SBS - The best value in QMS software

100% Sort Verification - Statistical Method for Evaluating Suspect Material

G

Gary E MacLean

#1
Good morning all;

I would like to request some assistance.

We bottle fruit into glass jars with metal closures. They rapidly flow down the filling line at the rate of about 15,000 jars per hour. We have an in-line metal detector that scans every jar prior to having the metal cap put on. We verify the detector with known rejects once every one hour.

Typically we can expect about 5 legitimate rejects per month or about 5 jars every 2.5 million jars. On occassion the metal detector vibrates out of setting. We can fix that, that is not the problem. But, when we go to check our known rejects they fail. By the time we check we have produced 15,000 jars with closed lids and vacuum established.

We segregate all materials then try to figure out what to do. Our FMEA, or scheduled process, says we must rerun all product. That is we must open every jar, tossd the lid, dump the fruit into a hopper for refill and either wash or trash the jars.

What I am hoping is that there is a statistical method for evaluating, sampling the suspect material to make a viable risk analysis and resultant decision that may save the rework and material loss costs.

Can anyone help?

Rate = 15,000 / hour
Fail = 5 / 2,500,000
Check = 100%

Thank you

Gary E MacLean
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Good morning all;

I would like to request some assistance.

We bottle fruit into glass jars with metal closures. They rapidly flow down the filling line at the rate of about 15,000 jars per hour. We have an in-line metal detector that scans every jar prior to having the metal cap put on. We verify the detector with known rejects once every one hour.

Typically we can expect about 5 legitimate rejects per month or about 5 jars every 2.5 million jars. On occassion the metal detector vibrates out of setting. We can fix that, that is not the problem. But, when we go to check our known rejects they fail. By the time we check we have produced 15,000 jars with closed lids and vacuum established.

We segregate all materials then try to figure out what to do. Our FMEA, or scheduled process, says we must rerun all product. That is we must open every jar, tossd the lid, dump the fruit into a hopper for refill and either wash or trash the jars.

What I am hoping is that there is a statistical method for evaluating, sampling the suspect material to make a viable risk analysis and resultant decision that may save the rework and material loss costs.

Can anyone help?

Rate = 15,000 / hour
Fail = 5 / 2,500,000
Check = 100%

Thank you

Gary E MacLean

Hi Gary,

I'm not quite understanding the process. You say that the metal detector checks the jars before the lid is put on. Does this mean that the purpose of the metal detector is to find metal in the product itself? You also say, "... when we go to check our known rejects they fail." Do you mean that the "known rejects" are false positives (no metal present), or that you verify that there is indeed a failure involved?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Good clarifying questions from Jim as always. However, if you are really looking for metal in the jars and you are targeting for NO metal in the jars (I hope) then my recommendation would be to continue to do as you have done. refill and retest. the failure rate is far too low requires 100% testing anyway for almost any 'lot' size.
 
G

Gary E MacLean

#4
Hi Jim

Thanks for the rapid response

The process is;
Empty jars are loaded onto line
Empty jars are inverted and washed on line
Empty jars are turned upright and passed through a product filler
Product is put into jars
Jars with product then continue to a liquid fill station
Liquid is put into jars
Jars are passed through a wrap around metal detector
Purpose of detector is to find any foriegn / vagrant metal inside jars
Checked jar with product and liquid inside is passed through capper
Jar is evacuated of gasses and capper applied
Vacuum is formed inside jar

Once an hour jars with product, syrup and known test metal inside are passed through detector
Purpose of this activity is to verify the detector is still sensing metal

So, yes, the purpose of the metal detector is to find metal in the product.
The known rejects are product jars with metal present - the detector should be able to see them.

My problem is that on one of these hourly checks our detector failed to see the test metal in the product jars. It was discovered the detector had been inadvertently adjusted to an improper sensitivity. Now we have 15,000 jars of product that were accepted by the metal detector but we do not know if the detector was really working or not.

We typically have 5 to 6 legitimate metal discoveries for every 2.5 million jars. I would like to know if I can somehow statistically justify either not rejecting these jars of product or sampling a statistically valid number of jars to show that metal is really not present. There, of course, is not supposed to be any metal whatsoever in our product.

Thanks for your help.

Gary E MacLean
 
G

Gary E MacLean

#5
To Bev D

Hi Bev

Yes, we are really looking for metal in the jars. And, yes we are trargeting for NO metal in the jars. I am also looking for some sort ofr risk analysis and / or cost justification. To refill and retest requires us to soak all labels off because the jars have to go through the washer again. Then we dump all product to start back over and we also lose all metal caps. Once they have been applied they are not acceptable for new product use.

The existing failure rate is 5 / 2.5 million. I don't even know the PPM for that but it seems as though we could sample a statistically valid number of jars and make our decision from that sampling.

Can this work?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
To Bev D

Hi Bev

Yes, we are really looking for metal in the jars. And, yes we are trargeting for NO metal in the jars. I am also looking for some sort ofr risk analysis and / or cost justification. To refill and retest requires us to soak all labels off because the jars have to go through the washer again. Then we dump all product to start back over and we also lose all metal caps. Once they have been applied they are not acceptable for new product use.

The existing failure rate is 5 / 2.5 million. I don't even know the PPM for that but it seems as though we could sample a statistically valid number of jars and make our decision from that sampling.

Can this work?

nope. statistics wont' help you. at a 5 in 2.5 million failure rate your ppm = 2 or 0.000002. using the Poisson distribution and a confidence level of only 99% your sample size is: 2,302,586
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#7
my larger view suggestion is that you develop a process for verifying the effectiveness of your tester after any changes with you known bad units prior to making sellabel product. you will pay a lot for this lesson, it would be a shame to not learn something from it.
 

Jim Wynne

Staff member
Admin
#8
my larger view suggestion is that you develop a process for verifying the effectiveness of your tester after any changes with you known bad units prior to making sellabel product. you will pay a lot for this lesson, it would be a shame to not learn something from it.
Good advice; you might also want to consider sending in the control jars at a frequency more often than once an hour, which would reduce the amount of sorting necessary if the metal detector fails for any reason.
 
G

Gary E MacLean

#9
Well Bev

I only have 15,000 at risk jars; there were only 15,000 jars that got checked through the questionable metal detector. My 2.5 million number is how many it takes to create 5 bad ones.

Does that change your prognosis at allo?

Gary E MacLean
 
S

somerqc

#10
As Bev is using the 2.5 million number to determine PPM, I doubt the numbers would change.

I think what everyone is telling you is that you are better off to empty everything and refill the 15,000 jars than to risk a recall and the associated costs.

I am assuming you are registered to some kind of quality system. Most systems outline having control of any calibrated equipment. It strikes me that you may not have the necessary controls required to ensure that the machine maintains the necessary calibration status. Just my :2cents: You may want to investigate how the machine "suddenly" does "see" metal anymore.

John
 
Thread starter Similar threads Forum Replies Date
L Verification of 100% Sort QS-9000 - American Automotive Manufacturers Standard 11
V Supplier Capability and 100% Sort causing Gage Wear APQP and PPAP 1
V PPAP - Requirements when Cpk is <1.67 - 100% Sort for Defectives APQP and PPAP 8
D Looking for 100% sort testing equipment for overall length, flatness, and parallelism General Measurement Device and Calibration Topics 1
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
A What to do when 100 % verification is not 100 % Manufacturing and Related Processes 5
Nicole Desouza ISO / AS Certification - Small business with less than 100 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M EU – Chemical Safety Report – CSR – REACH Authorisation decisions – Triton X-100 – Ortho-clinical-Use1 REACH and RoHS Conversations 0
D Measuring fine tubing (< 0.100") "Wall by weight" General Measurement Device and Calibration Topics 11
Marc Anniversary of the First Trans-Atlantic Flight 100 years ago - June 2019 Coffee Break and Water Cooler Discussions 2
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
BHobbs_Busche All Measurements taken with a Variable Gage have to be Recorded 100% IATF 16949 - Automotive Quality Systems Standard 14
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
S 100% Final Inspection Requirements of Active Medical Devices (MDD or IEC Standards?) EU Medical Device Regulations 4
B Is Gage R&R required on a 100% Dimensional Layout? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
K IEC 61010-2-100 Labeling question - IVD equipment Other ISO and International Standards and European Regulations 1
D Long length measurement of 18" up to 100" with an accuracy of .005 min General Measurement Device and Calibration Topics 8
F Yield reaction higher than 100% Manufacturing and Related Processes 3
S Suggestions for a 100% Paperless Manufacturing Shop Floor Quality Tools, Improvement and Analysis 10
M Can OEE (overall equipment effectiveness) exceed 100%? Manufacturing and Related Processes 2
G Sampling Question - Random Sample of 100 pcs and 11 pcs. have been rejected Inspection, Prints (Drawings), Testing, Sampling and Related Topics 30
Marc 100 Years of Change in the United States - 1913 - 2013 Coffee Break and Water Cooler Discussions 5
E Is there a specific regulatory requirement for 100% inspection of IFUs? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
N Switch to 100% inspection when lot fails sampling? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
K 100 years war aviation - A plane is used for bombing World News 3
S ATA (Aerospace Testing Alliance) Specifications 100, 200 and 300 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K SPC to apply for Particle in Clean Room Class 100 Statistical Analysis Tools, Techniques and SPC 7
N What Makes Life 100% (joke) Funny Stuff - Jokes and Humour 0
P Sample Size to Test Products used for 100 hours in a Test Environment Reliability Analysis - Predictions, Testing and Standards 2
R Problems with Supplier - Always with 100% Sorting - No Corrective Actions Supplier Quality Assurance and other Supplier Issues 22
R Why do outgoing QA Sample Testing again when Product is tested 100% Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Ajit Basrur China to launch 100 rockets, 100 satellites by 2015 Coffee Break and Water Cooler Discussions 1
G Is Controlled Shipping requirement Sampling Based or 100% Inspection? Misc. Quality Assurance and Business Systems Related Topics 3
J MSA Emergency - PV%=100(PV/TOL)in American? And that is correct? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
C What to expect in a GE Aerospace Audit of a 100 Person Machine Shop Customer and Company Specific Requirements 5
R Research involving a very small population (100 approx) - Help with Sampling Statistical Analysis Tools, Techniques and SPC 3
N 100% Inspection in Retail Warehouse which Ships Products to Customers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
P FDA Part 820 Clause 820.100 Corrective and Preventive Action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Can a Major Nonconformance be Open but 100% Resolved? IATF 16949 - Automotive Quality Systems Standard 6
K 100% Inspection or do the usual IQ, OQ, PQ Validation - Medical Molding Design and Development of Products and Processes 3
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
S 100 Places to Remember Before They Disappear Coffee Break and Water Cooler Discussions 8
J Functional Test Sampling - Determining Sample Size to eliminate 100% Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Taking samples in a 100 cavity mold for Xbar-R chart Statistical Analysis Tools, Techniques and SPC 1
Stijloor 100 Best companies to work for. Career and Occupation Discussions 0
A Elsmar's Social Group "Mexican Curious" reached 100 Members Coffee Break and Water Cooler Discussions 8
J What Control Chart should be used for Microbial Limit (NMT 100 cfu/m3) Statistical Analysis Tools, Techniques and SPC 12

Similar threads

Top Bottom