Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality)

Graciel

Starting to get Involved
#1
Hello all,

I have one KPI that is being monitored since last september, called NC parts (maximum 3%.) The thing is, now it was verified that this KPI´s name should be FTQ (first time quality) since is actually being measured like it. And the target should increase (around 4% maximum). So, inside IATF and ISO 9001, the item 6.3 asks to verify 4 points before changing something in system management. So, can I just do one meeting minutes and register the risk analysis of this KPI change, also in the critical analysis report and do the review?
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
#2
Hello all,
So, can I just do one meeting minutes and register the risk analysis of this KPI change, also in the critical analysis report and do the review?
Good day @Graciel ;
I have good news. You're overthinking this, so it's much easier than you believe.

First let's speak to the terminology change.
Terminology change:
Your organization is wishing to change the term from "NC" to "FTQ". Not necessary, but if it make it easier to understand/more intuitive/is more accurate, then by all means change the term. IF this term is embedded within your management system (for example, IF you have a documented procedure or other method, which states something like....
"quarterly the 'XYZ team', will review the NC objectives to determine their suitability and the potential need to change",...
then your organization should employ whatever method of change management (i.e. "document control") you use to modify a controlled document. It certainly does not require a meeting UNLESS (heaven forbid) your procedure REQUIRES a meeting in order to update a document.


Next let's speak to the change to the objective (i.e. from max 3% to max 4%).
Objective "change":
This is not considered a change to the management system. This is simply an update to your organization's objectives. Objectives are intended to be frequently reviewed and updated as necessary. Your organization is free to update objectives (obviously there should be some understood and/or documented logic as to why the objective was updated), without the need to utilize some form of change management.

I hope this helps.
Be well.
 

Graciel

Starting to get Involved
#3
Good day @Graciel ;
I have good news. You're overthinking this, so it's much easier than you believe.

First let's speak to the terminology change.
Terminology change:
Your organization is wishing to change the term from "NC" to "FTQ". Not necessary, but if it make it easier to understand/more intuitive/is more accurate, then by all means change the term. IF this term is embedded within your management system (for example, IF you have a documented procedure or other method, which states something like....
"quarterly the 'XYZ team', will review the NC objectives to determine their suitability and the potential need to change",...
then your organization should employ whatever method of change management (i.e. "document control") you use to modify a controlled document. It certainly does not require a meeting UNLESS (heaven forbid) your procedure REQUIRES a meeting in order to update a document.


Next let's speak to the change to the objective (i.e. from max 3% to max 4%).
Objective "change":
This is not considered a change to the management system. This is simply an update to your organization's objectives. Objectives are intended to be frequently reviewed and updated as necessary. Your organization is free to update objectives (obviously there should be some understood and/or documented logic as to why the objective was updated), without the need to utilize some form of change management.

I hope this helps.
Be well.

Thanks !
I was worried because auditors could question item 6.3 (ISO 9001).
So from my understanding here, I will update during my next KPI review, which is done monthly by high management. And I always do Meeting minutes of it. So, I´ll register the reasons to modify and new target in it according to their review. Is it ok?
 

John C. Abnet

Teacher, sensei, kennari
#4
Thanks !
I was worried because auditors could question item 6.3 (ISO 9001).
So from my understanding here, I will update during my next KPI review, which is done monthly by high management. And I always do Meeting minutes of it. So, I´ll register the reasons to modify and new target in it according to their review. Is it ok?
Sounds like a good plan to me .

Be well.
 
Thread starter Similar threads Forum Replies Date
T Need help developing an ECO (Engineering Change order) procedure Document Control Systems, Procedures, Forms and Templates 3
V Do I need dimensionals performed for PPAP for every revision change? APQP and PPAP 2
V Note Change to Print - Do I need dimensions results? APQP and PPAP 1
K Need help with AS9100 Scope Change to include Manufacturing Process Maps, Process Mapping and Turtle Diagrams 1
V Do we need to enclose Draft version of Proposed Changes in Change Control US Food and Drug Administration (FDA) 8
E Change in the Expiration Date (from 24-36 months) - Need 510(k) changes? Other US Medical Device Regulations 10
G Change of procedure for handling new projects - do the ongoing ones need to follow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W Need to reconduct MSA when there is a change in operators? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L I need help with containment practices - First off/coil change containment Manufacturing and Related Processes 4
M Need advice to implement CAPP (Computer Aided Process Planning) change. Manufacturing and Related Processes 4
J Change Management System - Does ISO 9001 specify you need a process flow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Culture Shock and Things Need to Change - Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Need to change multi-site TS 16949 certification to add another company Registrars and Notified Bodies 4
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
C Controlled EC's - Need some advice on my current Engineering Change process IATF 16949 - Automotive Quality Systems Standard 2
J If you change the Control Plan do you need to resubmit PPAP APQP and PPAP 13
D Need to get ISO recertified for a site change, but just near to the original site? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Do I need to change my SOPs? Transitioning to ISO 9001:2000 from the 1994 version ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Change History: What Documents Need a History? Document Control Systems, Procedures, Forms and Templates 34
E Procedure Numbering Change? Still the need for maintaining Level 1, 2, 3, documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Change the way we need to document our work - Copies of requirements? QS-9000 - American Automotive Manufacturers Standard 2
B PPAP and the need to re-submit - Engineering change to a single component part QS-9000 - American Automotive Manufacturers Standard 1
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
W Need for current design or process control FMEA and Control Plans 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3

Similar threads

Top Bottom