Ask the Standards Experts

ISO 9001:2008 Quality Manager Titles

Workplace safety, OHSAS 18001, work environments

Question:

Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such person holds a different title, e.g., specifically, Quality Representative?

Response:

I have seen this question come up at other times. Basically, I refer to how we need to understand the word “shall”. “Shall”, when used in the ISO standards, indicates a requirement.

Therefore, when clause 5.5.2 in ISO 9001:2008 says, “Top management shall appoint a member of the organization’s management . . . .”, then it is a requirement. There are good reasons for this. For one, the Management Representative must have the authority to perform those duties necessary for the successful implementation and continuation of a quality management system. Generally, a person in management knows the company’s business and has a working relationship with all the departments.
It is sometimes a practice to give a person a management title but limit their authority to that which is related to the QMS.

I hope this is helpful to you and thank you for sending your question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Question:

Hello,

I appreciate and fully understand your answer, however, I probably did not pose my question adequately. The responsibilities of the MR is clearly assigned to a member of management, and, in fact is the QM, but does not use the title “Management Representative”, but instead uses “Quality Representative”. So, in affect, there is no “MR” in the company. Is this an issue?

Thanks.

Response:

If you wanted to add verbiage to your Quality Manual or one of your documented procedures (i.e. Management Responsibility) which clarifies this you could. However, you do not have to.

The standard says your MR shall be a member of management. The standard does not direct you to make this an official “title”. It just needs to be clear that someone from management fulfills all the responsibilities of the MR. Those responsibilities can be in addition to that individual’s primary function.

It sounds like you are doing OK.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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

Recommended AQLs for Packaging Material in the Pharmaceutical Industry

Pharmaceutical sampling

Question:

Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry?
Thank you

Response:

Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to surface. The following table is a guideline that I have seen used successfully for a risk based approach to sampling. Based on the severity and criticality of the packaging materials, these guidelines can be adjusted up to down per your risk management process. Utilizing a c=0 sampling plan based on the binomial distribution, the sample size can be calculated using the following formula.

	Primary			Secondary
	Confidence (%)	Reliability (%)	Sample Size	Confidence (%)	Reliability (%)		Sample Size
Critical	99.5	99	527	99	97	151
Major	99	97	151	97	95	68
Minor	97	95	68	95	90	28

I hope this assists you.

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

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

ISO 9001:2008 Evidence of Conformity

Checklist, Conformity, Go/No Go

Question
ISO 9001:2008 states in 8.2.4 Monitoring and measurement of product: “Evidence of conformity with the acceptance criteria shall be maintained.”

When our plan identifies periodic inspections, variable or attribute, are performed, how can we show evidence without recording the specific results obtained during the inspection?

Answer
Thanks for contacting ASQ’s Ask the Experts Program. With regard to your question, please note that the primary intent of ISO 9001:2008, clause 8.2.4 is to ensure that the organization has established acceptance criteria and that a record is maintained to verify that product requirements have been met. This verification can be performed by documenting the results of actual measurements taken onto a spreadsheet, shop router, traveler, quality plan or other suitable means.

Another approach could be the use of a “Go” “No Go” gauge and a checklist to record inspection measurement results as pass or fail. There are many different ways of maintaining a record of inspection results. However, regardless of how measurements are taken, their results must be documented to provide evidence of conformance. Unless a record is maintained, there is no evidence that the inspection ever happened or that the product meets defined requirements.

I hope this helps.

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

Statistical Methods and Control Charts

Question:
My question is regarding a threading process. There is 100% inspection for go/no go check and about 5% rejection/rework. The batch size is 5,000 nos and is completed in 3 days of production. Two such batches are produced in a month.

What type of control chart should be used to monitor the process? How should the process capability be calculated in this case?

Answer:
The type of control chart first depends on what type of data you are measuring. If you are doing go/no go then you are limited to a “P” chart or a “C” chart. A “P” chart looks at % good (or bad). A “C” chart looks at the number of defects found.

If you are measuring thickness or strength, (something that can be measured), then you can use a X-bar/R chart or an X-bar/S chart depending on many samples are taken.

That is the simple answer; part of this depends on how you are taking samples and how often. If samples are taken at the start and the finish, then I would probably recommend the “P” chart.

If you can measure throughout the manufacturing process, and you look at the type of defects, then I recommend a “C” chart.

Ideally, if you can get measurement data, you are better off with the X-bar/R or the X-bar/S charts. These tend to be better predictors and it is easier to calculate capability.

With the capability for the go/no go data, you can get % defective, (or % good) and multiply that by 1,000,000 to get your capability estimate in defects per million.

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

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

Internal Lead Auditor/Auditor Qualifications

Audit, audit by exception

Question:

My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO 9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management system ….”

Our question is this; does the internal lead auditor and auditor have to be certified by an organization, or trained by a certified lead auditor? May a person read ISO 19011:2011 and with his/her experiences in his/her field then perform audit tasks as stated in section 8.2.2 of ISO 9001:2008? If yes, would an ISO registrar consider it to be a non-conformance finding?

Thank you in advance for taking time to answer our question.

Response:

Thanks for contacting ASQ’s Ask the Experts program. With regard to your question, it is important to know that ISO 9001:2008 does not prescribe any specific requirements for the qualifications of persons conducting QMS audits. ISO 19011:2011, provides guidance; not mandatory requirements for determining Auditor qualifications. As you are aware, an internal audit is one of the most valuable tools that an organization has to determine the effectiveness of its quality management system as well as to identify opportunities for improvement.

For this reason, it is essential that the personnel or consultants used to conduct audit activities, have the qualifications and experienced needed to provide these services. As a minimum, I would suggest that your internal audit personnel attend Auditor classroom training accredited by ASQ, RABQSA or IRCA. This training should be supported by arranging for their participation in future audits as an audit team member. This audit should preferably be conducted by an individual who has a current certification as an ASQ CQA or an RABQSA or IRCA Lead Auditor. Another consideration is to ensure that the Lead Auditor can provide an audit log as evidence of his/her past audit experience. The Lead Auditor should also provide evidence of their continued training to maintain their competency as an Auditor. Another key point is to ensure that the Lead Auditor has a working knowledge of your organization’s product line, processes or services. The importance of using trained and experienced Auditors can’t be overstated.

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

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

ISO 9001 Training Requirements

Reviewing confidential files, training records, human resources files

Question:
Are there specific training requirements for professionals (i.e. university graduates) in respect to ISO 9001: 2008? Are there any specific records that need to be kept on these individuals?

Response:

Good Morning,

This is an interesting question as it can be perceived as simple and that a short answer would be sufficient. However, in the interest of ensuring a ‘full’ answer, I will mention a few things about:

Qualifications
Records

Let’s begin with qualifications. You asked if there are specific training requirements in respect to ISO 9001: 2008. I will give you a yes/no answer. To be more specific, YES; everyone in an organization pursuing ISO compliance needs to be trained regarding their individual responsibilities. (See 6.2.2 Competence, training and awareness) This includes ensuring they are “aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives” (6.2.2d). 6.2.2e follows by saying you must “maintain appropriate records of education, training, skills and experience.”
I recommend that you read that entire clause and take note of the fact that it begins with “The organization shall”.

As for the Records, keep in mind that these are relatively normal Human Resources records. For example; if you have a machinist on your team, you would have records showing what schooling and/or training he/she has had to qualify for that position. That would also show what they can do in helping the team toward compliance.

Note it says in 6.2.2b that you are to provide training where necessary. For example; Someone completely new to the ISO standards would need to be made familiar with them and with their responsibilities. You would, of course, have records of such training.

Now, about the word “professionals” in your question. I am guessing that you are referring to your Quality Assurance (QA) or Quality Control (QC) personnel as well as the Management Representative (MR).

Section 5.5.2 of ISO 9001:2008 make it more than clear what the responsibilities of the MR. There is a lot there. However, the single requirement stated there is that your MR ‘shall’ be a member of the organization’s management. That is because this person must be able to make decisions, apply resources, and generate necessary changes in the company with reference to the QMS. They must also be in a position to let Top Management know where the company stands in quality and what, if anything, needs to be revised.

I personally would recommend that any/all individuals you have in a position of Inspector be required to complete the study and training necessary to pass the exam for ASQ Certified Quality Inspector. It would be beneficial for your MR to acquire certification via ASQ as a Certified Quality Technician. These are not ISO requirements. However, the study and/or training for such would help them to be better prepared and qualified to lead your team to successful ISO 9001:2008 compliance.

Thank you for contacting ASQ with your questions.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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

ISO/TS Exclusions

Manufacturing, inspection, exclusions

Question:

I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware. Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Response (Answered by Bud Salsbury):

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product. My company occasionally has purchased parts inserted into or added to the products made. Like bushings or threaded inserts, etc. We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Questions:

• IF there were permissible exclusions allowed, WHO would need to ‘approve’ these or ‘allow’ them to be exclusions? Would that be the registrar or someone else?

• IF there were permissible exclusions, would it be stated/depicted on the actual Certificate as such or only noted in the quality manual, for example?

• IF there were permissible exclusions, would it be an exclusion of the ISO CLAUSE? And/or PRODUCT? And/or SUPPLIER?

• Currently we list “the design and manufacture…” in our scope. Would we need to revise the scope to include ‘distribution’?

Response (Answered by Denis Devos):

Thank you very much for your question and your follow up.

In further response to your original question – if you are in the automotive industry, you will still be obligated to provide a Level 3 PPAP (as a default) to your customer for the product you are purchasing and reselling; whether you are design and process responsible or not.

Permissible exclusions are only granted for Clause 7.3 Product Design. Per TS 16949, you cannot be excluded from the requirements of Clause 6.3 related to process design. You can declare this exclusion yourself in your Quality Manual and your registrar will validate your claim during your registration audit. The exclusion will appear on your registration certificate. You can only be excluded from Clause 7.3 Product Design, (not process design).

Under TS 16949, you cannot exclude products from your registration if they are being sold to the automotive industry. Sometimes, a registrar will permit only a portion of your business to be registered and that would be reflected in the scope on your certificate: Check with your registrar. You cannot be exempted from any requirements related to supplier management, such as Clause 7.4.

Yes, you will likely have to include “distribution” in the scope of your registration; check with your registrar.

I hope this sufficiently answers your follow-up questions and you find this advice helpful. If you need anything further, please don’t hesitate to contact us.

Best Regards,

Denis J. Devos, P.Eng
ASQ Fellow
Devos Associates Inc.
London Ontario
www.DevosAssociates.com

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

AS9100 Temperature Control

Temperature control

Question:
There is a form for recording the temperature etc. of the measuring and calibrating equipment, but should there also be a requirement that the temperature be set at 20 degrees Celsius as that is the temperature in which all the calibrated equipment (gauge blocks etc.) would be accurate in?

Does an AS9100 certified company require a temperature controlled room for which to house all equipment and also in which all critical measurements are taken place?

Response:
The AS9100 states that environmental conditions shall be suitable for the calibration, inspection, measurement, and testing being carried out. If the measuring equipment is measuring close tolerance dimensions (typically .0001 inch) then expansion coefficients of materials must be considered including temperature and humidity.

Buddy Cressionnie
International Aerospace Quality Group Americas AS9100 Lead
Voting member of the U.S. TAG to ISO/TC 176
Southlake, TX

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

ISO 9001 Implementation: Clarifications on Interpretation

ISO documentation practices, requirements, records

Question:

We are in the process of implementing ISO 9001 for our Organization and have several questions regarding clarifications on the interpretation.

1. We have an Engineer Requirements Document (ERD) that is written for every single feature for the product. Sometimes it is just one ERD for a product. What should this be classified under? Currently we are classifying it as a Quality Record as this is generated every time we have a product or a feature. Initially we wanted to classify it as a Level 2 document, however it is not static and happens every time we come up with feature or a product. Is this the right way of classifying? This applies to the Marketing Requirements Document, drawings, specification etc.

2. Can a Quality record be amended, changed, or it should not be changed? If we follow the above process, the ERD will keep changing during the entire product realization process. Is this ok?

3. For control of external documents, is it sufficient that we have all the standards under one location in a server and have authorized personnel access it? Also, could you suggest how could be notified when any of the standards are changed or updated for a newer version? Is it a manual process to check the standards periodically or is there a way to have this automated using any service?

Response:

Thank you for contacting ASQ’s Ask the Experts program.

With regard to your first question, based upon the information provided, your Engineering Requirement Document (ERD) should be classified as a form. It is important to know that the purpose of a form is to provide a standard format for documenting information that may be related to in-house, customer or industry requirements. The completed form will then serve as a record to provide evidence that requirements have been met. Consider assigning a form number to your standard ERD format. Once this is accomplished, each ERD should be assigned a unique number such as a product, job, sales or contract number to facilitate tracking.

In response to the second question, a record is normally considered to be a static document and should not be changed or amended. In most cases where changes are made, revised inputs should be signed/initialed and dated along with an explanation for the change. As mentioned earlier, a record provides objective evidence that requirements have been met. Most companies use a work order, shop traveler or other similar form to document and communicate product requirements that will be needed by the process owners during product realization. This form may be updated as each process step is completed. At the end of the product realization process, the completed form (work order, shop traveler or other) serves as evidence that all requirements have been met.

Regarding question number three, please be aware that the method selected to store external documents is strictly an in-house decision. However, external documents must be identified and their distribution controlled (see ISO 9001:2008, clause 4.2.3, sub f). One of the best ways to ensure that your organization is kept informed about the availability of the most current edition of external documents such as industry standards, is to sign up for “Standards Alert”. This is a free service provided by the TECHSTREET Store at www.techstreet.com.

I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services
www.astontechconsult.com
Kingwood Texas

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

Method Validation of Analytical Procedures

Pharmaceutical sampling

Question:

I would like to ask if there is a specific acceptance criteria for an accuracy test, in method validation of assay procedure of a general pharmaceutical finished product, which has been agreed by ISO, ICH and USP?

Based on what I’ve read the acceptance criteria for accuracy may depend on the product itself. However, some ASEAN nations adopt a general acceptance criteria of 98-102% for accuracy test.

I would highly appreciate your response.

Thank you very much.

Response:

Let’s start with the objective and purpose of Analytical Method Validation to demonstrate that the analytical procedure is suitable for its intended purpose. The intended purpose will guide the decision for acceptance criteria. If we need the method to have accuracy within +/- 2% then that is what the acceptance criteria will be. This issue of +/- 2% for accuracy in ASEAN is misinterpreted. The source for that is from an industry Q&A about percent recovery of dissolved active ingredients.

Q1 : The method of determination of an amount of dissolved active ingredients and the method of determination of active ingredients in preparations (assay) in order to determine precision of the method, how much percent for rate of recovery should be accepted?
A1 : Percent recovery depends on concentration of the analyte in the sample. For example, if concentration of the analyte is in the range of 10-100 %, the recovery should be within the range of 98-102%.

Hope that helps!

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

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