Combating contamination

Q: We want to ensure that we are receiving clean containers to package our products. How can we improve our incoming inspection process?

A: You should encourage your vendor to ship only clean containers. Then, be sure that the shipping and receiving process doesn’t cause contamination. If you can determine the source or sources of the contamination, the best fix is to remove the cause.

If that approach is not possible and you have incoming containers that may have some contamination, then consider the following elements in creating an efficient incoming inspection process.

1) How do you detect the contamination?

Apparently, you are able detect the container contamination prior to filling them, or are able to detect the effect of the contamination on the final product. Given that you are interested in creating an incoming test, let’s assume you have one or more ways to detect faulty units.

As you may already know, there are many ways to detect contamination. Some are faster than others, and some are non-destructive. Ideally, a quick non-destructive test would permit you to inspect every unit and to divert faulty units to a cleaning process. If the testing has to be destructive, then you’ll have to consider lot sampling of some sort.

There are many testing options. One is the optical inspection technique, which may find gross discoloration or large debris effectively. Avoid using human inspectors unless it’s only a short term solution, as we humans are pretty poor visual inspectors.

Another approach is using light to illuminate the contamination, such as a black light (UVA). Depending on the nature and properties of the contamination, you may be able to find a suitable light to quickly spot units with problems.

Another approach, which is more time consuming, is conducting a chemical swab or solution rinse and a chemical analysis to find evidence of contamination. If the contamination is volatile, you might be able to use air to “rinse” the unit and conduct the analysis. This chemical approach may require specialized equipment. Depending on how fast the testing occurs, this approach may or may not be suitable for 100 percent screening.

There may be other approaches for detecting the faulty units, yet without more information about the nature and variety of contamination, it’s difficult to make a recommendation. Ideally, a very fast, effective and non-destructive inspection method is preferred over a slow, error prone, and destructive approach. Cost is also a consideration, since any testing will increase the production costs. Finding the right balance around these considerations is highly dependent on the nature of the issue, cost of failure, and local resources.

2) How many units do you have to inspect?

Ideally, the sample size is zero as you would first find and eliminate the source of the problem. If that is not possible or practical, then 100 percent inspection using a quick, inexpensive, and effective method permits you to avoid uncertainties with sampling.

If the inspection method requires lot sampling, then all of the basic lot sampling guidelines apply. There are many references available that will assist you in the selection of an appropriate sampling plan based on your desired sampling risk tolerance levels.

Another consideration is the percentage of contaminated units per lot. If there is a consistent low failure rate per lot, then lot sampling may require relatively large amounts of tested units. You’ll have to determine the level of bad units permitted to pass through to production. Short of 100 percent sampling, it’s difficult (and expensive) to find very low percentages of “bad” units in a lot using destructive testing.

3) Work to remove original source(s) of contamination to permit you to stop inspections.

I stress this approach because it’s the most cost effective in nearly all cases. In my opinion, incoming inspection should be stopped as soon as possible since the process to create, ship and receive components should not introduce contamination and require incoming inspection to “sort” the good from the bad.

Fred Schenkelberg
Voting member of U.S. TAG to ISO/TC 56 on Reliability
Voting member of U.S. TAG to ISO/TC 69 on Applications of Statistical Methods
Reliability Engineering and Management Consultant
FMS Reliability
www.fmsreliability.com

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Digging for the Root Cause, Six Sigma Forum Magazine, open access

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The Bug and the Slurry: Bacterial Control in Aqueous Products, ASQ Knowledge Center Case Study, open access

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Can we require ISO 9001 certification?

Q: My company has bought another company in Canada and we are outsourcing to them. They are not certified to ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements.  Do we have the legal right to require them to get certified since we are?

A: Thank you for contacting the ASQ Ask the Experts Program.  With regard to your question, there is no requirement in ISO 9001 that requires any organization or their suppliers to be certified by a third-party. Certification is only needed if it’s required by a customer contract/purchase order, or if an organization has opted to be ISO 9001 certified.

However, as an ISO 9001 certified organization, your quality management system must include controls to maintain control over outsourced processes. This requirement is stated in clause 4.1. The control over outsourced processes may include all or any of the following:

1.    Use of an approved suppliers list (see clause 7.4.1)

2.    An onsite supplier quality audit (see clause 7.4.3)

3.    Review and approval of equipment, processes, procedures, methods, and personnel qualifications for processes that require validation such as welding, nondestructive testing, heat treatment or others (see clause 7.5.2).

In summary, ISO 9001 certification is a management decision and not a requirement.  Organizations that follow the ISO 9001 requirements and have outsourced processes should have controls in place to manage those processes.

I hope this helps.

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

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

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Sarbanes-Oxley And ISO 9000, Quality Progress, open access

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“As Found” Calibration Data – Available for a Fee?

Automotive inspection, TS 16949, IATF 16949

Q: I have been an auditor of ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements since 1992 and recently began consulting hospitals who seek ISO 9001 certification.

My experience with auditing to ISO 9001 is mostly in the manufacturing sector. When I audited against ISO 9001 clause 7.6 control of monitoring and measuring equipment, I routinely included questions regarding the process for assessing the validity of previous measurement results when equipment did not conform to established limits. I found no real issues with this until lately.

Now, clients say that calibration service providers do not routinely provide “as found” data in the report that’s sent to clients/customers. I have been told that the”‘as found” data only becomes available to the client/customer for an additional charge (and it’s not cheap).

Obviously, organizations cannot comply with the ISO 9001 requirement to perform the aforementioned assessment without this data. Since this has only come to my attention recently, I am wondering about the ethics and legality of withholding specific information in the calibration report – unless an additional fee is paid.

Could you please provide some insight or justification for this business practice?

A: It is always a good idea to evaluate one’s suppliers. This requirement is in ISO 9001 clause 7.4 purchasing. The May 2010 Quality Progress Measure for Measure column, “Supplier Demand,” provides guidance on evaluating and selecting calibration providers accredited to ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories. In addition, the ILAC-P14:12/2010 policy document requires ISO/IEC 17025 accredited laboratories to provide measurement uncertainty data with the measurement results as of December 1, 2011.

The customer should specify their requirements in their purchasing documents for calibration. ISO/IEC 17025 has contract review requirements that accredited laboratories must meet in order to to comply with clause 4.4 of ISO/IEC 17025.

In order for the laboratory to make an out of tolerance decision, it has to measure “as found” data. Even if the laboratory does not report it, it is required to retain it per ISO/IEC 17025 clause 5.10.4.2, second paragraph:

“When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.”

So, for a start, it is a good idea to use ISO/IEC 17025 accredited calibration providers and specify the customer’s requirements. Some provide “as found – as left” data routinely. Others may charge because they may claim that it takes extra time. But, if a competing laboratory provides it as part of the service, the other laboratories will follow suit or lose market share.

If the ISO/IEC 17025 accredited providers have to make a compliance decision on an item being calibrated, why would they not record the data? Even if it’s not provided, they are required to retain it for future reference in case of an inquiry. Calibration providers (whether accredited or not) that do not provide “as found – as left” data should probably be avoided. One does not know if they provided a legitimate calibration or they “stickered” the calibrated item and produced a generic certificate.

Other laboratories complying with ANSI Z540-1 or ANSI Z540.3 requirements are also required to provide “as found – as left” data. Otherwise, they are not fully complying with Z540 requirements.

The September 2010 Quality Progress Measure for Measure column, “Calibration Evaluation,” discusses evaluating non-accredited calibration providers and what to look for when assessing them.

Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)
Medina, Ohio
www.emc3solutions.com

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Improved Gage R&R Measurement Studies, Quality Progress

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Assessing Failure — The effect of faulty measurement on previously produced products, Quality Progress

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The Prediction Properties of Classical and Inverse Regression for the Simple Linear Calibration Problem, Journal of Quality Technology

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Remote Auditing

 

Audit, audit by exception

Q: I am a consultant and I have helped a dozen of companies receive certification to ISO 9001-2008: Quality management systems–Requirements. A recent client requested a specific registrar that is different than the one I have used before. That registrar states that per ANAB, the stage 1 audit must be conducted on site at the company being certified. My prior registrar claims that they do not know of this requirement. After a review of the documents and records sent to them, they conduct the stage 1 in a teleconference. Who is right?

A: No one can speak for ANAB and the requirements they have for certification bodies (CBs) for each standard except ANAB. For some standards, ANAB documents specifically state that stage 1 audits can be conducted on-site or remotely. However, in some cases, ANAB requires CBs to apply for accreditation to use Computer Assisted Auditing Techniques (CAAT).

I would recommend that a representative of the organization seeking certification formally ask for an explanation as to why remote auditing techniques cannot be used to conduct a stage 1 audit for conformity to ISO 9001:2008.

For more information about remote auditing techniques for internal and external audits you may want to consider reviewing material in the book eAuditing Fundamentals: Virtual Communication and Remote Auditing published by ASQ Quality Press.

J.P. Russell
ASQ Fellow, ASQ CQA
ASQ Quality Press Author
Member of the U.S. TAG to ISO/TC 176 on Quality Management and Quality Assurance
Quality WBT Center for Education/J.P. Russell and Associates
www.jp-russell.com

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Know and Follow ISO 19011’s Auditing Principles
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10 Auditing Rules
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Abstract:By following ten guidelines, auditors can significantly improve the effectiveness of audits. Read more.

The Future of Quality Management Research
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