SBS - The best value in QMS software

Linking Control Plans and PFMEA's

#1
I am looking for evidence in the IATF standard or the AIAG handbook that tells me that my controls from my PFMEA need to happen in the same operation as they do in the control plan. Basically, I have identified all my failures from a certain operation step in my FMEA where the failure is actually occurring. I cannot check or detect those failures until later on in the process. I have called out the attribute gauging at a later stage in my control plan and not in the steps that the failures are created and listed in my PFMEA. Auditor thinks my control plan should be calling out the control during those steps and not when it is actually happening and is using "line for line" literally. I interpret the standards to be "line for line" meaning we control all lines in the FMEA at some point in the control plan. If not, what is the "detect post processing" for in relation to the detection on the FMEA. I need the evidence from the standard to help prove my case. Please and thank you
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
Staff member
#2
I am looking for evidence in the IATF standard or the AIAG handbook that tells me that my controls from my PFMEA need to happen in the same operation as they do in the control plan. I need the evidence from the standard to help prove my case. Please and thank you
Good day @TJ ;
The question I believe you should be asking instead is...where is the requirement (implied/stated by the auditor) that the sequence/numbering on the control plan and those PFMEA must "match" ?

There is no such requirement. In fact, within the AIAG/VDA harmonized PFMEA approach, the AIAG has finally embraced/promotes family/foundation PFMEA. When such is applied, it is even more unlikely that the PFMEA and Control Plan sequence/numbering will match.

The INTENT of the PFMEA is to identify the potential failure modes and their risks.
The INTENT of the control plan is to identify (as the name implies) the process controls, including commensurate with the risks identified in the control plan.

If this is done, then your auditor needs to define the "problem" he or she is alluding to.

Hope this helps.
Be well.
 
#4
Hello,

I think as the Control plan must be in line with PFMEA , the product and process characteristic which are defined in the PFMEA must be in the control plan. For users by soft (APIS, IQS, etc) are more easily understand this requirement because the soft can be offer this opportunity. For Excel or other tools which are not have possibility link the PFMEA with Control Plan is difficulty for understand and put in practical. So, not all functions from PFMEA will be control (added ) I the Control plan, just product characteristic and process characteristic with Special characteristic where is case. The Control plan have the 3 parts (Incoming, Manufacturing and Monitoring & control).
 
Thread starter Similar threads Forum Replies Date
M Linking Process Flow Charts, FMEAS and Control Plans for TS 16949 FMEA and Control Plans 4
E Linking of Process Control Plans To Process Documentation FMEA and Control Plans 6
T Software for linking Process Flow Diagram, Process FMEA and Control Plan APQP and PPAP 9
B Control of Documents in several languages and Document Linking ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Linking: Process Flow - 'Common' Process FMEAs - Control Plan FMEA and Control Plans 11
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
F Linking customer claims to FMEA IATF 16949 - Automotive Quality Systems Standard 3
M Linking Risk Management with Lessons Learned ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Linking the FMEA Causes & Action Plan with DOE Experiments or Experimentation Design FMEA and Control Plans 1
S Linking CARS (Corrective Action System) with the rest of our system Nonconformance and Corrective Action 4
A FMEA - Linking Customers Complaints to an FMEA and Update ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Linking Procedures to ISO 17020 Clauses General Measurement Device and Calibration Topics 3
R Linking a Gage Manufacturer by Serial Number Quality Manager and Management Related Issues 5
B Linking Quality Plan Objectives to the Business Plan? IATF 16949 - Automotive Quality Systems Standard 7
N Linking Business Process Map with Sub-Process Process Map Process Maps, Process Mapping and Turtle Diagrams 39
N Linking BSC (Balanced Score Card) with Six Sigma Six Sigma 18
C Linking Acceptable Quality Levels (AQL) and Average Output Quality AQL - Acceptable Quality Level 7
D Hyperlinks in Microsoft Excel and Word - Linking Documents Excel .xls Spreadsheet Templates and Tools 12
A Linking ISO 9000 to Economic Value Added ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
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
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
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0

Similar threads

Top Bottom