How to validate hundreds or even thousands of parts?

M

mfgengineer

#1
Hi Forum,

I am well-versed in process validations, ISO13485, 21 CFR 820.75, etc. However, I am still scratching my head when it comes to efficiently/effectively validation a process that involves 1000+ parts.

A practical example may be a machine shop or an injection molding/extruding process. Technically, thousands of parts can be produced from this process (with different parameters and tooling, of course). I was wondering if anyone on this forum has any experience in tackling a situation like this?

The best approach I could come up with is categorize major part 'features' and validate the process that way, but even still, that might take me from validating 1000 'parts' to about '100' which is still unrealistic.

Any advice would be greatly appreciated. Thanks.
 
Elsmar Forum Sponsor

ncwalker

Trusted Information Resource
#2
Take a step back. Don't validate the individual processes, validate the controls - the steps you take to NOT make a bad part.

Those won't be so many.
 
M

mfgengineer

#3
Let me try to clarify the situation:

And I may be inaccurate because I don't work with injection molding, but for simplification:

You have 1 injection molding machine
You have X number of fixturing/templates
You have 1000 different parts that your company manufactures
Obviously for each of the 1000 parts, depending on its design and size, the parameters such as resin mix, temperature, etc all vary.

In a perfect world, you would validate the manufacturing process for each of the 1000 parts. But in a realistic world, that is not cost-effective, nor exactly feasible. Has anyone had to deal with this situation? Any input would be appreciated.
 

Ajit Basrur

Staff member
Admin
#4
Let me try to clarify the situation:

And I may be inaccurate because I don't work with injection molding, but for simplification:

You have 1 injection molding machine
You have X number of fixturing/templates
You have 1000 different parts that your company manufactures
Obviously for each of the 1000 parts, depending on its design and size, the parameters such as resin mix, temperature, etc all vary.

In a perfect world, you would validate the manufacturing process for each of the 1000 parts. But in a realistic world, that is not cost-effective, nor exactly feasible. Has anyone had to deal with this situation? Any input would be appreciated.
Here comes the risk management approach. You can identify the process and product that could encompass the requirements across your product mix, define the validation approach and then execute accordingly.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
I have lots of experience in injection molding and machining etc.

first, these are not "special processes" and so the validation one would do is easier.

Second, each unique part number is in fact validated for most industries. certainly we require it as does such industries as aerospace and defense and medical devices where the parts have critical functions.

the extent of the validation is most certainly risk based and can range from a simple first article to full characterization of the process input space (referred to as "Operating Qualification in the medical device world) and full functional testing in the end system under real world use conditions...

It may seem large to you but suppliers of these parts know this is a requirement (although many don't like it as the validation must typically be approved by the Customer prior to implementation of the process and any subsequent changes) and those who buy these parts are willing to pay for it.

Speaking from my own experience in aerospace, defense and medical device industries, the cost of failures that aren't caught in validation far outweighs the cost of the validation itself.
 

Stoic

Registered
#6
the extent of the validation is most certainly risk based and can range from a simple first article to full characterization of the process input space (referred to as "Operating Qualification in the medical device world) and full functional testing in the end system under real world use conditions...
@Bev D, I'm curious about this interpretation of how risk can determine the extent of process validation, when in the context of FDA regulations. To date, I've not read anything from the FDA, GHTF, or anyone else indicating that any part of IQ/OQ/PQ can be waived based on risk, when it's been determined that the process requires validation. Certainly there are implicit or explicit risk decisions involved in simply identifying the Critical-to-Quality characteristics which are evaluated in OQ and PQ, in determining which products in a given size/configuration matrix need to be tested, and in determination of sample sizes and acceptance criteria. But limiting "validation" to just a first article inspection? Could you please elaborate on scenarios in which this would be appropriate and the logic which supports the approach?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#7
we would have to read the entirety of my post for proper context. even in the portion you quoted I don't say that IQ/OQ/PQ can be 'waived' when it is required by the Customer or when there is a 'special process" or when the final characteristic is a critical characteristic. my response aslo focused on part validation not so much on process validation and it encompassed many industries as the OP was discussing injection molding which can supply many industries.
So called special processes must always be validated even in most non-FDA industries.
Ditto fro

There are some component parts that are engineered and fully characterized for how they effect a product. in the original design these are of course validated per IQ/OQ/PQ type of studies - we must validate that the characterization is correct. However for these parts when a change occurs it is often sufficient to simply perform a first article inspection (for parts across the input tolerance range - which some my refer to as OQ at least from the suppliers perspective) since if the changed part meets the drawing requirements we know it will function correctly. This is common in aerospace and automotive but not as common for medical devices. The key here is that the design space - which is multi-layered - is engineered, well characterized and validated in the original design. It also will depend on the severity of the effect of a failure of the part in the final system. If the effect of failure is trivial (again well known and validated in the original design - not just a guess), there is little need for more than a first article inspection.

Hope this helps?
 
Thread starter Similar threads Forum Replies Date
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T How to “validate/qualify” a new measurement equipment? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
kisxena Memo to File - Failure to Validate Supply Chain Security Management Systems 1
A ISO 13485:2016 - Validate our use of software that impacts on the QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
A Process to Validate the Accuracy of Test Reports (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 38
C Do we need to Validate Off the Shelf Software? Manufacturing and Related Processes 5
B How to validate Microsoft Excel Spreadsheet Calculations for the Cpk value Capability, Accuracy and Stability - Processes, Machines, etc. 9
M How to validate a system to make it compliant with 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 2
B Do I need to validate my database software? Calibration and Metrology Software and Hardware 1
K COTS Validation: Should we validate Windows after each Update? IEC 62304 - Medical Device Software Life Cycle Processes 3
S How to validate a homegrown software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A How to verify and validate the effectiveness of CAPA with regards to employees ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A When to verify and when to validate Design Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H How To Validate Electronic Part From Non Authorized Distributor Process Maps, Process Mapping and Turtle Diagrams 7
G Prototype Manufacturing Equipment - Validate or not to validate? Quality Manager and Management Related Issues 2
SteveK How to validate Device Shelf Life? CE Marking (Conformité Européene) / CB Scheme 8
M Destructive VTMV Subgroups - A Destructive Variable Test Method to Validate Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
M How to validate a Dye Test method used to evaluate Package Integrity Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
I When to Validate and when not to Validate US Food and Drug Administration (FDA) 24
C How do you Validate Solderability of Components Prior to Soldering Operations Manufacturing and Related Processes 5
M Welding - to Validate or Not? If so, How? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V Do we need to Validate a Server/Back-End System? Qualification and Validation (including 21 CFR Part 11) 2
I Using validated SAS JMP to validate Excel for Statistical Analysis? Qualification and Validation (including 21 CFR Part 11) 11
E How to Validate Master Equipment that has been brought to onsite General Measurement Device and Calibration Topics 12
E When to Validate a Process - 21 CFR Part 820.75.(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R How to bond PVC (Tygon) Tubing and Validate the Process ISO 13485:2016 - Medical Device Quality Management Systems 13
T Do I need to validate a basic Excel spreadsheet Quality Assurance and Compliance Software Tools and Solutions 10
R Process Validation - Adhesive Bonding, what to validate and how? Qualification and Validation (including 21 CFR Part 11) 10
N How to Validate a Gage R&R Spread Sheet General Measurement Device and Calibration Topics 3
A How to Validate Effectiveness of Mitigations? ISO 14971 - Medical Device Risk Management 13
C Validate the idea of a Composite Performance Index Quality Tools, Improvement and Analysis 4
M How to determine/validate the "REQUIRED MANPOWER" in an office environment? Service Industry Specific Topics 4
R How to Validate Vision Inspection Systems Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Third-party lab needed to validate cleaning & disinfection? EU Medical Device Regulations 12
Proud Liberal How to validate the geometry of a 8 mm pitch, 22 tooth Gates HTD sprocket Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T How does a tool-shop validate molds? Verification vs. Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Validate 99.5% reliability 90% confidence - Sample size calculation Reliability Analysis - Predictions, Testing and Standards 4
J Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations ISO 13485:2016 - Medical Device Quality Management Systems 3
N Periodically validate test reports for raw material - AS9100 7.4.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
V Calibration of a Digital Vernier - Need to check/calibrate/validate all 3 functions? General Measurement Device and Calibration Topics 9
P Last-off-part comparison used to validate the set-up (TS16949 Clause 7.5.1.3) IATF 16949 - Automotive Quality Systems Standard 3
E How to validate product if gage is determined out of calibration Document Control Systems, Procedures, Forms and Templates 19
M Digital Filling System - What do I need to Validate Here? Software Quality Assurance 1
M Seat Cover Product Validation for PPAP - How can I validate my product? APQP and PPAP 12
N Do we need to Validate Outsouced Processes? ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
E GMW3172 - Thermal Shock and PTC cycles required to validate an electronic system Reliability Analysis - Predictions, Testing and Standards 2
A Software Observation during ISO 9001 Audit - Validate and Re-validate Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12

Similar threads

Top Bottom