Rolling out Control Plans

R

ratoth

#1
Hi All, this is my first post so thank you ahead of time for your feedback. I work in a Machine Shop that is an internal supplier for a medical device company. I've been given the task of developing and launching control plans for the shop. My question is kind of a difficult one (IMO) to phrase but I'll try: does anyone have advice/examples on what development(example: document control, IT, logistics, infrastructure) outside of PFMEAs/Process flow charts is required to put Control Plans in place? I'm expected to take us from zero to sixty by this time next year and we have no applicable precedent in our division to follow. On the good side, I have solid management support.

Thanks again for your feedback!:thanks:
 
Elsmar Forum Sponsor
U

Umang Vidyarthi

#2
Hi All, this is my first post so thank you ahead of time for your feedback. I work in a Machine Shop that is an internal supplier for a medical device company. I've been given the task of developing and launching control plans for the shop. My question is kind of a difficult one (IMO) to phrase but I'll try: does anyone have advice/examples on what development(example: document control, IT, logistics, infrastructure) outside of PFMEAs/Process flow charts is required to put Control Plans in place? I'm expected to take us from zero to sixty by this time next year and we have no applicable precedent in our division to follow. On the good side, I have solid management support.

Thanks again for your feedback!:thanks:
Hello ratoth, :bigwave:Welcome to the Cove:bigwave:

There is plenty of material on 'Control Plans' on the Cove.

hope this helps

Umang :D
 
Thread starter Similar threads Forum Replies Date
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
F EU MDR 2017/745 Rolling Plan Medical Device and FDA Regulations and Standards News 4
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
C Rolling the correct M8 1.25 Pin Thread Manufacturing and Related Processes 2
B Implementing and Rolling Out a Kanban System to Dictate our Scheduling Lean in Manufacturing and Service Industries 3
S Rolling out a Revised Quality Manual to all the Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B 8D Evaluation Help? Rolling Out 8D Evaluation Training to a Team Nonconformance and Corrective Action 5
R Thread Rolling on 316 Stainless Steel - What Process is Best? Manufacturing and Related Processes 5
D Using electronic lab notebooks in the design control process ISO 13485:2016 - Medical Device Quality Management Systems 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 13
D How to calculate the A4 constants in Median/Range control charts? Statistical Analysis Tools, Techniques and SPC 1
Nihls Quality Control Card for CMM's Capability, Accuracy and Stability - Processes, Machines, etc. 0
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
Sonja D AIAG VDA PFMEA and Control Plan training FMEA and Control Plans 6
F Quality Control in Electrical Calibration ISO 17025 related Discussions 0
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
D Computer access, password control ISO 13485:2016 - Medical Device Quality Management Systems 6
A How to control distribution list? Document Control Systems, Procedures, Forms and Templates 2
A Control plan for IATF - example? FMEA and Control Plans 1
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Final quality control corrective actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
D Use Error Risk Controls and Control Verification ISO 14971 - Medical Device Risk Management 6
S Maintenence related action in Control plan FMEA and Control Plans 3
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
R Control Methods in Control Plan FMEA and Control Plans 5
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 14
S TSCA (Toxic Substances Control Act) PIP 3:1 RoHS, REACH, ELV, IMDS and Restricted Substances 0
S Use of Attributes Control Charts Statistical Analysis Tools, Techniques and SPC 1
U Appraiser Out of Control Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
Z AS9100 Control of Nonconforming Outputs - Rework Dispositions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
J Warehouse temperature and humidity control EU Medical Device Regulations 7
Jimmy123 IATF16949 Control Plan FMEA and Control Plans 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 1
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom