What to do if parameters are found to be Outside of Control Limits

T

Tmannkzoo

Hi,

I am looking for a procedure that would clearly define what to do if parameters are found to be out of control limits.

For example if during a baking process the oven were to ramp up above the spec limit for a period of time.


Any input or sample procedures would be of great help!!:thanx:
 

Bev D

Heretical Statistician
Leader
Super Moderator
I am going to assume that you mean specification limits and not (statistical) control limits. in general, specification limits are intended to distinguish between conditions that will create acceptable product and unacceptable product.

so if the thermal cycle goes beyond the temperature specifications we assume that some adverse consequence has occurred to the parts. we either scrap the parts or rework them - if possible. depending on your industry you may require Customer testing and/or approval prior to rework (or repair).

Of course your specification limits may be simply guidelines or may not have been engineered/validated and so you may have no idea what the adverse consequences may be - if any. this would require expert opinion to assess the potential failures/damage and testing to confirm whether or not the parts were harmed. the result may indicate that the parts be scrapped or reworked or used as is. again you may need customer testing and/or approval - or at least notification - of any rework or use-as-is disposition.
 
T

Tmannkzoo

Thanks for the input and Yes you are correct! Specification limits.
 
P

PaulJSmith

In addition to Bev's excellent advice regarding the product, you'll want to investigate why your process and/or equipment is not adhering to the set limits.

Knowing the effects on the product will help you determine how to handle that. Knowing WHY it happened will help you in preventing its recurrence.
 
T

Tmannkzoo

THANKS! The issue is that I received an observation with correction for this during my recent Audit. The problem being, the process PFMEA is held by the customer. We simply complete a varnish process and bake the parts in a chamber oven that is both validated and calibrated.

My finding reads "are procedures established that would clearly define what to do if parameters are found to be out of control limits"

Since my customer holds the PFMEA I would simply record the findings and return the part to them to make the determination.

I was just curious if anyone may have a similar "generic" procedure that would cover this, with out having to change a current procedure or write up a new one.


Thanks for all your help!!
 

Bev D

Heretical Statistician
Leader
Super Moderator
OK - now I understand your situation. your approach is completely sound

That exact instruction can be documented in a SOP to cover all future occurrences OR you could include a standard 'instruction' on the specific lot work order/traveler or whatever you use to provide specific instructions for each job that has this condition. I've seen both used successfully.
 
Thread starter Similar threads Forum Replies Date
V PQ parameters for computer system validation of configurable software of laboratory equipment Qualification and Validation (including 21 CFR Part 11) 0
L Cpk in relation to individual process parameters. Reliability Analysis - Predictions, Testing and Standards 1
E Comparing process parameters on non-normal batches Capability, Accuracy and Stability - Processes, Machines, etc. 11
M Stability with min/max sealing parameters? Other Medical Device Related Standards 1
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B WEDM Taguchi and Anova Analysis - L16 array with 5 parameters at 4 levels Manufacturing and Related Processes 15
I Quality of Potable Water Testing Parameters during Purified Water Validation Qualification and Validation (including 21 CFR Part 11) 1
E IEC 60601-2-57 item 201.12.4.2 - Indication of parameters relevant to safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
N Regression Model (Minitab 18) - Which values my input parameters should have Using Minitab Software 2
M AS9100 D 8.3.4.1 a - Parameters to be recorded" - What is this asking for? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Insights on Transactional Ticket Audits such Parameters, Weighting Points, etc ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N ISO 11135 Monitoring Routine ETO Sterilisation Parameters Other Medical Device Related Standards 3
V Process Capability for parameters with non-normal distribution. Capability, Accuracy and Stability - Processes, Machines, etc. 16
D minitab macro to pull access query with parameters Using Minitab Software 1
Roberticus MSA for gaging which specifies process parameters and 7.6.1 Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
L How do you specify your receiving inspection parameters? Misc. Quality Assurance and Business Systems Related Topics 2
S Testing software-only device on hardware - What are the hardware parameters? Software Quality Assurance 6
0 Visualizing ranges of 3 parameters with 6 variables Quality Tools, Improvement and Analysis 5
M New Calibration Laboratory Set Up Measurement Parameters and Equipment General Measurement Device and Calibration Topics 4
P MSA requirements for Systems that Measure Process Parameters Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
P Problem with the Classification of the Process Parameters IATF 16949 - Automotive Quality Systems Standard 6
K Data Analysis of Milk Composition (Seven Parameters like Protein, Fat, Lactose, etc.) Using Minitab Software 18
R Which parameters to be addressed in Control Plan from FMEA? FMEA and Control Plans 2
R How to assess capability for parameters which has got either Min values or Max values Statistical Analysis Tools, Techniques and SPC 2
M The General Parameters of IQ, OQ & PQ - Depyrogenation Tunnels and Autoclaves General Measurement Device and Calibration Topics 2
A Comparing Effect of Process Parameters on Equipment Performance during Start Ups Statistical Analysis Tools, Techniques and SPC 3
A SPC for Metal Foundry Parameters like Metal Temperature, Sand Moisture Statistical Analysis Tools, Techniques and SPC 5
N Different Distribution Parameters when analyzing the same data in different ways Using Minitab Software 8
R Analysis of Welding Parameters - Can Taguchi methods provide equation? Using Minitab Software 11
V The approach/criteria of setting Acceptance Limits Method Validation Parameters Statistical Analysis Tools, Techniques and SPC 1
P General Parameters to Approve Supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Hoffman Scratch Hardness Test - General Parameters for Pass/Fail (Paint Coatings) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q TS 16949 Process Capability Requirements - Cpk ≥ 1.67 on All Key Parameters? IATF 16949 - Automotive Quality Systems Standard 8
J Critical Process Parameters vs. Critical Performance Parameters - Definitions Qualification and Validation (including 21 CFR Part 11) 2
O Correlation of 2 Test Devices - 2 samples (13 parameters) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Problems with DOE - Different levels in parameters of a full factorial experiment Using Minitab Software 1
M True Position of a Hole Capabilty - Appropriate parameters to use Capability, Accuracy and Stability - Processes, Machines, etc. 5
Q Equipment Parameters in Control Plan? IATF 16949 - Automotive Quality Systems Standard 4
V Process Parameters in Textile Lamination Manufacturing and Related Processes 2
D Subjective parameters and Quality costs - VDA 16 IATF 16949 - Automotive Quality Systems Standard 6
T Process Specifications and Control Parameters Document Control Systems, Procedures, Forms and Templates 4
W Surface Finish parameters - Mechanical stylus based testing of a cylindrical part Manufacturing and Related Processes 2
D How should "Set-up" Parameters be Addressed in Control Plans? FMEA and Control Plans 1
U Minitab Distribution Fitting 3 Parameters? Using Minitab Software 1
J Run Charts and Alternative Process Control Parameters Statistical Analysis Tools, Techniques and SPC 5
A Information About Benchmarking Parameters of Castings Used for Automobile Sector Benchmarking 2
A Is zero defects possible? We are dealing with 25 to 30 parameters Quality Tools, Improvement and Analysis 21
D Is the Equipment for Measuring Process Parameters covered by ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom