document Control Department.
5.3.9 For the purpose of traceability the Quality System Manual controlled copies are numbered.
5.3.10 All documents are to be released as soon as possible.
5.4 Document numbering
5.4.1 Operational procedures are code numbered QSOP-RR. QSOP stands for Quality System Operational Procedure; RR is the number of quality system manual section to which the procedure pertains. For example the Document Control procedure related to section 423, therefore the procedure is numbered QSOP-423.
5.4.2 Work instructions, forms, and attachments are numbered using the following number scheme:
5.4.3 The purpose of production plans is to sequence and coordinate production operations. Quality plans define the inspection/testing points and methods, and reference specific inspection instructions and acceptance criteria.
5.4.4 Production and quality plans are primarily documented and coordinated on the Traveling Work Order. The Work Order lists all production steps and inspection Points, and references the drawings.
5.4.5 Production plans are coded as MPP-XXX-NNN, where MPP means Manufacturing Process Procedure, XXX product group code and NNN is a sequence number.
5.4.6 The product group codes are for example MAG for magnetic, ASSY for assembly, CIR for circuit.
5.4.7 Quality plans are coded as QCPNN, where NN is a sequence number.
5.4.8 The Production department/line issues travelers. The Production and Quality Managers authorize them prior to use.
5.4.9 The following departments prepare issue and maintain QMS documentation as required:
(E) Engineering: Design Engineering and all related functions
(M) Manufacturing: Production, Service, Warehousing, and Inventory control.
(S) Sales: Marketing, Sales, and Customer Service
(A) Administration: Management, Human Resources, Accounting, and Purchasing
(Q) Quality Assurance: Quality Assurance and Quality Control, Inspection and Document and Data Control
5.4.10 Work Instructions are numbered WI-XXX-NNN, where XXX is the related procedure number or the product group code, and NNN is a number assigned sequentially as work instructions for that procedure are entered.
5.4.11 Forms and attachments are numbered using the word “Form” as prefix; follow by XXXX sequence of number. For example: FormXXXX.
5.4.12 Quality system Forms are numbered as F-XXX-NNN by using the F for forms and “XXX” for the number of the Quality Operational Procedure related and “NNN” is a sequence number.
5.4.13 Authors obtain the document number from the Document Control Coordinator.
5.4.14 Approved documents are submitted to the Document Control Coordinator and entered on the Master Document List as outlined in the Master Document List work instruction. Approved documents containing original signatures are the “Master” copies and are kept in the Master Document file.
5.4.15 The Document Control Coordinator releases and distributes hard and/or soft copies of the new and revised documents to points of use according to the Master List.
5.4.16 Hard copies are controlled by listing the distribution of the document on the master list and stamp “CONTROLED” to indicate they are controlled.
5.4.17 The document templates include an auto print date. Electronic copies of procedures work instructions and attachments that are printed for use are controlled by this print date. Printed copies are only valid for 24 hours from the print date unless stamped “controlled copy” in red ink. Copies of these controlled documents are not authorized.
5.4.18 References are numbered REF-XXX-NNN, REF stand for Reference, “XXX” for the product group code and “NNN” is a sequence of number. Once a reference is assigned a number it can be used as a reference for numerous documents under the original number it was assigned.
5.5 Document revisions
5.5.1 Documents are reviewed during regular use and during internal audits. Documents are updated as found necessary during these reviews.
5.5.2 Documents are revised to update or clarify information using the Document Change Notice Form.
5.5.3 Revisions are made electronically and the revision is recorded in the revision section of the document.
The Document Control Coordinator uses the document revision checklist (Form 423-002) to ensure that all steps are completed.
5.5.4 Revisions to documents go through the preceding document approval, identification, and distribution steps. Document changes are approved by an individual in the same function that performed the original review and signed the original document indicating approval.
5.6 Obsolete Document Disposition
5.6.1 One hard copy of the obsolete document is retained and marked “OBSOLET”. The document change Notice is retained with the archived copy.
5.6.2 Electronic versions of obsolete documents are marked “OBSOLET” and moved to an archive electronic folder named obsolete for reference use.
5.6.3 Obsolete documents that are retained for preservation of knowledge or legal reasons are stamped “OBSOLETE. Cabinets containing archived documents are segregated from those containing active documents.
5.7 Electronic Backup
5.7.1 Company ISO documentation is stored on the company network. An electronic backup is made weekly by the network administrator.
5.8 Control of Data
5.8.1 All programs used for control of production equipment, calculations or analysis are controlled. They are listed on the software spreadsheet with revision date and location of the program.
5.8.2 Production engineers maintain programs controlling equipment in a protected file. Operators use read only copies of the programs.