SBS - The best value in QMS software

Sample Procedure from Contract Manufacturer Prospective

LUFAN

Involved In Discussions
#1
Hi everybody,

Risk is my not my particular area of expertise. That said, I am representing a contract manufacturer of consumables for a customer's main device, and I am wondering if anyone had a outline/procedure they might be able to share from the prospective of a CM rather than the manufacturer. I intend to write the procedure reduced in scope to the processes performed by us during product realization and not design, as we are not design responsible. I've read Rob Packard's article and gained some insight from that but still struggling a little bit to decipher 14971/24971 and pick out the areas important to a CM Risk Procedure.

Any help is appreciated.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
As a CM, you can't own the whole risk management process. Your customers (the "legal manufacturers") must own it as only they can establish risk acceptability criteria and they need to provide the clinical expertise to determine severity.

When we (we're a contract R&D shop specializing in medical device development) drive a Risk Management process for our clients, the CM usually is only involved in a Process FMEA. The CM can identify ways the assembly process can fail and the likely impact to the device but the legal manufacturer still has to be responsibility for establishing the severity. (Aside: the PFMEA is only where we use a detectability rating still.) The CM and legal manufacturer work together to establish suitable tests / inspections to mitigate the likelihood of the assembly failure.

If I were a CM, I'd write my risk management process to reflect that. Note that this should drive your client agreements.
 
Thread starter Similar threads Forum Replies Date
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
S 13485:2016 procedure sample ISO 13485:2016 - Medical Device Quality Management Systems 1
P Sample FDA compliant CAPA procedure wanted Document Control Systems, Procedures, Forms and Templates 2
S Sample QMS Procedure for Adaptation of New Product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Post Market Surveillance Sample Procedure for Medical Devices EU Medical Device Regulations 2
K Seeking a Sample Procedure for Handling Potentially Unsafe Food Products Food Safety - ISO 22000, HACCP (21 CFR 120) 1
H Dimensional Inspection Procedure - Sample wanted Document Control Systems, Procedures, Forms and Templates 2
M Customer Complaint Procedure Sample wanted Customer Complaints 6
B Software Beta Testing - Sample test plan or procedure wanted Other Medical Device and Orthopedic Related Topics 5
O Sample RoHS Compliance Procedure for plastic injection molding needed RoHS, REACH, ELV, IMDS and Restricted Substances 2
P General Production Procedure - Does anyone have a sample? Clause 7.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Sample Retention Requirements - Quality Records procedure - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
L Sample of Control of Document Procedure and Control of External Documents Document Control Systems, Procedures, Forms and Templates 2
S Decontamination of Customer Returned Product - Seeking sample procedure ISO 13485:2016 - Medical Device Quality Management Systems 8
H Preventive Maintenance - Does anyone have a sample of a PM procedure? Document Control Systems, Procedures, Forms and Templates 5
J Sample MDR and complaints procedure wanted - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Seeking: Process Change Control Sample Procedure / Help IATF 16949 - Automotive Quality Systems Standard 6
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
K How can Acceptance Number and Reject Number be larger than Sample Size on Z1.4 Table? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 1
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
S Determining sample sizes for PQ Qualification and Validation (including 21 CFR Part 11) 4
M Minimum sample size - Guidance and statistical rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 39
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
M Minitab assistant: 1-Sample % Defective Test Using Minitab Software 1
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
T ISO 27001 sample audit report IEC 27001 - Information Security Management Systems (ISMS) 0
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
T Sample of 1st Article Inspection Report wanted APQP and PPAP 3
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
B Determining sample size for device sterility Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
F Bayes Success run Theorem for sample size during OQ&PQ Qualification and Validation (including 21 CFR Part 11) 4

Similar threads

Top Bottom