Control of "manufacturing material" that has adverse effect on the medical device?

P

pangchiaboon

#1
Dear Sir,
FDA part 820 talk has the requirement on the control of "manufacturing material" that has adverse effect on the medical devices. May i know what are the minimum controls that normally practice by orthopedics medical device manufacturers that can still comply to regulation? Below are some controls that we are practicing now:
  • Only use manufacturing material approved by customer.
  • Only purchase manufacturing material from customer approved suppliers.
  • Only purchase the manufacturing material from approved suppliers.
  • Only purchase approved manufacturing material.
  • Conduct receiving inspection for manufacturing materials.
  • Only use accepted manufacturing material for manufacturing processes.
  • Conduct internal audit to confirm the compliance of the above.

Do you think this is sufficient?

There are some gaps in our system, for example not all manufacturing materials are subjected to receiving inspection, some manufacturing materials are not always purchase from the same approved supplier etc. These manufacturing materials normally are off-the-shelf materials like polishing consumables, do you think this is a problem?

Please share the industrial practice. Thank you.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Control of "manufacturing material" that has adverse effect on the medical device

Dear Sir,
FDA part 820 talk has the requirement on the control of "manufacturing material" that has adverse effect on the medical devices. May i know what are the minimum controls that normally practice by orthopedics medical device manufacturers that can still comply to regulation? Below are some controls that we are practicing now:
  • Only use manufacturing material approved by customer.
  • Only purchase manufacturing material from customer approved suppliers.
  • Only purchase the manufacturing material from approved suppliers.
  • Only purchase approved manufacturing material.
  • Conduct receiving inspection for manufacturing materials.
  • Only use accepted manufacturing material for manufacturing processes.
  • Conduct internal audit to confirm the compliance of the above.

Do you think this is sufficient?

There are some gaps in our system, for example not all manufacturing materials are subjected to receiving inspection, some manufacturing materials are not always purchase from the same approved supplier etc. These manufacturing materials normally are off-the-shelf materials like polishing consumables, do you think this is a problem?

Please share the industrial practice. Thank you.
Can someone help?

Thank you very much!

Stijloor.
 

yodon

Staff member
Super Moderator
#3
Re: Control of "manufacturing material" that has adverse effect on the medical device

I'd say it's sufficient if it's working. Hard to say otherwise.

You might want to consider doing a risk analysis on all the materials. Ask what if the incorrect material is used (what adverse events could occur, etc.). For those that pose the most risk if they aren't well controlled, you'll want to apply the highest level of control.

I would think that not purchasing manufacturing materials from an approved supplier would be a risk and possibly a process non-conformance. How would you ensure you're getting the right stuff? How would you ensure that the substitute material supported the validated process correctly? If there are several suppliers, ensure they are qualified and approved.
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
N Nonconforming Material (NCM) Control in very Small Manufacturing Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
H Quality Management and Quality Control - Manufacturing company of 40+ people Quality Manager and Management Related Issues 1
J Using P-Charts for Glass Manufacturing to Monitor and Control Attributes Statistical Analysis Tools, Techniques and SPC 2
Chennaiite Control Chart for Non-Manufacturing Process Indicators - Is it worth? Statistical Analysis Tools, Techniques and SPC 1
B Production Control and Traceability - Manufacturing Fishing Vessel Deck Machinery Manufacturing and Related Processes 6
Q How to Control Hold Points in Manufacturing? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Sulfur and Environment - Cattle Feed Manufacturing Snake Control Miscellaneous Environmental Standards and EMS Related Discussions 10
M Quality Control Reporting to Manufacturing - Conflict of Interest Quality Manager and Management Related Issues 6
H Seeking opinion on Control of Manufacturing of Medical Devices (Printers) Records and Data - Quality, Legal and Other Evidence 2
A Traceability and Control of Manufacturing Lots IATF 16949 - Automotive Quality Systems Standard 7
A From Quality Assurance to Quality Control and Manufacturing to Non-manufacturing Career and Occupation Discussions 17
P Pest Control procedure for a manufacturing facility. ISO 13485:2016 - Medical Device Quality Management Systems 3
M SPC (Statistical Process Control) analysis and status on two manufacturing plants Statistical Analysis Tools, Techniques and SPC 4
S Difference between control & audit - Cleaning manufacturing equipment Internal Auditing 5
G Manufacturing -> Warehouse -> Tier 1/OEM - Process flow, PFMEA, & Control Plan FMEA and Control Plans 9
jkuil Manufacturer control over third party design and manufacturing? Design and Development of Products and Processes 3
M Information about Manufacturing Process Self Control and its potential risks Quality Tools, Improvement and Analysis 3
T Control of delinquent gages within a manufacturing organization General Measurement Device and Calibration Topics 4
J Examples and help for non-manufacturing control plans FMEA and Control Plans 7
N Document Control in Manufacturing - Machine Setup Sheets Document Control Systems, Procedures, Forms and Templates 9
S Environmental Control Standards - Sterile medical device manufacturing environment ISO 13485:2016 - Medical Device Quality Management Systems 3
L Manufacturing and quality control process in furniture production company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3

Similar threads

Top Bottom