What goes into a Control Plan?

F

FlackUK

Hi all,

Recently been moved into a new area of business, and been tasked with implementing the TS 16949 management system. Now, I have had ISO 9001 experience, and ISO 14001 experience in management systems in the past, but this TS 16949 malarkey is blowing my mind!

I am trying to understand Control Plans at the moment, and how to satisfy the requirement of Clause 7.5.1.1. and and trying to get my understanding right.

We are a wheel & tyre assembly (all we do is put alloy & wheel together and send to customer).
Am I right in thinking all the Control Plan needs to do is contain all the SOP's, WI's and Engineering Controls within a table in the format of headings from Annex A of the TS16949 standard?

Hope someone can clarify!
Have so much to try and take in!

Kind Regards, Charlie
 
A

AndyN

Moved On
FlackUK said:
Hi all,

Recently been moved into a new area of business, and been tasked with implementing the TS 16949 management system. Now, I have had ISO 9001 experience, and ISO 14001 experience in management systems in the past, but this TS 16949 malarkey is blowing my mind!

I am trying to understand Control Plans at the moment, and how to satisfy the requirement of Clause 7.5.1.1. and and trying to get my understanding right.

We are a wheel & tyre assembly (all we do is put alloy & wheel together and send to customer).
Am I right in thinking all the Control Plan needs to do is contain all the SOP's, WI's and Engineering Controls within a table in the format of headings from Annex A of the TS16949 standard?

Hope someone can clarify!
Have so much to try and take in!

Kind Regards, Charlie
Click to expand...

Charlie: How are things in sunny Britain?

Typically, the Control Plan comes from a) the Process Flow and b) the Process FMEA. Have you got these? It's difficult, even with a simple wheel/tyre mounting job, to do the CP without them.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Dobby1979 Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
S Gauge R and R - Product - Conveyor belt with threads that goes on Sprocket Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
D Is it okay to CE mark the product until the RoHS2 directive goes into effect? CE Marking (Conformité Européene) / CB Scheme 7
A Personal names in docs - Goes against every documenation practice I know! Document Control Systems, Procedures, Forms and Templates 30
ScottK FDA Listing a Class I that goes into a Class II 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L To share or not to share? Work distribution when someone goes on vacation Quality Manager and Management Related Issues 19
T Calibration Laboratory Temperature/Humidity goes out of tolerance due to Power Loss General Measurement Device and Calibration Topics 9
R Should the fault tests pass if temperature goes high in short time? IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
B UV Tunnel Conveyer for Sterilization before my Raw Material goes in Production? Food Safety - ISO 22000, HACCP (21 CFR 120) 8
K When to do Final Release if Medical Device goes off site prior to shipping? ISO 13485:2016 - Medical Device Quality Management Systems 5
L AIAG CQI 15 Audits - Looking for the excel worksheet that goes with it Process Audits and Layered Process Audits 4
Wes Bucey What to think when a major manufacturer goes off the Quality track? US Food and Drug Administration (FDA) 3
R Does IVD 510k application always goes to pre-IDE and IDE process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Unscheduled Maintenance - Product Impact when a machine goes down ISO 13485:2016 - Medical Device Quality Management Systems 16
M Customer Complaint vs. Repair - Unit goes out of specification after the warrenty Customer Complaints 8
A Riddle - What goes up and down the stairs without moving? Brain Teasers and Puzzles 2
G Until where goes ISO TS 16949 for Suppliers ? IATF 16949 - Automotive Quality Systems Standard 1
ScottK What exactly is a "Process of Record" and what goes into it? Document Control Systems, Procedures, Forms and Templates 5
H What do you do when a part goes Obsolete and How do you Initiate such a Process? Document Control Systems, Procedures, Forms and Templates 7
Q What is a manufacturing plan? What goes into a manufacturing plan? Various Other Specifications, Standards, and related Requirements 19
CalRich Subcontracted laboratory per 5.10.6 - Whose name goes on the Calibration Certificate General Measurement Device and Calibration Topics 1
C Certification Release - Certification goes out to a customer and there is a mistake General Measurement Device and Calibration Topics 1
A Cable Uptime - TV goes out but Cable Modem works After Work and Weekend Discussion Topics 3
I Integrating CAPA and Change Control processes ISO 13485:2016 - Medical Device Quality Management Systems 3
A Can a Form Template be altered in a 13485 document control system? ISO 13485:2016 - Medical Device Quality Management Systems 4
R ILAC G24 - defining process control measures, ISO 17025 related Discussions 2
MaHoDie How deep should be risk control tracebility IEC 62304 - Medical Device Software Life Cycle Processes 3
S Control of Drawings in Production Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T OTS (Off-the -Shelf) Software involved in error control and messaging US Food and Drug Administration (FDA) 1
D Control Limit Calculation with multi-cavities molding Statistical Analysis Tools, Techniques and SPC 5
G Clause 8.5.1 -- Is non Identification evidence of ineffective control of production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
J Document Control Requirements within Oracle System Document Control Systems, Procedures, Forms and Templates 1
Q IATF / AIAG: Control Plans and CC / SC requirements FMEA and Control Plans 4
Ashland78 IATF Process Control Plans not including customer name Manufacturing and Related Processes 13
M What should be measurement method in control plan if you are defining Control method as work instruction. Manufacturing and Related Processes 5
G Help Needed: Quality Control / Assurance process Quality Manager and Management Related Issues 3
T Document Approver System AS9100 Doc Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Terms & Conditions Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G Control of Externally Provided Processes, Products, and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Crimpshrine13 Bulk Process (Electroplating), Control Plan, and Process Change IATF 16949 - Automotive Quality Systems Standard 1
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Introducing a document control system benefits Document Control Systems, Procedures, Forms and Templates 13
N Effective use of a Risk Register - Bumper sticker or Mission Control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
L To control the essential design outputs Medical Device and FDA Regulations and Standards News 4
G Root cause for outsourced pest control service not in approved supplier list ISO 13485:2016 - Medical Device Quality Management Systems 4
A Digital Document Control - Revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
O Process Flow Diagram, DFMEA, PFMEA, Control Plan integrated softwares FMEA and Control Plans 7
V Over 60 dimensions CMM measurement in control plan APQP and PPAP 8
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
V Opinion on gauge control graphic General Measurement Device and Calibration Topics 5

Similar threads

Top Bottom