Requested Validation plan and reports

junior1505

Starting to get Involved
#1
Greetings of the day.
We are one of the manufacturers of Hot and Cold Forged components.
Recently, we have been enlightened by some experts here about the Control plan that we need to devise and has helped a lot.
One of our customer and a third party certification body has asked me to prepare and submit the following.
1. Validation plan and report.

As a production guy, we are confused as to which of the below cited to be determined, tabulated, implemented and monitored.
1. Production Validation Plan and Report.
2. Process Validation Plan and Report.

Can anyone help and guide me with any documentation, so that we can establish the process at our end. As per our understanding, the component produced as per drawing and specification itself is the product/component validation of the component and Die/Tooling.
Request your view and opinions and the guidance.
 
Elsmar Forum Sponsor

atitheya

Quite Involved in Discussions
#2
Insufficient information.

In what context have they raised such a requirement? What is the evidence for such a finding? What standard are you being audited against?

In case of ISO9001:2015

If you design your products, you will need to perform validation activities in accordance with -
8.3.2 c) the required design and development verification and validation activities - Validation plans, and,
8.3.4 d) validation activities are conducted to ensure that the design and development outputs meet the requirements for the specified application or intended use - Validation records / reports.

Away from design, some processes may need validation and re-validation -
8.5.1 f) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.

These processes could be
One or more of your production processes,
One or more of your service processes, such as delivery, or any other, as the case may be.

You need to have a plan for such validation and re-validation and then the validation records / report.

If you are following any other standard, then relevant clauses of that standard will apply.
 

DuncanGibbons

Involved In Discussions
#3
Greetings of the day.
We are one of the manufacturers of Hot and Cold Forged components.
Recently, we have been enlightened by some experts here about the Control plan that we need to devise and has helped a lot.
One of our customer and a third party certification body has asked me to prepare and submit the following.
1. Validation plan and report.

As a production guy, we are confused as to which of the below cited to be determined, tabulated, implemented and monitored.
1. Production Validation Plan and Report.
2. Process Validation Plan and Report.

Can anyone help and guide me with any documentation, so that we can establish the process at our end. As per our understanding, the component produced as per drawing and specification itself is the product/component validation of the component and Die/Tooling.
Request your view and opinions and guidance.
I would develop a process control document, clearly depicting the process diagram for the standard hot and cold forging process and PFMEA for identification of risks and how you mitigate these. This essentially is your process validation plan. As for the report, this will consist of previous components manufactured on said process involving your SPC and MSA to prove the process is in control.

For the component validation plan, this will be your manufacturing plan clearly depicting all the steps involved in producing the specific part in question (including testing and inspection). The output of which is essentially a certificate of conformance.

PS this is my two cents, Im sure the more experienced members can correct me or provide additional info.
 

kuyakut

Involved In Discussions
#4
Greetings of the day.
We are one of the manufacturers of Hot and Cold Forged components.
Recently, we have been enlightened by some experts here about the Control plan that we need to devise and has helped a lot.
One of our customer and a third party certification body has asked me to prepare and submit the following.
1. Validation plan and report.

As a production guy, we are confused as to which of the below cited to be determined, tabulated, implemented and monitored.
1. Production Validation Plan and Report.
2. Process Validation Plan and Report.

Can anyone help and guide me with any documentation, so that we can establish the process at our end. As per our understanding, the component produced as per drawing and specification itself is the product/component validation of the component and Die/Tooling.
Request your view and opinions and the guidance.
1. Validation Plan -is how you will validate your whole process
2. Process Validation Plan is more appropriate since you are validation your process flow.
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#5
I assume you should include some metrics to provide indicators for the validation. If you do need help there, I have a lot of Statistical Process Control methodology here in the Cove library. Also, I do have some basic knowledge of forging between my father was a foundryman (and I spend some time visiting foundries shall we say) and experience with engineering on nuclear submarines. So if you want to discuss off line more than happy to assist.
 
Thread starter Similar threads Forum Replies Date
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 8
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
dubrizo IATF 16949 Clause 8.7.1.6 - Customer Notification - Your Inputs Requested IATF 16949 - Automotive Quality Systems Standard 4
dubrizo Clarification Requested in 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Suggestions requested on handling batch record papers exposed to hormonal products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Auditor has requested that the granite table in the lab be Calibrated Calibration and Metrology Software and Hardware 19
M Reducing Cost of Poor Quality - Your opinion requested Quality Manager and Management Related Issues 14
smryan Quality Manual - feedback requested ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Manix Supplier Control and Development Presentation for a Job Interview - Input Requested Supplier Quality Assurance and other Supplier Issues 5
S No Calibration Due Date on a Calibration Certificate unless requested by a customer? Calibration Frequency (Interval) 9
S Customer Complaints - Categorization help requested Customer Complaints 2
P Salary Increment (Opinions Requested) Career and Occupation Discussions 1
L Process Flow Chart for manufacturing of Light Switch requested Process Maps, Process Mapping and Turtle Diagrams 5
P Information on FDA approval for Indian Pharma companies requested Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
W QOS (Quality of Service) Charts examples requested. Quality Tools, Improvement and Analysis 7
Chennaiite Controlled vs. Uncontrolled Document - Clarification requested IATF 16949 - Automotive Quality Systems Standard 11
S Information on Starrett Galileo Vision Measurment System model AV300 requested Calibration and Metrology Software and Hardware 2
X FDA Approval Process - Simple Explanation requested US Food and Drug Administration (FDA) 4
J Charged for an AS9102 FAI Report when requested as part of a Purchase Order? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 23
F First Pass Yield Helped Requested Lean in Manufacturing and Service Industries 1
E Gage R&R - UCLx - Clarification requested Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Sidney Vianna Public Comments Requested on ISO Standard Addressing Six Sigma - ISO 13053 Other ISO and International Standards and European Regulations 9
J Travel guidence requested - JFK - Providence, RI Travel - Hotels, Motels, Planes and Trains 6
R Product (auto parts) manual example requested Quality Tools, Improvement and Analysis 1
W Audit Plan comments requested Internal Auditing 15
M IMDS Submissions for multiple parts requested, but not Design Responsible IATF 16949 - Automotive Quality Systems Standard 13
D Review of Quality Control Plan requested ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Clarification is requested about Corrective & Preventive Action Preventive Action and Continuous Improvement 6
C ISO 9000:2005-Copy requested of Drafts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Visual Work Instructions - Software Recommendations Requested Quality Assurance and Compliance Software Tools and Solutions 19
M QSi Document Control Module and Documentation (examples requested) Document Control Systems, Procedures, Forms and Templates 11
B Constructive criticism of my procedures requested!! Document Control Systems, Procedures, Forms and Templates 5
RoxaneB Clarification Requested on Certificate Wording-Conformance/Certification/Registration Registrars and Notified Bodies 3
I Comments Requested on a Draft Quality Manual Quality Management System (QMS) Manuals 2
I Shutting Down over Requested Price Increase... IATF 16949 - Automotive Quality Systems Standard 5
RoxaneB And the most requested funeral song is... Coffee Break and Water Cooler Discussions 51
K Customer has requested electronic copies of our SOPs and WIs Document Control Systems, Procedures, Forms and Templates 4
W Get MBA? Opinion requested Professional Certifications and Degrees 9
K CQE Exam preparation - Help requested - Planning and Control Techniques Professional Certifications and Degrees 2
Ron Rompen GD&T Advice Requested - Measurement method for a part Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
RoxaneB Sarbanes-Oxley : Details requested on environmental connections Miscellaneous Environmental Standards and EMS Related Discussions 2
M Data submittal for surveillance audit - Detailed list of documents requested IATF 16949 - Automotive Quality Systems Standard 7
RoxaneB Employee/Professional Development and Test Software - Recommendations Requested Quality Assurance and Compliance Software Tools and Solutions 2
L Customer Satisfaction Survey Assistance Requested Quality Tools, Improvement and Analysis 12
Govind Help Requested: Six Sigma Black Belt Certification (CSSBB) Comparison study Professional Certifications and Degrees 16
C PPAP etiquette - Full PPAP Requested for Minor Dimensional Change APQP and PPAP 15
K Review Requested General Auditing Discussions 2

Similar threads

Top Bottom