What is the function of the Critical Component List?

MDD_QNA

Involved In Discussions
What is the function of the critical component list? How does it serve in different departments?

Is it a requirement coming from the ER? Or the CB testing and hence 60601-1? I couldn't find any good information in 60601-1. Can someone point me to the right standard or in the reight direction?
Thanks!
 

Mark Meer

Trusted Information Resource
Good question. I've wondered the same. Though not explicitly in the 60601-1 standard, all CB test reports have the list.

Which leads me to believe it has something to do with the CB scheme or NRTL certification - its purpose being strictly for inspections. It is a convenient "short list" of the most important components that certification bodies can use to confirm production controls are adequately maintained during their surveillance inspections.

I may be wrong, but this appears to be its use in practice.
 

Peter Selvey

Leader
Super Moderator
There are three drivers for the list:

One is a basic ISO 17025 requirement that the test records have enough detail to be able to re-produce the result (e.g. if challenged, or design update etc). This is done through identifying manufacturer, make/model, serial number, photos and critical parts list, circuit diagrams, spec sheets for certain parts and so on.

The second is that IEC standards normally have a clause that requires certain parts to be certified components, and some clauses also make reference to specific attributes. A list of critical components helps to provide evidence of meeting these requirements (in the body of the report, you can just say, see the critical component list, rather than listing each part in the relevant clause).

The third is that if product certification is involved, the factory inspectors will use this list (and the photos, spec sheets etc) to confirm the product has not changed. The most popular by far is NRTL but there are other schemes.

None of this should imply parts listed are special in the sense only changes to those parts trigger retesting or evaluation.

Regardless of what is on the list, for the manufacturer any design change should trigger at least an internal re-evaluation of standards compliance, which might range from a single sentence - "obviously no effect" - through to detailed re-testing.

If the device is under product certification, a separate decision has to be made whether to report the change to the agency. The list might influence the decision, but keep in mind other changes can also trigger re-evaluation (for example, a software change or "non-critical" secondary part change might influence transformer loading).

For CB reports, there is no obligation to report changes. CB reports are only a stepping stone to product certification. They keep the lists also with an eye to facilitate the eventual certification process/factory inspections. But strictly speaking this is not the real list used for product certification.
 
Thread starter Similar threads Forum Replies Date
S Critical to manufacturing but not product function - Non-conformance or Not? Nonconformance and Corrective Action 12
Q Definitions of Function in PFMEA ISO 14971 - Medical Device Risk Management 2
B Support function definition IATF 16949 - Automotive Quality Systems Standard 12
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
W Pfmea function requirement and failure mode FMEA and Control Plans 6
P Search function minimum length Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
K Multiple function device products EU Medical Device Regulations 0
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
K Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 2
T Spirometer - Pulmonary Function Testing - ATS/ERS:2005 EU Medical Device Regulations 5
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C Function definition for DFMEA FMEA and Control Plans 1
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
C FMEA - Multiple function failures considerations FMEA and Control Plans 3
S Status products when/if the QMS ceases to function? EU Medical Device Regulations 1
M New Medical Device Accessory with New Function - Is this a major change? Other Medical Device Regulations World-Wide 3
W Is sharing resources treated same way as remote function? IATF 16949 - Automotive Quality Systems Standard 1
H Conveying Form Fit and Function Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
G Function in french called "numbre de posage(s)" - CMK Question Quality Tools, Improvement and Analysis 3
M Remote Office only has Invoice Function - Audit Needed? IATF 16949 - Automotive Quality Systems Standard 0
J FAI per AS9102 affecting Fit, Form, Function AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Cross Function Process Map for Document Control Process Maps, Process Mapping and Turtle Diagrams 3
F Which Business Function should Approve Suppliers and maintain the ASL Supplier Quality Assurance and other Supplier Issues 8
L How to Introduce the Quality Function to the production floor in a bad environment Misc. Quality Assurance and Business Systems Related Topics 6
A ISO 27001 function wise or department wise audit questionnaire with control & clauses IEC 27001 - Information Security Management Systems (ISMS) 3
M Taguchi Loss Function Problem Misc. Quality Assurance and Business Systems Related Topics 2
C IVDD 98/79/EC Measuring Function Requirements EU Medical Device Regulations 2
N Regulatory and Safety Standards for Medical Device with Measuring Function IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
M Where to start Maintenance Function Kaizen Lean in Manufacturing and Service Industries 4
L Remote Control Inspection Digital Indicator with a TIR (range) function Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J CE Mark Classification for a a pulmonary function test filter CE Marking (Conformité Européene) / CB Scheme 2
S Outsourcing PPAP Function APQP and PPAP 8
F What is an FAA PAI Maintenance Function List? Federal Aviation Administration (FAA) Standards and Requirements 3
Z Scope of Employee and Function Levels of Internal Audits Internal Auditing 3
T Difference between the terms Function & Process when used in Construction Management Business Continuity & Resiliency Planning (BCRP) 12
N Role of Quality Function in Approving Work Instructions Document Control Systems, Procedures, Forms and Templates 4
C What can you do if Quality is treated as a separate function in an organization? Quality Manager and Management Related Issues 24
V Annual Performance Appraisal - Person vs. Function/Business Career and Occupation Discussions 5
B Which type of DOE was likely used for this transfer function? Six Sigma 4
A Function for Effects - Beginner in usage of the IQRM FMEA and Control Plans 3
P Nonlinear Fit for a Complicated Curve - Fitting a Function to the Data Statistical Analysis Tools, Techniques and SPC 6
V SOPs and Internal Audit Criteria for Regulatory Affairs (Submissions Function) US Food and Drug Administration (FDA) 4
V What kind of Data should support Fit/Function Characteristics? APQP and PPAP 1
S Probability Density Function of a Function of a Random Variable Statistical Analysis Tools, Techniques and SPC 13
J Definition Form Fit or Function - Materials Composition and Manufacturing Processes? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Function of a Change Number in our ECN / document vault program as a tie-in Problem Solving, Root Cause Fault and Failure Analysis 3

Similar threads

Top Bottom