Month: July 2018

Nonconformance Disposition

Chart, graph, sampling, plan, calculation, z1.4

Question

Should the person writing a non-conformance also be the person who dispositions the same non-conformance?

Answers

From John Surak:

This question is interesting.  In addition, there may be a lack of information to properly answer the question.  There is nothing in ISO 9001:2015 that prohibits the person who wrote the non-conformance from ensuring that non-conformance is addressed in an effective manner.  However, several questions remain.  Why did an individual write a non-conformance on one’s self?  Why did the person just take actions to eliminate the non-conformance without having to implement a correction or corrective action process?  This issue would be an interesting discussion during an audit, and it may lead to an audit trail that discusses leadership and commitment.

John G. Surak, PhD

From George Hummel:

This answer depends upon how you define “dispositions.”  If you mean take the corrective action, then no.  If you mean determines the effectiveness and evaluates the results, then yes.

For more on this topic, please visit ASQ’s website.

ISO 9001: 2015 Clause 8.3.4 and Product Design

PLCs, programmable logic controllers

Question

My company is implementing ISO 9001:2015 and my question is regarding Clause 8.3.4 d. Our company designs product for only 20% of our customer base. We do not have a validation process. We do send a prototype to the customer to test the part for a period of time to approve the design. In determining the scope of our organization, can we exclude the validation process and still become ISO 9001:2015 certified?

Answers

From John Surak:

This organization is involved in product design.  Therefore, the product design cannot be excluded.  However, the organization needs to review the validation clause.  8.3.4d states the following:   “validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.”  It should be noted that neither 8.4.3d not the validation refences in ISO 9001 do not prescribe a method on how to conduct validation.  It would appear that the company has some sort of process they use to develop the prototypes.  This process should be codified or documented so that it is done in a consistent manner and in a way to ensure that the customer needs are met.

John G. Surak, PhD

From George Hummel:

Basically, you are outsourcing validation.  Therefore, you need to control that process per 8.4. I would not accept the exclusion. In the future, you may have a customer that requires you to do the validation. However, the final answer would be provided by your certification body.

Click here for more resources about ISO 9001: 2015.

Z 1.4 Inspection Levels

Pharmaceutical sampling

Question

I am using a reduced switching rule and I don’t understand the meaning of the numbers in the first box. Total noncomforming less than limit number? What’s my limit number?Does production stability mean capability? Would I use 1.33?  The table has an arrow to reduced, so would I move to the next box?

Answer

The ANSI/ASQ Z1.4 standard has three inspection levels: normal, reduced and tightened inspection.  Initially you start at normal inspection, and can move to either tightened or reduced inspection depending on how lots are dispositioned.  Based on Figure 1 of the standard, the determination to move amongst the levels can be ascertained.  When you get to the reduced inspection level (Table II-C), you need to read the footnote (†).  It states “If the acceptance number has been exceeded, but the rejection number has not been reached, accept the lot, but reinstate normal inspection.”

A stable process or production is less about a capability index, and more about the control chart of the data showing a stable process.  In other words, the process is stable over time.

Steven Walfish

For more information about this topic, please visit ASQ’s website.

Confidence Levels

Data review, data analysis, data migration

Question

I would like to confirm if ASQ Z1.4-2008 attribute tables are calculated based on 95% confidence level? I am using Table II-A, on page 11.

Answer

ANSI/ASQ Z1.4 tables are not technically calculated based on a 95% confidence level.  The technical definition of AQL is the quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling.  Some interpret it to mean if a lot has AQL percent defective or less, a lot would have a high probability of being accepted based on the sampling plan.  The standard does not specify the probability of acceptance explicitly.  The operating characteristic curve (OC Curve and the tables define the AQL as the percent defective that has a 95% probability of acceptance.  So though it is not a 95% confidence level, it is a 95% probability of acceptance.

Steven Walfish

For more information on this topic, please visit ASQ’s website.

Zero Acceptance Number Sampling Plans

Airplane, aerospace, AS9100

Question

Regarding Nicholas Squeglia’s Zero Acceptance Number Sampling Plans, in the 4th edition for lot size 151-280 (1% AQL), a sample size of 20 is provided.  However, in the 5th edition, for the same lot size 151-280 and AQL of 1%, the sample size is 29. Which is correct – a sample size of 20 or 29?

Answer

In the 5th edition of Nicolas Squeglia’s book, he mentions on page xii the rationale of the change in sample sizes.  From  the 5th edition, “in the early 2000’s, a large aerospace manufacturer was given permission by ASQ to reproduce the c=0 sampling table.  They modified the table by changing several sample sizes, and for convenience it was therefore originally decided to carry those modifications into the fifth edition.”

Table 1a is the original tables (4th edition and previous) which has the sample size of 29.  Use this table unless otherwise specified by contract.

Table 1b is the modified table which has a sample size of 20.

Thanks

Steven Walfish

For more on this topic, please visit ASQ’s website.

Calibration Questions

Automotive inspection, TS 16949, IATF 16949

Question

I work at a hydraulic cylinder manufacturer. The company has homemade thread and ring gages in house that we are using for production that are not sent out for calibration but have a homemade master that is used to check them with once a year which does not get sent out either. I have been here six months and am thinking these gages and masters are a violation of ISO. Am I correct?

Answer

The short answer is yes. The intent of ISO 9001:2015’s subclause 7.1.5 is to ensure that your company determines and provides suitable resources to ensure valid and reliable monitoring and measuring results, when evaluating the conformity of your products; and 7.1.5.2’s that is to ensure that your company provides measurement traceability when it is a requirement or when your company determines it to be necessary to have confidence in the validity of the measurement results. It seems that your practice for controlling the homemade thread and ring gages cannot fully fulfill those purposes. This is how I would address the situation:

  1. Assign a unique identifier to each homemade thread and ring gage. Maybe you can do that through your Document Control process.
  2. Ensure that those gages are protected from deterioration or damage when they are not in use.
  3. Have the homemade master measured by a service able to provide you with reliable certified measurements. That will make that gauge traceable to national or international standards. It will also allow you to demonstrate that the piece is fit for its intended purpose.  That means, you will be able to use this piece as the standard during the in-house calibration of the rest of the gages.
  4. Conduct an “in-house calibration” of each gage you use in production. You will need to issue an in-house calibration certificate for each one of those pieces, indicating on those documents how you achieve traceability to NIST or equivalent. If possible, identify the error for each one of those individual measurements you perform during calibration. Do not forget to include a statement indicating that the gauge was found suitable/unsuitable for use. That will demonstrate that each gage is fit for its intended purpose.
  5. Include ALL the gages in your calibration program. Make them subject to all the applicable provisions of your Quality System.

This approach will allow you to demonstrate that your thread and ring gages are properly controlled and maintained. If controlling those gages has not been an issue in the past, there is no guarantee that the situation will remain the same in the future. That is managing risk 😉

Aura Stewart

For more on this topic, please visit ASQ’s website.