Rescheduling an ISO 9001 Surveillance Audit

Schedule, calendar, timeline

Q: Our organization had its last external (third party) audit in December 2011 for ISO 9001:2008 — Quality management systems — Requirements. We planned to have our next audit the week of November 26, 2012, but the auditor has become ill and cannot come at that time.

Do we need to have our surveillance audit within one year of the last audit? I am considering rescheduling for the first quarter of 2013.

A: Thank you for contacting ASQ’s Ask the Experts.  With regard to your inquiry, surveillance audits are usually conducted by most registrars on an annual basis.  Your registrar has complete responsibility for ensuring the availability of their audit staff to conduct these audits as they are required.

In the event that no other auditors can be provided by your registrar, it would be their responsibility to ensure the audit is rescheduled to another mutually agreed upon date and, if necessary, extend your organization’s ISO 9001:2008 certification status as appropriate.

Your organization’s ability to maintain to an active QMS certification status should not be dependent upon the availability of the registrar’s auditor.  I recommend that you contact your registrar to confirm the next date for your surveillance audit.

I hope this helps.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

Related Content:

ISO 9000 and Organizational Effectiveness: A Systematic Review, Quality Management Journal, open access

The authors conduct a systematic review of empirical studies of the ISO 9000 standard’s impact. Most of the reviewed studies focused on positive impacts. This review highlights the need for more critical and diversified approaches to examining ISO 9000. It also reveals some of the practical implications of ISO 9000 for managers. Read more.

ISO Survey Reveals Increase in QMS Certifications, Journal for Quality and Participation, open access

According to the ISO Survey of Certifications, the numbers of ISO 9001:2008, ISO/TS 16949:2009, and ISO 13485:2003 certifications all increased in 2010. Over 1.1 million ISO 9001:2008 certifications had been awarded by the end of 2010, representing a four percent increase over 2009. Central and South America saw an 11 percent increase in ISO 9001 certifications, while 18 percent of certifications in Africa and West Asia were lost in 2010. The Far East represented the largest share of the increase in ISO/TS 16949 certifications, and Africa and West Africa saw the largest percentage increase in ISO 13485 certifications. ISO 13485 was also the only certification that saw growth in North America; North American certifications for the other two standards declined in 2010. Read more.

 

ISO 9001 Statutory and Regulatory Requirements

About ASQ's Ask the Standards Expert program and blog

Q: I manage the quality management program at my company according to ISO 9001:2008 — Quality management systems –Requirements.  I was hoping to find some assistance in the area of statutory and regulatory requirements.  Can you provide me with some help in regards to what this means in terms of the standard?

A: Statutory and regulatory requirements are product related.  They may be federal, state or local.  They would depend upon your industrial classification.  Once you have that, you can cross check the classification with the Code of Federal Regulations (CFR).  Since the CFR are subject to change, someone in your organization should be charged with the responsibility for researching updates (there are organizations that provide this service). As far as international is concerned, the country of destination would need to be researched.  Often, a customs broker can be of assistance here.

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner, Global Certification-USA
www.globalcert-usa.com/
Dayton, OH

Related Content:

Imaging Core Lab Takes Quality Beyond Regulatory Requirements With ISO 9001, ASQ Knowledge Center case study, Open Access

Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDA regulations, but it was missing a framework to help drive organizationwide improvement. MMI worked with an external consultant to create an integrated management system—a fusion of regulatory requirements with the ISO 9001 framework—and received certification to the standard in less than seven months. Read More.

Sarbanes-Oxley And ISO 9000, Quality Progress, Open Access

Critics say ISO 9000 doesn’t compare favorably to quality programs such as the Baldrige criteria, lean and Six Sigma. But ISO 9001’s emphasis on documentation is a major asset from a legal perspective. Quality professionals can help companies comply with Sarbanes-Oxley while enhancing their organizational status. Read More.

Z1.4 and Z1.9 in Micro Testing and API Chemical Analysis

Chemistry, micro testing, chemical analysis, sampling

Q: I work at a cosmetics manufacturing company that produces sunscreen in bulk amounts. When we make 3,000 kg of sunscreen, we will use that in 10,000 units of final sunscreen products which will weigh 300 g each.

How many samples do I need to collect from the 10,000 units to pass the qualification?

The products need to pass both attribute and variable sampling tests such as container damage, coding error, micro testing, and Active Pharmaceutical Ingredients (API)  failure. Almost 100 percent of final products were inspected for appearance error, but a small number of them should be measured for micro testing and API chemical analysis.

For Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes, we have to collect a sample of 200 (lot size of 3,201-10,000; general inspection level II;  acceptable quality level 4.0 L), and more than 179 should pass for qualification.

For Z1.9-2008: Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming, we have to collect a sample of 25 (lot size of 3,201-10,000; general inspection level II; acceptable quality level 4.0, L), to meet the requirement of 1.12 percent of nonconformance.

Which sampling plan should we follow for micro testing and API chemical analysis?

A: If the micro test is pass/fail, then you should use Z1.4. The API chemical test  probably yields a numerical result for which you can calculate the average and standard deviation. Then, the proper standard to use is Z1.9. If the micro test gives you a numerical result, then you can use Z1.9 for it as well.

One thing to consider is the fact that the materials are from a
batch. If the batch can be assumed to be completely mixed without settling or separation prior to loading into final packaging, then the API chemical test may only need to be done on the batch, not on the final product. Micro testing, which can be affected by the cleanliness of the packaging equipment, probably needs to be done on the final product.

Brenda Bishop
U.S. Liaison to TC 69/WG3
ASQ CQE, CQA, CMQ/OE, CRE, SSBB, CQIA
Belleville, Illinois

Related Resources:

Getting the Right Data Up Front: A Key Challenge, Quality Engineering, open access

Rational decisions require transforming data into useful information by appropriate analyses. Such analyses, however, can be only as good as the data upon which they are based. In this article, the authors urge that careful consideration be given, up front, to procuring the right data and provide some guidelines. Read more.

A Graphical Tool for Detection of Outliers in Completely Randomized, Unreplicated 2k and 2k-P Factorials, Quality Engineering, open access

With the increased awareness of statistical methods in industry today, many non-statisticians are implementing statistical studies and conducting statistically designed experiments (DOEs). With this increased use of DOEs by non-statisticians in applied settings, there is a need for more graphical methodologies to support both analysis and interpretations of DOE results. Read more.

ISO 9001, Control of Monitoring and Measuring Equipment

Audit, audit by exception

Q: In ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6,  there is a requirement which states: “When used in the monitoring and measurement of specified measurements, the ability of computer software to satisfy the intended application shall be confirmed.”

Do you have any guidance on how this can be established in an analytical laboratory?

A: To answer your question, I would first refer you to the note at the end of 7.6.  It reads:

“NOTE:  Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”

Now, that can sound confusing to some folks. So, let me offer you some direction.  To “confirm” (verify) your software’s abilities, you need a known standard.  I’m not referring to a standard that is traceable to national standards.  I’m referring to data you know should be revealed as a failure by your software.

For example: You have samples from 10 subgroups and, you know that one sample, when analyzed, will be found to be nonconforming.  You can use a separate source to determine what the Cpk is, or you can simply identify which sample is out of tolerance and by how much.  When you use this known standard to test your analytical software, the results will tell you if it is suitable for use.

Most software is designed with some sort of pass/fail testing option.  Nonetheless, using a proven standard to verify your software brings it down to earth and more applicable to your needs.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Related Content:

You, Your Job, and ISO 9001, ASQ Knowledge Center

SunPower Corporation’s ISO 9001 recertification audit was getting close. Seeking to communicate the upcoming audit to employees across the organization, senior management of the quality function asked for an article to be included in the company newsletter. The version presented here has been edited for use by any organization that might be trying to communicate the ISO 9001 message to all staff, regardless of functional responsibilities. Read More.

What’s Old Is New Again, Quality Progress

ISO 9001 revision planning is under way. Read more.

Z1.4:2008 inspection levels

Q: I am reading ANSI/ASQ Z1.4-2008: Sampling procedures and tables for inspection by attributes, and there is a small section regarding inspection level (clause 9.2). Can I get further explanation of how one would justify that less discrimination is needed?

For example, my lot size is 720 which means, under general inspection level II, the sample size would be 80 (code J). However, we run a variety of tests, including microbial and heavy metal testing. These tests are very costly. We would like to justify that we can abide by level I or even lower if possible. Do you have any advice?

The product is a liquid dietary supplement.

 A: Justification of a specific inspection level is the responsibility of the “responsible party.” Rationale for using one of the special levels (S-1, S-2, S-3, S-4) could be based on the cost or time to perform a test. Less discrimination means that the actual Acceptable Quality Level (AQL) on the table underestimates the true AQL, as the sample size has been reduced from the table-suggested sample size (i.e. Table II-A has sample level G of 32 for a lot size of 151 to 280, while General Inspection level I would require Letter E or 13 samples for the same lot size).

Justification of a sampling plan is based on risk and a sampling plan can be justified based on the cost of the test, assuming you are willing to take larger sampling risks. If you use one of the special sampling plans based on the cost of the test, it is helpful to calculate the actual AQL and Limiting Quality (LQ) using the following formulas.

You solve the equation for AQL and LQ for a given sample size (n) and defects allowed (x):

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

In this paper the authors consider the problem of estimating the number of nonconformances remaining in outgoing lots after acceptance sampling with rectification when inspection errors can occur. Read more.

Zero Defect Sampling, World Conference on Quality and Improvement

Zero defect sampling is an alternative method to the obsolete Mil Std 105E sampling scheme previously used to accept or reject products, and the remaining ANSI Z1.4-1993 which is still in use. This paper discusses the development of zero defect sampling and compares it to Mil Std 105E. Read more.

Capability Analysis

 

Pharmaceutical sampling

Q: Why is a standard capability analysis determined to be best represented by 30 pieces?

I have answered this question by explaining it best represents a normal distribution. But I wonder if this is traceable to an industry standard?

A: You are right that most people associate 30 pieces with the conventional quantity for performing a capability study.  Although I don’t know the origin of this number, I can tell you the following:

  • The number 30 has nothing to do with whether or not the population is normally distributed.
  • In many applications, the number 30 is insufficient to properly model the process.  For example, automotive industry standards published by the Automotive Industry Action Group (AIAG) in their statistical process control (SPC) and production part approval process (PPAP) documents define 100 pieces as the appropriate sample size for an initial capability study (based on 20 subgroups of five or 25 subgroups of four).

I hope you find this helpful.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
London Ontario
www.DevosAssociates.com

Related Content:

Statistics in Pharmaceutical Development and ManufacturingJournal of Quality Technology,  open access

An overview is given of the use of statistical thinking and methods in the research and development and manufacturing functions in the pharmaceutical industry. Four case studies illustrate how these issues work in real life settings. A synopsis of these issues concludes that the technical nature of pharmaceutical development and manufacturing offers opportunities for the effective use of statistical methods leading to both process-development understanding and product-quality improvement.

Build a Usable Process Capability Database, Six Sigma Forum Magazine, Open Access

Design for Six Sigma requires that designs meet customer needs without sacrificing quality. A number of statistical tools can be used to produce process capability data to enable development teams to design products that can be produced at reasonable cost on existing equipment. However, setting up and using a process capability database is poorly understood and as a result, it is seldom used. To create a successful database, it is necessary to get management support, build the right data structure, collect the right data, and use the data correctly. A correctly designed database will allow the product development team to focus its efforts only on those tolerances in which the capability is unclear or in which function or cost improvements can be achieved.