Control and Identification of ISO/TS 16949:2009 Documentation.

M

mohamedhrr

#1
Hello,

we are auto parts manufacturing company and going for TS certification.
I am being given the responsibility of handling documentation.
Kindly help me in achieving my goal, I have some doubts.

Appendix-Quality manual.
Control regulation of regulations.
Control regulation of Engg Documents.
Control regulation of Records.
Regulation of Quality Control.
Conrol Regulation of Quality Training.

Above are some of the regulations in our manual.
In each of these regulations, there are N number of documents related to the regulation.(example-in control regulation of Engg documents-documents listed are work instructions, quality check standard, one point lesson, external document receiving record, external document control sheet)
My question is:
1.All these documents are available in Manual
Master copy of all these documents should be maintained separately in master list.
OR Its enough if it is available in the manual.
2.All these documents have been allotted a table number in manual.
Can we use the same table number or else a separate number should be allotted to these documents.

If my questions are clear and understood.

Please HELP.
:thanx:
 
Elsmar Forum Sponsor
L

lk2012

#2
Hello,
I'm not quite sure from your post how your QMS is organised so let's just start with a simple question:
is your QMS structured along with the pyramid?
meaning:
1. top level... Quality Manual only (smallest number of documents, sometimes just one)
2. procedures... all your regulations / procedures for your processes (stating who's responsible for what, how the process works, what are the inputs and outputs. make sure you cover all the mandatory ones by TS)
3. instructions ... these are instructions describing how to do the different steps in the process you described in level 2 (example: procedure is for Engineering change, instruction is how to fill in your Engineering Change document correctly)
4. forms ... these are all your templates / blank forms which you use to do the things you described in your procedures (example: procedure is for Engineering change, instruction is how to fill in your Engineering Change document correctly, use form no. F-1)

All your quality alerts, FMEAS, Control Plans etc are not parts of your QMS as such. Only their templates are and procedures referring to them and instructions how to fill them in.

Hope this helps.
Lil
 

John Broomfield

Staff member
Super Moderator
#3
Hello,

we are auto parts manufacturing company and going for TS certification.
I am being given the responsibility of handling documentation.
Kindly help me in achieving my goal, I have some doubts.

Appendix-Quality manual.
Control regulation of regulations.
Control regulation of Engg Documents.
Control regulation of Records.
Regulation of Quality Control.
Conrol Regulation of Quality Training.

Above are some of the regulations in our manual.
In each of these regulations, there are N number of documents related to the regulation.(example-in control regulation of Engg documents-documents listed are work instructions, quality check standard, one point lesson, external document receiving record, external document control sheet)
My question is:
1.All these documents are available in Manual
Master copy of all these documents should be maintained separately in master list.
OR Its enough if it is available in the manual.
2.All these documents have been allotted a table number in manual.
Can we use the same table number or else a separate number should be allotted to these documents.

If my questions are clear and understood.

Please HELP.
:thanx:
mohamed,

Are you calling your documented procedures "control regulations"? If so, why?

Each of your management system documents is subject to revision. Therefore assign a unique document code to each document. You can then control each document separately as these documents will be revised at different times and you want to provide employees with information they can rely on.

The original (if this is what you mean when you say "master copy") is normally held electronically, in a separate folder on the computer system, by the System Manager or Management Rep.

You may choose to keep a master list of the documented parts of your management system so you can inform users (of hardcopy documents) what version they should be using or you can make the documents only available electronically, in which case you do not need to keep a master list up to date.

Your manual describes your management system and it comprises documents reproduced and issued from the originals. Besides its document code you may choose to number each page n of N where N = the total number of pages. Exhibits in the back of the manual can be controlled separately as these may change more frequently that the description of the management system itself.

I'm intrigued to know what your "control regulations" are.

John
 
M

mohamedhrr

#4
Control regulation is the control over the documented procedures.
Example- Disposition of Quality records, disposition of electronic media, Quality record list of dept.these are the documented procedures under Control Regulation of Records.
Formats of these documented procedures are available in the manual under Control regulation of records.
My question is whether a separate list of documented procedures(formats) under all the control regulations should be maintained separately OR is it enough if it is maintained in the manual under particular control regulation.

thanks
 

John Broomfield

Staff member
Super Moderator
#5
Control regulation is the control over the documented procedures.
Example- Disposition of Quality records, disposition of electronic media, Quality record list of dept.these are the documented procedures under Control Regulation of Records.
Formats of these documented procedures are available in the manual under Control regulation of records.
My question is whether a separate list of documented procedures(formats) under all the control regulations should be maintained separately OR is it enough if it is maintained in the manual under particular control regulation.

thanks
mohamed,

You're welcome.

I see now that your "Control Regulation of Records" is my Filing and Archiving. In a process-based management system you may find it better to name your documented procedure for the process it specifies.

You may agree that it would be better for your leaders to show their respect for users and commitment to the procedures by their behaviors instead of giving the documents authoritative (off putting) titles.

Where in the documented part of your management system you choose to specify the way to carry out the processes for controlling documented information is up to you. Personally, I provide an overview of these processes in the manual and refer to two documented procedures for the control of documented information:

  • Controlling documents that are subject to revision
  • Filing and archiving records
A. is flowcharted and B. is a spreadsheet.

These reason for this is as I stated in my post above. You need to be able to update system documents quickly so users can rely on their management system to help them to determine and meet requirements. Keeping up with the changes is a lot easier with separate documents than with one thick manual.

Or, when you are ready, you could establish a wiki for helping everyone to use and improve their management system documentation. Search Elsmar Cove for wiki postings by my friend Pancho.

John
 
Thread starter Similar threads Forum Replies Date
N ISO 14001 Control vs. Influence - Environmental Aspects Identification ISO 14001:2015 Specific Discussions 6
T Identification and Control of External Documents - 4.4.5 f) of ISO 14001 ISO 14001:2015 Specific Discussions 5
M Shelf Life Control and Identification of items that do not have Shelf Life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Hazard Identification for Pest Control Activities Other ISO and International Standards and European Regulations 9
M Document Identification and Control Numbers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Changing Document Control Identification of Job Descriptions Document Control Systems, Procedures, Forms and Templates 5
C Control, Identification and Content of Corporate Electronic Forms Document Control Systems, Procedures, Forms and Templates 7
V Identification & Control - Documents of External Origin - ISO13485:2003 Clause 4.2.3f Document Control Systems, Procedures, Forms and Templates 8
M Identification and Control of Hard-to-label Product - 1/8" diameter ROD ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R TS 16949 - Clause 4.2.3 - Identification and Control of Documents of External Origin IATF 16949 - Automotive Quality Systems Standard 15
F Documents of External Origin - Identification, Control and Distribution - 4.2.3 f) Document Control Systems, Procedures, Forms and Templates 13
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 2
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 7
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Attributes SPC study - Attributive control (Go gage) Statistical Analysis Tools, Techniques and SPC 5
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
D Infrastructure: Equipment, Work Environment and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J How to make Quality Control plans Quality Tools, Improvement and Analysis 5
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
J Antiviral Mask or Mask to Mitigate or Control Corona Virus Manufacturing and Related Processes 29
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom