Sampling Evidence requirements - Pursuing AS9100

L

lego55

#1
Hello-

I am new to the manufacturing field and have never had to work with sampling and inspection before. However, I am not new to the quality field. We are ISO 9001:2000 and pursuing AS9100. We are also audited by a company that would like us to be ISO 13485 compliant.

My question: For all the samples the Inspectors measure, do they need to show evidence of their sampling? For instance, if they have 100 items as a sample size, do they have to do 100 Final Inspections and show all measurements? The inspectors have never shown evidence of their sampling before. They will be very resistant! We now follow a C=0 plan with AQLs related to part or company.

Please let me know if you need more information. As a newbie, this particular question is weighing heavily on me. :frust:

Thank you, in advance, for your answers!
 
Elsmar Forum Sponsor
A

Audit Monkey

#2
Re: Sampling evidence

When I audit, I will ask for evidence that the sampling plan has been followed. For example, if the sampling plan calls for 5 samples at particular times of the day, well, show me that it was done.

I also look for someone to understand the 3 components of sampling: size of the sample, frequency of sampling and type of sample (consecutive, random, etc). I ask this because I want to know if someone there understands the effect of sampling on the statistics involved.

From the inspectors, I want to know if they know the sampling plan and are following it. If the sampling plan is written down somewhere, that just makes it easier, but in ISO9001 it is not required to be written down (although there may be a corporate or customer requirement for this). If the process is complex or involves many inspectors, I will ask several inspectors what the sampling plan is. If they all give me the same answer, there is no NC. If their answers vary, there is an NC.
 
A

Audit Monkey

#3
Re: Sampling evidence

Your post:
My question: For all the samples the Inspectors measure, do they need to show evidence of their sampling? For instance, if they have 100 items as a sample size, do they have to do 100 Final Inspections and show all measurements? The inspectors have never shown evidence of their sampling before. They will be very resistant! We now follow a C=0 plan with AQLs related to part or company.

I do not quite understand the situation. It sounds like they're taking measurements, determining that the product passes, and not recording anything other than perhaps a pass-fail.

Are they measuring all parts? I assume not. So I assume they are measuring a sample. So what kind of sample? Once a hour? 100 sequential parts? Whenever they feel like it?

The sampling plan can affect the outcome of your statistical analysis. As an auditor, I check sampling plans (for conformance) when I audit the process surrounding manufacturing of course, but also during the audit of data analysis and use of data in process monitoring.

Conformance to sampling plan: If the plan calls for 100 pieces, is that done? This can be many things, not necessarily a list of the 100 pieces. it can be a signature, for example.
 
L

lego55

#4
Re: Sampling evidence

Your post:
My question: For all the samples the Inspectors measure, do they need to show evidence of their sampling? For instance, if they have 100 items as a sample size, do they have to do 100 Final Inspections and show all measurements? The inspectors have never shown evidence of their sampling before. They will be very resistant! We now follow a C=0 plan with AQLs related to part or company.

I do not quite understand the situation. It sounds like they're taking measurements, determining that the product passes, and not recording anything other than perhaps a pass-fail.

Are they measuring all parts? I assume not. So I assume they are measuring a sample. So what kind of sample? Once a hour? 100 sequential parts? Whenever they feel like it?

The sampling plan can affect the outcome of your statistical analysis. As an auditor, I check sampling plans (for conformance) when I audit the process surrounding manufacturing of course, but also during the audit of data analysis and use of data in process monitoring.

Conformance to sampling plan: If the plan calls for 100 pieces, is that done? This can be many things, not necessarily a list of the 100 pieces. it can be a signature, for example.
AuditMonkey-

Thank you for both answers!

The sampling plan is written and visible in the Inspection Room. The Inspectors sample throughout the day and put their signature on the required line each time they visit. They were just recording it as PASS or FAIL, but I want them to record actual measurements. SPC is not in use yet--we are a very small shop. They randomly sample until the last part, which is for final inspection. Also, they seem to be checking different dimensions, not all, with each part they sample.

Going back to the 100 as a sample, are they required to 100% measure all dimensions for each sample part instead of some? If so, wouldn't they have to write down all dimensional measurements for evidence?:confused:
 
A

Audit Monkey

#6
Re: Sampling evidence

Also, they seem to be checking different dimensions, not all, with each part they sample.

What dimensions are required is usually defined by the organization rather than being left to the inspector. I find it odd that they apparently decide for themselves what to measure and what not to measure. I would very probably give you a NC if I audited you - for non-robust effectiveness of the sampling plan.

Going back to the 100 as a sample, are they required to 100% measure all dimensions for each sample part instead of some? If so, wouldn't they have to write down all dimensional measurements for evidence?

There are 2 questions here.
1. What needs to be written down. If your internal procedures do not require the actual dimensions to be written down nor do your customer requirements, the pass-fail notation would be acceptable, although I strongly question the effectiveness of the choice. That seems on the surface to go back to the old goal-post mentality of SPC. (If it meets the spec, it is ok.)

2. I have rarely seen a part where all dimensions need to be checked. Usually the organization determines which dimensions are critical to control and has those measured. If you are going to implement SPC, you would need to determine those critical measurements required and yes, have those written down. Yes, I will audit to be sure they are written down. And yes, I do audit those measurements including checking the math :).

Then of course, you need to decide which statistical method to apply. You have variables so the usual suspects would be Shewhart charts or one of that family.
 
G

Gordon Clarke

#7
Re: Sampling evidence

Hello-

I am new to the manufacturing field and have never had to work with sampling and inspection before. However, I am not new to the quality field. We are ISO 9001:2000 and pursuing AS9100. We are also audited by a company that would like us to be ISO 13485 compliant.

My question: For all the samples the Inspectors measure, do they need to show evidence of their sampling? For instance, if they have 100 items as a sample size, do they have to do 100 Final Inspections and show all measurements? The inspectors have never shown evidence of their sampling before. They will be very resistant! We now follow a C=0 plan with AQLs related to part or company.

Please let me know if you need more information. As a newbie, this particular question is weighing heavily on me. :frust:

Thank you, in advance, for your answers!
I thought sampling plans based on things like AQL values went out with the dodo (extinct) but perhaps not in the USA.? I honestly can't remember the last time I heard someone in Europe referring to AQL values. The fact that defects are "allowed" seems to go against everything I fight for. Of course mistakes are inevitable but NEVER should they be permissable. I'll bet no Japanese company or product would base their name and reputation on "allowing" defects.

To simplify (and at the same time complicate) matters a component with 20 dimensions could be out of tolerance on two relatively uncritical dimensions. The simple, logical thing to do is to note the deviation(s) and document it. The action to be taken can then be determined but at least then the error is documented. A deviation on a critical dimension would of course require more effort and action.
 
A

Audit Monkey

#8
Re: Sampling evidence

AQL is so old-fashioned that this is the first I have seen it or heard it some time. Even in the US :D

This might be more common in very small shops which have not had a well trained QM.
 
G

Gordon Clarke

#9
Re: Sampling evidence

AQL is so old-fashioned that this is the first I have seen it or heard it some time. Even in the US :D

This might be more common in very small shops which have not had a well trained QM.
Whew :D my faith in the good old US of A has just been restored :applause:

If a manufacturer can't produce without defects then they should make the neccessary extra number and apply 100% inspection. That might make these suppliers wake up instead og forcing the "customer" to do an incoming inspection.

A company that needs an incoming inspection invariably has sub-standard suppliers. How about incoming inspection being placed directly under the purchasing dept.? That might make the buyer think more about total costs!

I know of one company that normally supplied their suppliers with measuring equipment (gauges etc.). At a meeting the suppliers were informed that this practice would stop as it involved many extra costs including calibration. One of the suppliers immediately stated that this would raise the price on their products. The prompt reply was, "Good, as we'll then finally know the real price for our deliveries".

I often wonder why I'm not Mr. Popular with all suppliers :notme:
 
L

lego55

#10
Gordon and AuditMonkey,

Does that mean you would use SPC and 100% inspect all parts...no sampling?

Please elaborate about the alternatives and the way you would approach it. As many details as possible will really help me. :confused:

Thank you!
 
Thread starter Similar threads Forum Replies Date
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C Sampling - ISO 16269-6 vs ISO 2859 Other ISO and International Standards and European Regulations 0
L Sampling Plan Risks AQL - Acceptable Quality Level 6
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M Minitab Capability of the Population (no sampling) Using Minitab Software 11
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
R Reduced sampling plan for sterial products APQP and PPAP 0
A ISO 2859-1 - 9.3.3.2 Switching score - Sampling Plans and PPM AQL - Acceptable Quality Level 0
R BS EN 12060:1998 - Zinc and zinc alloys Method of sampling Specifications Manufacturing and Related Processes 4
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
8 Activity Sampling Exercise Lean in Manufacturing and Service Industries 11
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
Nicole Desouza Sampling plan for a customer who wants AQL 1.0 (per ANSI Z1.4) AQL - Acceptable Quality Level 5
V How to interpret AQL sampling tables AQL - Acceptable Quality Level 5
A AQL sampling bags of parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C Applying Weibayes to Attribute sampling Reliability Analysis - Predictions, Testing and Standards 0
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
E Sampling for capability studies for variables and attributes Capability, Accuracy and Stability - Processes, Machines, etc. 4
O Statistical justification of sampling size in V&V tests ISO 13485:2016 - Medical Device Quality Management Systems 5
M Sampling Plan for Alumin High Pressure Die Castings Manufacturing and Related Processes 0
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Inspection/sampling economics Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S How to make a Sampling Plan - Conveyor belts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
J AQL for Effectiveness Check - What AQL tiers to use on this type of sampling? Nonconformance and Corrective Action 9
N The question asks about sampling plans and AQL Reliability Analysis - Predictions, Testing and Standards 5
S Help develop sampling plan for prototype samples (medical devices) Statistical Analysis Tools, Techniques and SPC 7
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
C Are zero defect sampling plans relevant to AS9120B Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R DCMA Sampling of CSI Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Zero Defect Sampling Plan Standards Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
L ISO 2859-2 LQL sampling plan linked to %confidence/%reliability Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Sampling Plan for transparent tubular plastic parts from 32 different cavities Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M ISO / ASTM standards for Sampling Plans for Medical Devices Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
N Sampling for stability studies - Class II surgically invasive devices Other Medical Device and Orthopedic Related Topics 1
S Surveillance Sampling Test - Determining Sample Size Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A AQL Sampling Plan SOP / WI - Medical Device Industry Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
B IATF 16949 Cl. 8.6.6 - Acceptance Criteria - Zero Defects Attribute Data Sampling IATF 16949 - Automotive Quality Systems Standard 2
C Sampling of Class IIb Implantables under EU MDR - Assessments to the EU MDR EU Medical Device Regulations 4
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2

Similar threads

Top Bottom