Use of Correction Fluid to Modify ISO 9001 QMS Documents

ISO documentation practices, requirements

Q: During a recent audit, I discovered that my supplier was using correction fluid and scrubbing out the training records of its employees with no control over the documents. I said that would be a major finding, but they state that there is nothing in ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements specifically telling them that they can’t correct records on the fly without any control.  Can you clarify this practice for me? I can’t find anything definitive in the standard.

A: This is an interesting question. Sometimes, people complicate standards rather than recognize them for the friendly guides they can be. It is true, as written in clause 6.2.2 of ISO 9001:2008,  that records for education, training, skills and experience need to be maintained per clause 4.2.2. However, the standard does not designate a specific process for this.

Clause 4.2.4 expresses a requirement to establish a documented procedure, and also states that the records should be legible. While the practice of using correction fluid or scrubbing out training records is probably not the best and most professional way of handling things, it’s not a cause for a finding of nonconformance.

Records which have a direct affect on customer products would definitely need better controls. However, I think in this case, you might find it wise to work with the supplier to find a better way of recording employee training. The records must remain legible, readily identifiable and retrievable. If that is what they are doing and product quality is not affected, there should be no major finding. A recommendation for continual improvement would be appropriate.

I hope this helps.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Z1.4: Selecting the Sample Size

Pharmaceutical sampling

Q: I work for a pharmaceutical company that manufactures soft gel capsules. What is the proper way to select a sample size when using ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes?

I’ll further illustrate my question with an example.  If one were to have a batch size of 20,000 units, according to General Inspection Level II, Normal, the corresponding letter code is “M.” In the master table for Acceptable Quality Levels (AQLs), the sample size would be 315 units.  If my AQL is 0.010 (with an acceptance/rejection number of 0/1 based on the table), does my sample size change to 1250 units? Or does it remain at 315 units?

Your assistance is greatly appreciated.

A: The simple answer is 1250, not 315 suggested for sample size letter M.  General Inspection Level II, Normal, shows that for a lot size of 20,000, a sample size code level of M corresponds to a sample size of 315.  For an AQL of 0.01, the arrow points to a sample size of 1250 (sample size letter code Q) to have the required AQL of 0.01.

The calculation of AQL is not dependent on lot size.  In other words, a sample size of 315 gives a minimum AQL of 0.04, so a larger sample is required to estimate an AQL of 0.01.

Q2: Could you please add another layer to your response? The reason I’m seeking additional clarification is that the first step in determining the sample size is to find the letter code and the corresponding sample size. To me, it feels like the first step should be to determine the AQL.

A2: Let me expand with a more technical explanation.  Attribute sampling is based on the hypergeometric distribution and is estimated using the binomial distribution (which assumes an infinite population size).

The basic formula for the binomial is:

2.1.2013 1

AQL and LQ for a given sample size (n) and defects allowed (x): 2.1.2013 2

If n=30, x=0; AQL=0.17%; LQ=7.4%:

2.1.2013 3

2.1.2013 4

If you are using Z1.4, your sample size is selected based on your lot size.  Then, you would pick the AQL you need based on the risk you are willing to take for the process average of percent defective.  If you decide to not use Z1.4, but instead use the binomial directly, then you are correct that you would decide on the AQL and lot tolerance proportion defective (LTPD) first, then calculate a sample size for c=0, c=1, c=2, and etc.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ CQE
Principal Statistician, BD
http://statisticaloutsourcingservices.com

Related Content:

Acceptance Sampling With Rectification When Inspection Errors Are Present, Journal of Quality Technology

Zero Defect Sampling, World Conference on Quality and Improvement, open access

Explore ASQ’s website for more case studies, articles, benchmarking reports, and other content about zero defect sampling.