ISO 9000:2000 Document Control Procedure P423

G

gheghe

#1
ISO sample documents

I'm gettin more and more confused about ISO documentation everyday. Included in the ISO2k package is the document control procedure P423. What level is this? What our ISO company rep. said "you don't need to reinvent the will" you just cut and replace and there you have a document control procedure"and thats what he did, when I reviewed it, it looks general to me,(that's why im asking what level is that), and I told him that we need to have a third level document for the step by step control procedure. And he said no need for that. I said, In that case we need to indicate in P423 the step by step procedure. and he said no, don't reinvent the will. Does ISO truly require to use that formatting and that procedure sequence indicated in P423? today, we agreed that we can create a separate procedure but I said we might be deleting some of the details/procedure mentioned there in P423 since we're now creating a 3rd level document control procedure indicating the step by step sequence of activities, that document should contain only the document control general requirements. Please enlighten me on this.
 
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G

gheghe

#2
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.
 
G

gheghe

#3
If I am a new document controller, and I was given a document, ie a Change notice, referrering to the above procedure, I don't know what the first thing to do.Please need your suggestion pals.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
gheghe,

I don't have time to read all of your posts, but here are a few quick comments:

Sounds like you are paying someone for a "canned" (generic) set of ISO documents. Is this the case?

You do not need to have a "level 3" work instruction or step-by-step document unless you feel there is a need. If you think the level 2 procedure and training is enough, that is okay. A general rule you find throughout these forums is "do what works best for YOUR situation".

Since it is late on Friday you may not get much response until next week. If you need quicker answers, I suggest you use the excellent search function here at the Cove to search for threads on "work instructions" and "procedures" and read them -- many questions you have might be there.

If you still have questions post again on Monday!
 

Al Rosen

Staff member
Super Moderator
#5
gheghe said:
If I am a new document controller, and I was given a document, ie a Change notice, referrering to the above procedure, I don't know what the first thing to do.Please need your suggestion pals.
Hi gheghe:

You can add a section describing the document change process. Perhaps a form is filled out describing the change, why the change is required and other information you think is necessary. This would document the change and could be part of the history. You could call it a Document Change Request.
 
G

gheghe

#6
Canned Package???!!

Honestly, I don't know that what we're using is one of tool quick starter kit from ISO Store until now. Because I thought that there documents were included when we bought the ISO standard and I thought that it is mandated by ISO, that's why I said "suggested procedure P-423". Its because this ISO co. rep. guy keeps on telling us that we can't "reinvent the will". We NEED a WI for document control that will tell us the "detailed HOW". I believed even if we have this canned packaged, we still have the descreation to modify it or even create the documents we actually need, I just don't know why this guy keeps us away from doin so. If I will be asked, I don't prefer canned packages, we can just use that as a guideline or reference but not to totally limit ourselves to what it suggest.
 
G

Greg B

#7
gheghe,

Welcome to the Cove. Sit back, relax and take a deep breath. :bigwave:

If your Doc Control Procedure/Work Instruction is electonic would you like to post it on this thread rather than type it out as you have done in this post?
Just go to 'Manage Attachments' (below the 'Reply to Thread' window) it will allow you to 'browse' for your document and then you can upload it. In that way we can see your document and you won't have so much typing.
I am a strong believer in telling people outside my company to leave our system alone or give me a REALLY good and sound reason why it must be changed (registrars and especially contractors included). If your company has hired an outside agency to write your system then they WORK for YOU. Tell them what you and your people want and don't accept things at face value, or take their word, make them prove it to you.
Remember, you can claim understanding of the process via Competency training as this can achieve the same results as the Work Instruction. For example, if everyone in the company is trained to understand how documents are produced and controlled then you may not require a work instruction. We don't have one. You WILL require a Procedure as the standard says that this is one of the six you require but this can be used in conjunction with training. You can use flow charts to show the path for control or the review of documents etc (whatever works for YOU). We have combined our Document Control Procedure and Record Control into one procedure because that is how WE want it. The rep might be trying to tell you that you have a system that works (By the way the saying is ....'Do not Reinvent the Wheel') and that you do not have to change much to conform to the standard. The level of the document that you have posted is probably a 'Procedure' and therfore a Level 2 document and with the addition of a 'Document Change' process as suggested by Mike it will probably suffice. Have you contacted your certifcation company and registrar and asked them about the Issue?

Remember, that if it comes down to getting a NC raised against this part of your system you can always fix it. It is not like you will never be certified. Everything is fixable. Is you company certified? If so how long? Or are you going for an upgrade to 9K2K?

PS: Go to the links at the bottom of this page or do a search on Document or records control in the forums and you will be swamped with excellent advice and examples. Here is an example of my Change Procedure. It is called a 'Continuous Improvement Suggestion' and wis part of my Doc Control & Records Procedure. I hope it helps.

http://elsmar.com/Forums/attachment.php?attachmentid=1843

Greg B
 
Last edited by a moderator:
G

gheghe

#8
ISO certified before..

(Remember, you can claim understanding of the process via Competency training as this can achieve the same results as the Work Instruction. For example, if everyone in the company is trained to understand how documents are produced and controlled then you may not require a work instruction. We don't have one).

Yes sir, I agree with that, but training here in not really as competent like yours, in fact I dont know if they have training in here. I never trained about their documentation procedures when I got here.(i wonder why they pass the certification before). Yes understanding, but what about consistency?

Thanks for the input regarding the attachment(I haven't tried attaching files before).The company has been ISO 9002 certified since 1996, and was upgraded to ISO 9001 in 1998, now they are planning to upgrade it to 2k. I'm new here, and from the very start I'm having a hard time doin my work because nobody trained me, nobody knows how to perform documentation activities ie BOM part# assignment/coding(not documented), the spec is too general. The system is always dependent on what they want to do now or what they want to say today(and changes every now and then). I know everything is fixable, that's what I'm trying to do here but, my problem is that they don't want to approved it. The reason they said "detailed specs is hard to comply and probability of non-conformity is too high".
 
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