Definition of a Calculated Risk

Posted on January 11, 2012 by At-PQC™

How to apply the Calculated Risk Release form:

The Calculated Risk Release form (CRR) can be used to work around circumstances that cause a bottleneck, which is a tangible benefit to a Company that must meet scheduled events under controlled conditions.

The CRR is a controlled method to circumvent “temporary” problems. It does not eliminate the problem but it does allow the process to continue on a calculated risk basis until the problem is “closed”.

The CRR must display signature approval and must be made a part of the acceptance process to ensure that nothing is shipped with an open CRR, which is absolutely essential for the calculated risk release process to work. The CRR must be a component of a closed-loop system such as the nonconformance or change control system. Normally, processes and products are not accepted with an open nonconformance – apply the same restriction to the CRR.

The CRR must not be used when a configuration element is affected. The preferred form in that case is the “Bulletin” or “Request for Support” or “Engineering Change Order”.

The CRR is not a Request for Waiver or Request for Deviation because it is not going to disposition a “problem”. The CRR is merely a controlled method to work-around a problem that will fix itself before final acceptance.

The term “calculated risk” must not be applied to endanger any business operation  that affects quality. The meaning of calculated risk is limited to situations that can easily be fixed before its too late, like not getting on a timely basis an analysis report or certification report that is part of an acceptance function. There is no need to withhold something if it is withheld based upon an event that will fix itself before it is too late. The problem is, the Company can’t look the other way to fix minor problems. The Company must use a controlled method such as a Calculated Risk Release form. In all cases, the calculation must mean there is no real risk – the risk must be minimal.

Management cannot use the CRR to permanently waive a requirement. There are more appropriate tools for that circumstance, such as an Engineering Change Order.

Summary:

Use the CRR for any situation that does not affect configuration and is expected to fix itself before it is too late. The risk must be such that the expected outcome will be realized.
Of course, there is always the probability that the expected outcome will not be realized, which is the definition of calculated risk. If the expected outcome is not realized, the Company would rollover the risk into a Bulletin, RFS, RFW, RFD or other appropriate document as soon as possible to support the Customer and schedule.

We provide the Calculated Risk Release form in almost all of our document kits and our software quality management system Efficient QMS™:

Basic Quality Plan

Construction Kits

Distributor Kits

MIL-I-45208 Kit

ISO 9001 Kits

AS9003 Kit

AS9100 Kits

Efficient QMS™

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Support for Corrective Action Request

Posted on December 21, 2011 by At-PQC™

Corrective Action Request from one of our Customers in Reading, PA:

Hello,

Please find attached our QAR’s Corrective Action Request. We are under a lot of pressure to correct the problems and hope you can help us document a solution.

Sincerely,

Fred H.

Owner

Customer Findings:

Defects:

Major characteristic 103 on drawing. Three pieces out of 200, the GO thread gauge fails to pass through. Pitch parameter out of tolerance.

Major characteristic 106 on drawing. Dimension Diameter 0.062 +.002 -.000 oversized on 2 of 200 samples. NO-GO gage goes through the holes.

Total of five different pieces out of tolerance. Based on zero defects acceptance plan, the lot was rejected.

This corrective action request must be addressed prior to presenting the lot for re-inspection.

The results of re-inspection efforts are to be included in the reply to this request for corrective action.

Include in your response a description of:

  1. Root cause of deficiency

  2. Action taken to correct the deficiency

  3. Action taken to correct and prevent recurrence of root cause of deficiency

  4. Action taken to determine if other product is affected by the same or similar deficiency and action taken regarding susceptible product.

  5. Action taken to correct the weakness that allowed deficient product to be presented for acceptance.

  6. Target dates for implementation of identified corrective action.

End of Customer Findings.

History:

Our Customer explained their quality system was compliant with ISO 9001:1994 and wasn’t registered, and they haven’t had much time to work on it. We explained that most QAR’s are trained to apply the latest industry standard so upgrading the quality system would be a very big step in the right direction, and could account for several "root cause" findings.

We learned that our Customer relied on their Supplier’s CofC and didn’t perform "Receiving Inspection" because they never had a problem with them before, which was a decision made by a long term Employee.

We learned that our Customer relied on their Supplier’s process controls, which presumed their Customer cleaned parts before sending them for anodizing.

We explained that an up-to-date quality system involves all Employees and keeps their knowledge fresh regarding Company procedure. We tried to transfer knowledge that a Registered QMS is much better for a Company because it regularly confirms Employee knowledge and application of Company procedures and actually pays for itself in prevention and continuous improvement.

We know that ISO 9001:1994 is a bit old fashioned but it still requires "Receiving Inspection" that can’t be waived by any Employee. We know that the old ISO also requires "Supplier Control" and "Company Control" of its own processes.

Our Customer processed about 20,000 parts through anodize and only became aware of a problem when their Customer rejected the first delivery of 7500 parts.

OUCH – the cost to replace and repair the parts was well over 3 times the cost for ISO registration and 3 years of annual recertification combined.

Our assertion that ISO pays for itself couldn’t have been better dramatized. Two simple little things would have saved all this grief and expense:

  1. Company process controls that take into consideration "Foreign Object Damage", which is simply providing for cleanliness of parts delivered from one process to the next and protecting their condition.
  2. Application of all Company procedures, especially "Receiving Inspection", where all parts are screened to ensure compliance with Company requirements.

I personally love "Receiving Inspection", which is the cause of 80% of the grief that a Company experiences and the first line of defense to protect schedules, quality and the Customer. Most Employees are taught or inherently have the skills to keep Company products in compliance so internal discrepancies are rare, but involve non-Employee resources and things really change.

We quoted $200 for the corrective action project and the next day we delivered 14 each MS Office documents to help our Customer respond to their Customer request. Each document included a PDF to send to their Customer – here’s the list:

  1. action-item-rfs-1001-rev-orig.doc
  2. bulletin-rfs-1001-rev-orig.doc
  3. engineering-order-rfs-1001-rev-orig.doc
  4. management-meeting-report-rev-orig.doc
  5. nonconformance-report-1001-rev-orig.doc
  6. purchase-order-rev-orig.doc
  7. qms-00-build-to-print-quality-manual-rev-orig.doc
  8. qms-08-1-purchase-order-review-rev-orig.doc
  9. qms-08-purchasing-rev-orig.doc
  10. qms-09-receiving-rev-orig.doc
  11. returned-goods-disposition-rfs-1001-rev-orig.doc
  12. schedule-to-qms-registration-rev-orig.doc
  13. supplier-evaluation-rev-orig.doc
  14. supplier-quality-requirements-rev-orig.doc

Click here to open a copy of the Nonconformance Report that we used to summarize findings, root cause and corrective actions. The above documents were required to answer the 6 item list shown above in Customer Findings. We learned a long time ago that a good nonconformance report form should address all Customer concerns. In addition, any modern day QMS expects "follow-through", which is simply taking a subject as far as it can go by pursuing all avenues of activity.

Turns-out, the problem with the parts was dust particles trapped under the anodize and oversized hole from the Supplier.

We learned from our Customer that their response won the confidence of their QAR, who remarked, "We need more Suppliers like you…".

This level of service is just the tip of the iceberg as to the extent we go to make things right for our Customers.

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Eight Steps to Compliance

Posted on December 18, 2011 by At-PQC™

Senior Pilot for National Helicopters Ltd out of Australia looking for Operations Solution:

Dear Sir,

We are a small helicopter business in Australia and are looking for a quality management system that is easy to maintain and won’t be too costly. We don’t have a lot of time to develop a QMS and would rather apply something that is ready to use and easy to manage yet compliant with ISO 9001. Can you help?

Our Response:

Hello,

Thank you for your interest in our products.

We were faced with the same business problem and found a way to take the complexity and cost out of compliance with ISO 9001. Things were a little harder in our case because management wanted a pedigree for AS9100 and we had over 30 years of paper to manage from our existing quality system, which was MIL-I-45208.

I was quality manager at the time and was desperate to make things easier on myself as well as the people that had to convert from a simple to very complex quality system.

Out of a sense of self-preservation, I helped myself by creating a web-based management system where all our documents were centrally located and all our records were searchable, downloadable and printable from a database.

We lived with problems for years because of document control nonconformances that involved issue and recall. These problems caused extraordinary overhead expense and auditing nightmares. In addition, we dreaded transposition errors that messed with data analysis when we transferred information from our paper records to a spreadsheet.

I saw the writing on the wall when I heard we were getting new management so I invented Efficient QMS to solve my most dreaded problems with quality management and it helped the Company earn a 99% score from our AS9100 Registrar.

Everybody knows how to browse the internet so I focused on that common knowledge to make things easier on myself as well as our Company. The Registrar we hired loved eQMS because everything they needed to confirm our compliance to AS9100 was a point-and-click away. Our Employees and managers loved eQMS because all they had to do was login and browse to whatever they needed anytime from their desk, in the plant, on the road and during business conferences where realtime data is golden. We really enjoyed responding to Customer questions during technical meetings with Customers like NASA, Lockheed Martin, Goodrich and others that wanted intimate details for their projects.
We were always prepared with an overhead projector and a connection to the internet to show-and-tell in realtime during the meetings. Engineering representatives really enjoyed seeing raw data and analysis while they watched the screen.

We recommend $497 Efficient QMS™ software, which is located at:
Efficient QMS

eQMS takes the “sting” out of quality system maintenance and cost. We were finally able to eliminate nonconformances for document management and simplify things to the point where we hardly noticed the burden of AS9100 compliance – it was easy…

Our Customers really loved eQMS and our Auditors couldn’t praise it more. They told us our management system was in their top 10 best ever list.

Of course, we first created our AS9100 quality system in MS Office format then transitioned to eQMS, which means we have a paper-based template that you can use for your project. Most businesses are comfortable with paper and have a twinkle in their vision to transition to electronic documents, some day!

Browse the Starter, Bare Minimum, Lean or Comprehensive ISO 9001 QMS kits at:

$127 Starter Kit:
ISO 9001 Starter Kit

$197 Bare Minimum Kit:
ISO 9001 Bare Minimum Kit

$297 Lean Kit:
ISO 9001 Lean Kit

$397 Comprehensive Kit:
ISO 9001 Comprehensive Kit

Use the following link to learn about typical expenses for QMS registration:
QMS Registration Expenses

Here’s a link to a typical implementation schedule for ISO 9001:
Schedule to QMS Registration

The paper templates are easy to tailor to make them look as though you created them. Simply use MS Office to search for the word “your” then replace the word with your business name or logo. You could email your Customer a copy of your manual and implementation plan within the hour.

Here’s an 8-step guide to implementation:

8-Step Overview of QMS Implementation:

1) Tailor QMS-00 to display Company business information then read the quality manual and note each referenced document.

2) Skim each referenced document and note each additional reference then skim those documents (forms and procedures). Significant documents in the kit have now been skimmed or read except non-referenced documents, which are value-added and should be archived until needed.

3) Open file named “Schedule to QMS Registration” then prorate the dates to fit your Company’s improvement schedule. The first informal management meeting should establish the goal of compliance to the QMS and its schedule. The Company can immediately demonstrate their commitment to quality by sharing the tailored manual and schedule with Customers.

4) Skim file named Quality Systems Assessment then complete the first half of the assessment, which is to identify Company policies, procedures and forms that comply with the standard. Add references to existing procedures and forms to supplement the first half of the assessment.

5) Complete the second half of the assessment, which is to identify where in the production process the Company complies with the standard. References may include but are not limited to testimony from employees and/or specific references to work records such as purchase order numbers, part numbers, inspection and production records, change orders, contract reviews, management reviews, training records, etc.

6) In parallel with steps 4 and 5, facilitate a management meeting to establish the goal of compliance with the new QMS and its implementation schedule. Use form named Management Meeting Report to create meeting minutes. Record something in each section – especially closure of action items. Actions from management meetings should be tracked because they become evidence of continuous improvement.

7) Facilitate orientation meetings with all Employees and clean-up the facility using 5S:
Sort-Straighten-Shine-Standardize-Sustain. If desired, substitute “Straighten” with “Set-in-Order”.

#8) Assert compliance with the QMS. Certification of the QMS by an ISO 9001 Registrar is not mandatory but the Company must substantiate its assertions using the quality system assessment form.

We are hopeful this information helps your project and thanks again for your interest in our products. Our support is no-charge by phone and email.

Quality Control Plan
719-649-4242

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Compliance with Customer Flowdown

Posted on August 14, 2011 by At-PQC™

Customer Support Email Threads:

Subject: Compliance with SIP-016

Hi,

We need to comply with Lockheed Martin’s flowdown SIP-016. Attached is the SIP-016 for your review and input. Can you help?

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Response:

Hello,

Nice to teleconference with you about your Lockheed Martin project and thanks for your interest in our products and services.

I see that the Standard Quality System in Appendix A is a lot more than MIL-I-45208; in fact, we need to add quite a few more procedures to the MIL-I kit to make it compliant with SIP 016. What we see in SIP 016 Appendix A is the Build-to-Print version of the ISO 9001 standard.

“Appendix A” in SIP 016 is essentially a “lite” version of ISO 9001 (no design); for instance (a few examples):

SIP 016 1.1 is equivalent to paragraph 4.1 from the ISO standard.

SIP 016 2.1.1 is equivalent to paragraph 4.2.3 from the ISO standard.

SIP 016 2.2 is equivalent to paragraph 4.2.4 from the ISO standard.

SIP 016 3.1 is equivalent to Section 5.4.1 from the ISO standard.

SIP 016 3.2 is equivalent to 4.2.5 from the ISO standard.

The giveaway that SIP 016 is a “lite” version of ISO 9001 can be seen at 6.6.1 Corrective Action and 6.6.2 Preventive Action, which are right out of the ISO standard at 8.5.2 and 8.5.3.

Here’s a couple of solutions to consider for your improvement project?

1)
We’ll create a quality manual in one day that is compliant with SIP 016 on a paragraph by paragraph basis then we’ll accumulate applicable procedures and forms from our $297 Lean ISO 9001 kit. Procedures and forms in the ISO 9001 kit are agnostic – it doesn’t matter what business operation they are used in. We are hopeful the “more lean” kit will cost the same as the $197 MIL-I kit but the final cost of the SIP-016 compliant kit will probably be $297.

2)
Adopt ISO 9001 and take exception to Design and Development paragraph 7.3. We describe a Fast-Track and Self-Assertion implementation strategy for ISO 9001 that satisfies Customers like Lockheed Martin. In your case, see the Self-Assertion method and Lean Kit for $297:

http://www.quality-control-plan.com/iso9001-quality-system.htm#fasttrack

To learn about how long ISO takes to implement, browse the Lean Kit for link named “Schedule to QMS Registration”.

Summary:

ISO is a terrific stepping stone to more business with bigger Customers. You know how hard it is to “romance” new Customers into buying from Suppliers with an unknown or undocumented quality system. In your case, MIL-I is not an option because it does not address Management Responsibility, Continuous Improvement, Records Control, Engineering Change Control, Training, Resource Management and more that is listed in SIP 016.

We are here to help…

Chat with you again soon,

At-PQC

Pre-Customer Follow-Up Reply:

Subject: SIP Document

Hi,

Thank you for your response and input. I attached the “Survey Checklist” that was sent along with the SIP-016. I thought it may be useful to you. I got your second email and the name you want to use is Ok but we will probably change it to suit our needs. I also want to stay away from an ISO title because we just don’t have the time to get the certification. This QMS will be audited by LM. We have negotiated with LM for this work and we have already made a tested and working prototype. Now we are getting the QMS in place so we can start production. If possible, I would like to see the QMS kit “Enhanced MIL-I-45208” (or at least a completed table of contents) for review before committing. I do think we are leaning heavily toward your product. I’ll be in touch very soon.

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Response:

Hello,

Thanks for the information about the status of your project. We’ll begin the process and send you a draft quality manual for review.

Chat with you again soon,

At-PQC

Our Follow-Up Response:

Hello,

Sorry about the delay in our feedback about your project.

We saw this morning on our Calendar that we had an appointment in Denver to visit with another Company about their QMS improvement project. They loved our ‘lean’ approach to things and offered to become our Affiliate for eQMS through their website, which is a marvelous product because it allows a Company to operate an industry-compliant QMS with fewer personnel than their existing paper-managed QMS. Our Denver Customer is no longer afraid of ISO because of cloud computing technology (eQMS). They intend to assert compliance to ISO without going for certification for a couple of years.

Sorry again about the delay. We’ll get started tonight on your Enhanced MIL-I QMS. We plan to send a draft of the manual/system tomorrow.

Chat with you again soon,

At-PQC

Pre-Customer Comment:

I look forward to hearing from you today.

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Response:

Subject: Re: Status of Enhanced MIL-I-45208 Project

Hello,

We are hopeful that you received our emails with timestamps:

8:05pm
9:44pm

The 8:05 email has an attachment and the 9:44 email has a link to the Enhanced kit in our catalog.

I’m guessing our emails are in your spam folder because they were sent by quality-control-plan.com instead of mil-i-45208.com.

Just in case the internet glitched during transmission of the emails, here’s the content from both emails:

8:05pm email:

Hello,

We completed the enhanced quality manual except for renumbering paragraph numbers in the cross-reference matrix in Appendix A, which we’ll complete tomorrow.

Use the following password to open the attached demo manual:

*****

We renumbered paragraphs in our standard ISO manual and moved one or two of them to match paragraph numbering in SIP 016. We also removed content and references to ISO 9001 and renamed the manual for your project.

SIP 016 is definitely a “lite” ISO 9001. To see for yourself, browse the QMS-00 Build-to-Customer Spec Manual in our ISO 9001 kit:

http://www.quality-control-plan.com/iso9001-quality-system.htm#leaniso9001kit

Of course, your project needs the Lean Kit to comply with SIP 016, which makes the kit $297 instead of $197.

9:44pm email:

Hello,

Please click the following link to browse the contents of the Enhanced MIL-I kit:

http://www.mil-i-45208.com/#enhancedmili45208kit

Thanks again for the improvement opportunity.

New content:

We need to update Appendix A in QMS-00 to match SIP 016 paragraph numbers to complete the quality manual. We’ll keep you informed…

Hope this information helps your project.

Our Follow-Up Responses:

Hello,

Appendix A in the quality manual is complete and the demo doc is on the website:

http://www.quality-control-plan.com/mil-i-45208.htm#enhancedmili45208kit

Thanks again for the improvement opportunity.

Chat with you again soon,

At-PQC

Our Pre-Customer purchased the Enhanced MIL-I-45208 Kit and later asked for a little guidance to support other improvement opportunities – see below:

Subject: QMS

Hi,

I was wondering if you would be able to give some direction as to the order of implementation of the most important to the least important process in the QMS system. My thoughts are to start implementing the process procedures in Receiving then Purchasing and then perhaps Configuration Management, etc. What is your advise on this.

BTW, we got a thumbs up from LM on the manual submittal. Now we are ready to tackle the real tough part and that is the implementation of each process.

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Response:

Hello,

That’s good news from LM about your quality manual.

Use the following link to download a typical schedule to QMS registration that might provide some insight to the big picture. Prorate the dates to match your schedule. The “schedule” is one of our no-charge downloads but it doesn’t address the order of precedence for implementing QMS procedures:

http://www.quality-control-plan.com/docs/schedule-to-qms-registration-rev-orig.doc

If at all possible, follow the numbering scheme in the “Schedule to QMS Registration”. Number 8 in the “Description” column establishes your Gap Analysis or defines the current status of your QMS before your improvement project. Numbers 17 and 18 in the list establish a timeline to begin training for your new procedures. Item number 19 in the “schedule” may be too aggressive but it will eventually paint a picture about the status of the quality system after implementation of your new QMS. Keep a record of all corrective actions, especially the confirmation that each correction actually worked.

You need the before and after audit record to document your Company’s continuous improvement, which is similar to the calibration process for measurement equipment. The calibration procedure requires measurements against standards as received in Metrology and measurements as delivered after calibration is performed. The desire is that both sets of measurements are the same to establish a reliable tool and recall program.

The differences in the quantity and type of observations and findings between the initial audit and subsequent audits is proof that the Company is improving. The fact that corrective actions are working is another bonus that LM will love. Summarize effective corrective actions and differences between audits to make lots of points with Customers.

One good method of prioritizing QMS procedure implementation is to use the process map in Appendix E from your quality manual – follow its flow through the business operation.

Another good method is to implement QMS procedures according to their numbering system – QMS-01 – QMS-02 – QMS-03, etc…

It really doesn’t matter since you have 17 of them to get through – just don’t lose sight of the big picture. Of course, in your case, you should delete items in the “schedule” that are numbered 23, 24 and 25.

Hope this information helps your project. We wish you the best for your project.

Chat with you again soon,

At-PQC

Additional Customer Requests:

Subject: Research Activities

Hi,

Do you have available any documentation (QMS) for R & D work that would fit into the Enhanced MIL-I-45208 manual? We do a lot of quick turn around R & D for a variety of customers and need specific controls for design development, testing and implementation. There is some document control that must be adhered to. I picked up on this in the QMS-02 Configuration Management. Any help would be appreciated. We may have to keep this entirely as a separate document that we can present and follow for internal control.

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Responses:

Hello,

Yes, we have aprocedure that can be integrated into the Enhanced MIL-I kit, which is numbered QMS-17, Design and Development:

http://www.quality-control-plan.com/cart/catalogue.php?cat=2#designdevelopmentprocedure

We also offer a plan for validation of tools and molds, which is located at:

http://www.quality-control-plan.com/cart/catalogue.php?cat=2#validationoftoolsandmolds

You are welcome to make a list of documents from our catalog and we’ll quote a “kit” price to save you from purchasing individual documents.

We wish you the best for your project.

Chat with you again soon,

At-PQC

More Customer Inquiries:

Subject: Referenced Documentation

Where can I get referenced documentation such as MIL-HDBK-H-106 and MIL-HDBK-H-107 noted in “RECEIVING, IN-PROCESS AND FINAL INSPECTION SAMPLING PLAN”?

Kindest Regards,

Quality Control Manager
Grantsvill, MD

Our Response:

Hello,

www.assistdocs.com/search/search_basic.cfm is the repository for all Government specs.

Type the number 106 or the number 107 into field named “Document Number” then click then browse the list to find MIL-HDBK…

I’ll bet your Customer would rather see ANSI Z1.4 Sampling Plan. The Zero Acceptance Number C=0 Plan is in your kit, which is an alternate to MIL-STD-105 and ANSI Z1.4.

Hope this information helps your project.

Chat with you again soon,

Customer Inquiry:

Do you have any suggestions for completing the SIP-016 survey?

Kindest Regards,

Quality Control Manager
Grantsvill, MD

Our Response:

Hello,

We browsed the Lockheed survey and find that it follows paragraph numbers in SIP-016, which are duplicated in QMS-00.

I believe you can complete the survey by referring to paragraph numbers from QMS-00 plus additional references when available. For instance, the 4th bullet in Survey Requirement #2 specifies that you describe the order and interconnectivity of processes. In this case, your answer would be:

Quality Manual paragraph 1.1 and Appendix E

I find that survey bullet #4 is broken because it doesn’t match the same bullets in SIP-016 Apx A. You’ll probably give Lockheed Martin an “improvement opportunity” by pointing out that the survey doesn’t match the SIP (but don’t take the chance if their Auditor is “Darth Vader”).

I believe that your knowledge of the MIL-I QMS will be enhanced if you complete the survey without assistance, which will help you talk-the-talk and walk-the-walk.

If you desire, we will complete the first half of the survey.

Be aware that all modern surveys come in two parts. One part is to identify where your policies and procedures comply with requirements and the other part is to identify where you actually demonstrate compliance in your business operation for things like change control. You can also use testimony from employees and records from the production process.

Example about how to walk-the-walk for Purchasing:
Select one purchase order then add remarks in the survey about:
1) Who reviewed and approved the PO prior to sending it to the Supplier
2) Call the Supplier to verify they have the latest revision purchase order and specification(s)
3) Verify the receiving record is complete and the receiving inspector verified all purchase order requirements, including compliance with the PO and drawings and specs, especially material properties listed on the Supplier cert.
4) Verify parts are marked or ID’d with PO Number, Part Number, Revision, Date and Lot Number.
5) Verify the stockroom is under control and records match quantities and part numbers
6) Verify the item(s) listed on the PO has/have been issued and displays applicable info from #4 above plus the job number or project name.
7) Verify the assembly records trace back to the PO and lot number.

All modern-day Auditors are trained to follow-through as shown above. The follow-through could be in Calibration or Change Control or any business operation that affects product quality.

“Its amazing what you find when you start looking!” (my favorite phrase).

Chat with you again soon,

At-PQC

Additional Customer Inquiry:

Subject: AAR M1003

Hi,

We have a requirement from CSX asking for a QA system that is compliant to the AAR M1003. I think our manual should cover this and I’m asking for your input on this. Thanks

Kindest Regards,

Quality Control Manager
Grantsville, MD

Our Response:

Hello,

The $136 Association of American Railroads standard M-1003 (2011) is available online at:

https://www.aarpublications.com/Publications/Manual%20of%20Standards%20and%20Recommended%20Practices/Section%20J.aspx

I’m sure you’ll also need their 30 page assessment form. Find attached an older version of M-1003.

There are many Associations that rely on ISO 9001 as the foundation for their various specialty certifications. AAR needs a Company to first be compliant with the ISO standard then it can become compliant with individual AAR requirements.

Nadcap does the same thing with AS9003 and AS9100 to get Companies certified to perform individual specialties. The FAA does the same thing for each Type Certification.

Your Enhanced MIL-I kit is fully compliant with ISO 9001 because of your desire for Lockheed Martin business. You wanted to keep your ISO compliance quiet so as not to scare off management but here’s your chance to openly express compliance to ISO 9001.

After you get your AAR related work, I’d renumber your MIL-I manual to display ISO 9001 paragraph numbers then resubmit your manual to Lockheed Martin and AAR. This way you’ll be on the same page of music as all other ISO compliant companies. Take a look at our ISO manual to see how to renumber your MIL-I manual:

http://www.quality-control-plan.com/cart/catalogue.php?cat=1#iso9001qualitymanual-3

If you desire, we’ll renumber your manual.

Neat job you have…

Chat with you again soon,

At-PQC

We continuously assist our Customers by phone and email at no charge. Do you need help like this…?

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Questions from one of our Pre-Customers

Posted on August 13, 2011 by At-PQC™

General Manager out of Australia seeking solution to their quality management issue:

Hi,

Our business would like to move toward a basic, manageable quality system.

Our business is an Engineering company that designs industrial equipment, drafts drawings and then issues these drawings to third party manufacturers (local and overseas) to build and supply the product to us. We then support the installation of the product on site (typically by supplying an engineer, as opposed to the whole commissioning team).

Our Company manufactures one off items, usually never the same machine twice; therefore, we need strong processes, but things like six sigma are not applicable since we are not trying to optimize a manufacturing process so much as ensure quality and timeliness of the one off product.

So, I have some questions:

1. Which package is most applicable to our mostly Industrial equipment Engineering design and project management business?

2. How long does it typically take a small business to build the quality manual in the first place using one person? 1 month full time? 1 year full time?

3. What would the typical time input be to continue to maintain the QMS once implemented?

4. Is the package purchase price the only cost we need to pay to get a quality manual?

5. I do not feel we are large enough to pay to be externally audited at this stage and to pay the ongoing accreditation fee, but what are these costs? Your website references travel, we are in Australia, therefore is this a question I need to ask an Australian ISO compliance body?

What I want to avoid is paying the money, getting a folder full of templates that are not applicable, and then creating a monster that our small business can not keep up with. We have processes, I simply want to organize them, fill the gaps, have a process of improvement and be able to show the Client that we have a Management framework equivalent to ISO.

Regards,
General Manager – Business Development

Our Responses:

Hello,

Thank you for your interest in our products.

We visited your website to learn more about your business and products.

You asked:

1. Which package is most applicable to our mostly Industrial equipment Engineering design and project management business?

Efficient QMS is the most applicable to your project to avoid getting a folder full of templates that are not applicable and to avoid creating a monster quality system that your small business can not keep up with.

2. How long typically, does it take a small business to build the quality manual in the first place using one person? 1 month full time? 1 year full time?

The quality manual in Efficient QMS requires only a few minutes of your time to describe your business operation in Sections 1, 2 and 3. If you desire, you can add additional details about your business but that is optional. We offer MS Office quality manuals that are ISO 9001 compliant and they too only take a few minutes to replace the word “your” with your business name or logo. If you started from a blank sheet of paper to create a quality manual, it would take about a week to complete. The supporting procedures would take about a month to complete.

3. What would the typical time input be to continue to maintain the QMS once implemented?

Efficient QMS is maintained as you use it. There is no requirement for additional maintenance to keep it up-to-date, except to regularly back it up. Of course, you’ll need to create forms if you desire to transition from paper to paperless management but that is optional. You can keep using paper forms until the time is right to make the transition to paperless. I know a Company that still uses their paper Purchase Order to send to Suppliers but the Receiving Clerk fills-out an eQMS purchase order form to make things easier for Users (back-end data entry).

4. Is the package purchase price the only cost we need to pay to get a quality manual?

eQMS (Efficient QMS) is sold without paying for additional Users. You pay one time for all time. $497 less 25% discount for our 10 year anniversary.

5. I do not feel we are large enough to pay to be externally audited at this stage and to pay the ongoing accreditation fee, but what are these costs? Your website references travel, we are in Australia, therefore is this a question I need to ask an Australian ISO compliance body?

Typically, around $6000 is the initial cost for ISO 9001 QMS certification and around $2000 for annual recertification and about $4000 for the 3 year recertification. You could visit the following online courtesy portal to find a Registrar and costs in your neighborhood:

http://www.bulltek.com/Registrar_Assistance/registrarassistance.html

Or, you could search Google using the following keywords to find Registrars like BSI Australia and others…:

ISO 9001 Registrar + Tasmania, Australia

Efficient QMS will enable you to transfer your MS Office documents into eQMS using the built-in Process Maker. Here’s a short video in demo eQMS about how to do that:

http://www.as9100-quality-system.com/demo/index.php?content=dcc/create-new-process.php

Of course, we offer paper-based management systems but they don’t fit your need to keep things simple to organize, easy to fill gaps and continuously improve without the additional labor needed to maintain a paper-based quality system.

Demo eQMS has more content than normal because it has been used for years by Browsers. You can see exactly what you receive in the ISO version of eQMS using the following link:

http://www.efficient-quality-program.com/iso9001/

We designed Efficient QMS to be as lean as possible with only required documents to achieve QMS certification when desired. Our paper-based ISO management system has more documents in it than necessary for certification because of lessons-learned and continuous improvements over many years.

Here are some suggestions if you desire a paper-based management system.

We are an open-book website where you can evaluate the contents in our ISO 9001 Construction Company kit:

http://www.quality-control-plan.com/construction-quality-control.htm#ISO_Construction-Grade

We highly recommend our Basic Quality Plan kits because they keep things simple. The complete kit is partially compliant with ISO 9001 so it makes a good intro to the QMS. Here’s the link to the starter kit – browse down the page to find the Complete kit:

http://www.quality-control-plan.com/construction-quality-control.htm#starterbasicqualityplan

We are hopeful this information helps your project and thanks again for your interest in our products.

Follow-up Questions from Australia General Manager:

Thank you for your detailed reply, it sounds good to me so far, but a couple of the answers just raised a couple more queries for me.

1. If we purchase eQMS (Efficient QMS), is this ISO9001 compliant?

2. Do we need in addition to eQMS, the Basic Quality plan kit or is that included in eQMS?

3. If eQMS and the basic quality plan are both required, then what elements of the Basic quality plan are not compliant (ref: ” We highly recommend our Basic Quality Plan kits because they keep things simple. The complete kit is partially compliant with ISO 9001″)

4. Does the eQMS license cover multiple users and sites in the $497 less 25% fee? For example, lets say we have 5 employees in our Hobart office and 5 in our Honk Kong office, does this fee cover us for multiple users in multiple geographies? I read on your site somewhere something that suggested that it did not cover multiple users in different localities; so, just want to clarify.

I think that’s about all.

Our responses to follow-up questions:

Hello,

Sorry about the confusion – we listed a few alternative solutions. The Basic Quality Plan was intended only as an alternative to support your project. It is partially compliant with ISO 9001, which is more than enough ISO for many companies.

You asked:

1) Is eQMS compliant with ISO 9001?

Answer:

Yes, we offer several different versions of eQMS that are compliant with standards like AS9100, ISO 9001 and AISC with more on the way. We also offer a “shell” version of eQMS that contains only a few documents to enable a Company to transfer their existing quality system into eQMS.

2 & 3) Do we need more documents to make eQMS work for us?

Answer:

No additional documents are needed. Complete eQMS is fully compliant with a variety of industry standards and contains only the documents necessary to achieve QMS certification. You’ll see substantially more documents in our MS Office kits because a paper-based QMS seems to need more documents to achieve the same level of business maturity.

4) Do we need more than one eQMS license.

Answer:

No; however, one licensed copy of eQMS is required for each “profit center”. Only one license is required if all profit-centers use one copy of eQMS. ISO 9001 in Australia is the same ISO in the USA and China so it makes sense for global companies to pool their resources. We do not charge per User, which means each licensed copy of eQMS can be used by an unlimited number of Users.

Thanks for your continuing interest in our products. We are hopeful this information helps your project.

After these questions, the Browser became our Customer and we helped him install eQMS on a Hatchling Plan at Hostgator.com.

Our Customer’s project started August 8 and on September 22 they offered the following comments:

“We’re pleased to work with Quality Control Plan during the integration of Efficient QMS (eQMS) into our work processes. We found the cloud QMS to be flexible and the online support exceptional. We do not have an IT department and found the installation to be well within my skill-level as General Manager. There is a learning curve, but it is short, and the results that are achievable in a short space of time are impressive. We look forward to the continuous improvement that can be achieved through an integrated quality management system and thank quality-control-plan.com for providing us with a product that has allowed us to produce an ISO 9001 QMS in a fraction of the expected time.”

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Fast-Track ISO 9001 Implementation Strategy

Posted on May 7, 2011 by At-PQC™

The ISO 9001 quality system is quite a commitment and returns on its investment should be measured to ensure that it continuously improves itself to further increase profits.

The starter ISO 9001 kit is helpful to introduce management to the scope of a quality system improvement project. The introduction can be so informative as to scare away or convince participants to accept the inevitable culture shock to the business operation.

Many businesses operate with sufficient documents to easily transition to ISO 9001. Use the references to procedures and forms in the starter kit quality manual as placeholders to insert your existing business document names. This implementation strategy takes a little more time but makes the starter kit the lowest cost approach to obtaining foundation documents and necessary direction to implement an ISO 9001 quality system.

The starter ISO 9001 quality system contains quality manual, conformance checklist, management planning and employee orientation tools.

  • Use the Design quality manual in the starter kit if your business designs and produces or manufactures its own products.

  • Use the Build-to-Customer requirement quality manual if your business produces products or manufactures according to Customer contract.

  • Use the Service quality manual if your business provides a service such as installation, maintenance, management, GSA contractor – or other non-manufacturing business operation.

  • Select your manual then archive the remaining manuals. The differences between the different style manuals are the exclusions listed in paragraph 3.2 and applicable paragraph numbers.

It takes some time to use the starter kit to create an ISO 9001 quality system. If you don’t have the time, click here to browse the Lean kit, which can be used to objectively validate the Company’s assertion of compliance to the ISO 9001 quality system in the shortest possible time.

We credit purchase of the Starter kit after purchase of the Lean or Comprehensive kit – no time limit.

Click here to browse the Starter ISO 9001 Quality System, $197.

If your Company is not ISO 9001 compliant, the lean quality system kit will help your business to earn a QMS pedigree just-in-time for the next RFP that’s set-aside only for ISO 9001 Suppliers. Convincing a Customer to buy is much easier when a business can provide a pedigree from a Registrar that confirms compliance to the ISO 9001 quality system.

1) Fast-track implementation strategy:

A very handy feature of the lean QMS kit is its ability to pass the one-day desktop survey of an ISO 9001 Registrar, which is a bonus when a business has just enough time to respond to a Customer proposal that requires Suppliers to be certified or compliant with the ISO 9001 quality system. The Company can quickly and objectively earn a pedigree that confirms compliance to ISO 9001 by submitting the quality manual and required procedures and forms to the vetting process of an ISO 9001 Registrar – here’s how:

  1. Purchase the Lean or Comprehensive kit then tailor the quality manual to display the Company’s info.

  2. Prorate dates in file named "Schedule to QMS Registration".

  3. Assign key authorities to attend an orientation to view file named "QMS Introduction" or "Internal Auditor Training". Remember to create a log sheet of attendance from the kick-off meeting. Coaching by phone and email is no-charge At-PQC™.

  4. Hire an ISO 9001 Registrar and fast-track their desktop survey of QMS documents. The schedule backlog of the Registrar could be a bottleneck but hopefully there are more Registrars to choose from in your City or State.

Passing a Registrar’s examination of the documents in your ISO 9001 quality system isn’t a registration number but the pedigree offers independent verification that your intent is genuine and firmly establishes a timeline for your business to become a certified Supplier.

Fast-Track Goal:

Enable businesses to compete just-in-time with ISO 9001 certified Suppliers.

2) Self-assertion implementation strategy:

This strategy enables a business to send a quality manual to a concerned Customer within an hour of download – here’s how:

  1. Purchase the Starter, Lean or Comprehensive kit then tailor the quality manual to display the Company’s business name or logo.

  2. Prorate dates in file named "Schedule to QMS Registration".

  3. Send the quality manual and schedule to your concerned Customer with sales rhetoric about the Company’s intent to become compliant with the ISO 9001 quality system.

The self-assertion strategy isn’t as good as the fast-track strategy but it has more promise than no evidence of compliance to the ISO 9001 standard.

Click here to browse the Lean ISO 9001 Quality System, $297.

The Comprehensive ISO 9001 QMS kit has more documents because of lessons-learned and continuous improvement opportunities that we’ve encountered over a significant time (30 years with the most demanding management and Customers on the planet). The additional forms and work instructions help to present a mature business that has learned to measure performance to increase return on investments.

Click here to browse the Comprehensive ISO 9001 Quality System, $397.

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Finding a Consultant

Posted on August 12, 2010 by At-PQC™

Our response to Sterling Wire & Cable regarding the job of finding a consultant:

Consultants are savvy sales-people first and knowledgeable resources second and their personalities sometimes clash with their Clients. We did the “Consultant-thing” once and learned there’s good money in the business but living that battle day-after-day was not our cup-of-tea. We found our calling so that’s what we do and we share our experience at no-charge – we’re here to give honest feedback to people trying to get to their next action item in a business process that we thoroughly understand.

We learned the best way to find a Consultant is to search the Registrar logs for businesses in your area. Almost every Registrar likes to brag about their certifications so they display all the businesses that they’ve certified. Those lists are searchable so you can find businesses in your industry in your area that have the certification that you are targeting. Get your list of businesses then call them to see how they achieved their goal – everyone we’ve spoken with likes to brag about their achievement so they’re a good resource.

We provide the tools that are needed to get the job done without a Consultant – no matter what the task – you’ve got to do the work. You’ll spend more than $20,000 for a Consultant to help you achieve certification to an industry standard. You’re going to spend that much anyway in a short time via group-hugs and orientation meetings. No matter what, you’re going to need a subject-matter-expert. We suggest you spend 10% of the Consultant fee on certification of one of your employees to become an ISO or aerospace auditor, then you’ll have your expert to guide the transition process. Of course, you don’t need a certified auditor to make an expert on the subject. Since you already have to do the work then anyone can educate themselves about the project – click here to see our Auditor training slides and orientation slides to become educated.

People with a master degree or PhD always start from a place called “I don’t know” and learn to achieve their degree. There are no mysteries if you’re willing to do the work – everybody in the business has to do their share of the work to achieve certification.

Hope this information helps your project.

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Expenses for AS9100 Registration

Posted on July 6, 2010 by At-PQC™

Our response to a request from Powertronic Systems regarding the expenses to register an AS9100 QMS:

Service

 Days Initial Fee Annual Fee 3yr Recurring
Application Fee 0 600 0 0
Desk Audit 1 1200 0 0
Readiness Review 1 1200 0 0
Registration Audit 4 4800 0 4200 (3.5 days)
Report Fee 0 650 650 650
Surveillance 2 0 2400 0
OASIS Fee 0 500 0 375
Travel Expenses: 0 Cost Cost Cost
Totals: 8 8950 + Travel 3050 + Travel 5225 + Travel

Expenses for ISO 9001 Registration

Service

 Days Initial Fee Annual Fee 3yr Recurring
Application Fee 0 600 0 0
Desk Audit 1 1200 0 0
Readiness Review 1 1200 0 0
Registration Audit 2.5 3000 0 3000
Report Fee 0 650 650 650
Surveillance 1 0 1200 0
OASIS Fee N/A N/A N/A N/A
Travel Expenses: 0 Cost Cost Cost
Totals: 5.5 6650 + Travel 1850 + Travel 3650 + Travel

These expenses change from year-to-year and are influenced by the costs for travel.

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Changes in AS9100C

Posted on June 28, 2010 by At-PQC™

Changes in AS9100C

Goal and Objectives of Changes to AS9100:2009

• Emphasis on product and process improvement (e.g. risk management, critical items, project management)
• Expand the AS9100 scope to include Aviation, Space & Defense
• Provide additional focus on objective of on-time and on-quality deliveries
• Ensure AS9100 standard is compatible for use by all stakeholder segments and by organizations of all types and sizes
• Ensure AS9100 stays recognized by authorities
• Ensure extensive stakeholder involvement in revision effort by the use of a project management approach to solicit input and manage the revision.

Summary of Significant Changes

• 7.1.1 Project Management
New requirement for planning and managing product realization in a structured and controlled way.

• 7.1.2 Risk Management
New requirement of implementation of a risk management process applicable to the projects & products; responsibility, criteria, mitigation & acceptance.

• 7.1.3 Configuration Management
Moved from clause 4.3 to clause 7.1 and added details on the different activities to be covered.

• 7.1.4 Control of Work Transfer
Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on having a process for planning and control of transfer activities.

• Product quality and on-time delivery performance
Added requirement to measure "product conformity" and "on-time delivery" and take appropriate actions if planned results are not achieved. The intent is to provide a linkage between the QMS and organization performance.

• Process to be required to address control of Special Requirements, Critical
Items and Key Characteristics
Key characteristic requirements remain unaltered but a new concept is added to identify special requirements from the Customer or internal sources that require additional controls (e.g. risk management) that translates into Critical Items that may flow to Key characteristics for variation control.

• Formal monitoring of Customer satisfaction data
Added the requirement to monitor data and to develop improvement plans that address deficiencies. The intent is to promote continuous improvement of the product and Customer satisfaction.

• Requirements from regulatory authorities.
A general requirement has been introduced in 4.1 to address all the applicable statutory and regulatory QMS requirements in the organization’s QMS instead of keeping detailed requirements in chapters.

• First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed.
Production process verification "FAI" is the requirement to validate the production process’s documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it is part of product realization and is not intended to be a follow-on activity.

• Difference between Key Characteristics, Special Requirements and Critical Items.
Special Requirements are those requirements that have high risks to being achieved, which require their inclusion in the risk management process.
Critical Items, including key characteristics, are those items that have significant effect on product realization and use of the product, which require specific actions to assure they are adequately managed.

• ISO 10007 is referenced after Configuration Management.
ISO 10007 is included in a Note for reference only.

• ISO 9001 changes affect AS9100:2009.
The AS9100 standard has been updated to stay consistent with ISO 9001, which will continue to be the baseline. The changes being incorporated into ISO 9001 are considered an amendment and minor in nature.

• Length of time to transition to AS9100:2009.
30 months. Companies will be encouraged to upgrade on their scheduled audit cycle.

• New "Scope" statement suggests alternate registrations. If an organization applies multiple standards in addition to AS9100 such as AS9110 (Maintenance) or AS9120 (Distributor) then the registration requirements should be determined by
Customer and regulatory requirements. More than one standard registration may be necessary if the Company provides other industry-standard products and services according to its scope of business activities (i.e. a Company that manufactures
products and also sells maintenance services). Clause 1.2 Introduction outlines the new applicability statements for AS9100, AS9110 and AS9120.

• Deleted text from Clause 4.2.2 Quality Manual Relationships.
The deletion of the requirement to create a document showing the relationship between AS9100 requirements and the organization’s documented procedures was seen as adding no value to assuring product quality above the existing ISO text. Users of AS9100 will still need to identify appropriate documented procedures as an inherent part of carrying out an audit.

AS9100 Revision "C" Key Changes
• 6 Additions
• 8 Revisions/Relocations
• 3 Deletions

Detailed Description of Changes in AS9100C

Clause 1 – AS9100 Scope and Application
• Revision: Scope extended to include Defense as well as Aviation and Space.
Application guidance provided when AS9100, AS9110 and AS9120 are appropriate for use.
AS9101 will incorporate AS9111 and AS9121 audit requirements.
• Reason:
The AS9100 QMS is applicable to other complex quality management systems and would receive benefit from implementation including land and sea applications.
Possible additional recognition and synergies with NATO Allied Quality Assurance Publications (AQAPs).
• Considerations:
Increased use and improved understanding of when the various aviation, space and defense standards are applicable.

Clause 3.1 – Risk
• Addition: Define new term "risk"
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.
• Reason:
The understanding of risk is important for an organization to develop a proactive quality management system.
• Considerations:
Understanding this term is important to implement a risk management process in the applicable clauses.

Clause 3.2 – Special Requirements
• Addition: Define new term "special requirements"
Those requirements that have high risks to being achieved thus requiring their inclusion in the risk management process.
Factors used to determine special requirements include:
- past experience
- product or process complexity
- product or process maturity.
Examples include:
- performance requirements imposed by the Customer that are at the limit of the industry’s capabilities
- requirements determined by the organization to be at the limit of its technical or process capabilities
• Reason:
Improve understanding of "Special Requirements" and the potential chain of flow to "Critical Items" and to "Key Characteristics."
Ensure these important requirements are systematically addressed and linked to risk management activities by the organization.
• Considerations:
Understanding this term is important to implement special requirement processes in the applicable clauses.

Clause 3.3 – Critical Items
• Addition: Define new term "critical item"
Those items having significant effect on the product realization and use of the product (e.g. functions, parts, software, characteristics, processes); including safety performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed.
Examples of critical items include:
- fracture critical items
- key characteristics
- mission critical items
- safety critical items
• Reason:
Improve understanding of "Critical Items" coming from Special Requirements.
Ensure these items are systematically addressed and linked to risk management activities by the organization.
• Considerations:
Understanding this term is important to implement critical item(s) processes in the applicable clauses.

INTERRELATIONSHIP BETWEEN SPECIAL REQUIREMENTS, CRITICAL ITEMS, KEY CHARACTERISTICS AND RISK MANAGEMENT PROCESS

Clause 4.1 – QMS General Requirements
• Revision/Relocation: The organization’s QMS shall address Customer and applicable statutory and regulatory QMS requirements (previously located in the QMS documentation 4.2.1).
• Reason:
Clarify that the requirement is placed at the QMS level and not only at the documentation level.
• Considerations:
The concept of "basic QMS" may be used (processes applicable to all Customers / activities) but the documents such as Quality Management Plans that address specific Customers requirements shall be considered as part of the QMS.

Clause 4.2.2 – Quality Manual Relationships
• Deletion: Requirement to create a document showing the relationship between
AS9100 requirements and the organizations documented procedures.
• Reason:
Requirement adds no value to assuring product quality.
Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met.
• Considerations:
Auditors need to identify appropriate documented procedures as an inherent part of carrying out the audit.

Clauses 5.2/8.2.1 – Customer Focus/Satisfaction
• Addition: Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not or will not be achieved. (5.2)
Information to be monitored and used for the evaluation of Customer satisfaction shall include but is not limited to:
- corrective action requests.
- Customer complaints
- on-time delivery performance
- product conformity
Organizations shall develop and implement plans for improvement of Customer satisfaction that addresses deficiencies identified by these evaluations and assess the effectiveness of the results.
(8.2.1)
• Reason:
Establish clear relationship between the QMS and organizational performance in line with AS9100 strategy.
To promote continuous improvement of Customer satisfaction.
• Considerations:
Review of management focus and organizational process to measure Customer satisfaction and plan improvements.

7.1.1 – Project Management
• Addition: New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk within resource and schedule constraints.
• Reason:
Most aviation space and defense products are complex and involve multi-tier partners and suppliers.
This clause provides additional focus on upfront planning and the management of project plans throughout product realization.
• Considerations:
The organization must have a process to manage product realization planning to ensure quality and schedules are not compromised.
Project plans should be used to manage the successful completion of projects.

7.1.2 – Risk Management
• Addition: New requirement to implement a risk management process applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance. The concept of risk is integrated within the revised AS9100.
• Reason:
Risk Management was placed in clause 7.1.2 to provide additional focus on product risk during product realization.
• Considerations:
The organization must have a risk management process that addresses all of the applicable requirements, such as verification of chemical/physical test reports.
The definition of risk must be appropriately understood and applied in that process.
Risks must be successfully managed in the organization.

7.1.3 – Configuration Management
• Revision/Relocation: Moved from Clause 4.3 to 7.1.3.
Structured in line with ISO 10007 requirements.
• Reason:
Focuses configuration management on the product and how it is sustained throughout product realization.
• Considerations:
Some level of configuration management is expected for all products at all levels of the supply chain in compliance with exclusion criteria (see clause
1.2).

7.1.4 – Work Transfer
• Revision/Relocation: Moved from clause 7.5.1.4 (Production) to clause 7.1.4.
The organization must have a process to plan and control the transfer activities.
Expanded to cover permanent transfer (e.g. from one organization to another, from one organization to supplier, from one supplier to another).
• Reason:
Work transfer can occur at anytime during product realization.
Addresses problems that often occur during work transfers .
• Considerations:
A process must exist to control the transfer of work including planning and subsequent control of the transfer.

Clause 7.4.1 – Recognition of Supplier Quality Data
• Revision: Added note to recognize that one factor that may be used during supplier selection and evaluation is "objective and reliable data from external sources".
• Reason:
Recognition that the industry trend is to use externally provided supplier performance data (e.g. Online Aerospace Supplier Information System – OASIS, Nadcap)
• Considerations:
Note only

Clause 7.4.1 – Approval status for suppliers
• Revision: Added and provided examples of "approval status" (e.g. approved, conditional, disapproved) and examples of "scope of approval" (e.g. product type, process family).
The organization must define the process for supplier approval status decisions or changes.
• Reason:
Clarify that the conditions for using a supplier depends on its approval status.
• Considerations:
The process responsibilities and authority must be defined for this process.

Clause 7.4.3 – Validation of Test Reports
• Deletion: Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.
• Reason:
Misunderstood concept that was frequently misapplied.
Requirement was prescriptive, not applicable to all stakeholders (especially small organizations) and for all types of products and was subject to varying interpretation.
• Considerations:
The organization must verify test reports as part of the risk management process if it is making critical items where the material chemical/physical requirements are important.

Clause 7.5.1.1 – Production Process Verification
• Revision/Relocation: Moved from 8.2.4.2 (measurement) to 7.5.1.1 (production)
Requirement to verify production process documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g. engineering or manufacturing process changes, tooling changes).
• Reason:
Movement to clause 7 acknowledges that this requirement (previously called first article inspection – FAI) is not primarily a measuring and monitoring process but a process that will be used to assure product realization capability under controlled conditions.
Allows justifiable exclusion for unique and individual products.
• Considerations:
Validation of requests for exclusion (unique and individual products vs. production run).

Clause 8.2.2 – Detailed Tools and Techniques
• Deletion: "Detailed tools and techniques shall be developed such as check sheets, process flowcharts or any similar method to support audit of the quality management system requirements. The acceptability of the selected tools will be
measured against the effectiveness of the internal audit process and overall organization performance."
• Reason:
Requirement was too prescriptive – reference to specific tools in a "such as" statement is more appropriate as guidance material.
• Considerations:
Methods and effectiveness measures remain intact in the ISO text. Tools and techniques may still be needed to support the audit process.

Clause 8.2.4 –Sampling Inspection
• Revision: When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriateness for use (i.e. matching the sampling plan to the criticality of the product and to the process capability).
• Reason:
Numerous requests were received to improve clause 8.2.4. The comments ranged from it was statistically inaccurate to comments that it was too prescriptive.
• Considerations:
Validation of recognized statistical principles utilized.
Process used to determine criticality of product.

Allowable time for Recertification
Maximum 30 month Implementation from Publication date (January 2009).

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eQMS Background

Posted on May 22, 2010 by At-PQC™

I know that an effective quality program pays for itself over time and is an accepted expense for operating a business. I know this expense is considered “overhead” or the “cost-of-doing-business” and is usually the first to be cut when right-sizing. The last 10 years of quality evolution has shown me that Customers want professional-grade management in their Suppliers before they’ll consider them as candidates. Today, that means Suppliers must provide a pedigree that proves they are worthy of consideration by concerned Customers.

Customers and Suppliers have only one chance to do it right the first time. They have to invest their time and resources on good practices that will increase profits and continuously win new business from their Consumers. Customers and Suppliers have the same goal – perform as a team to satisfy their Consumers and increase profit margins.

My name is Frank and I’m a career quality manager from a diverse range of sensor and electrical hardware manufacturing for more than 30 years. I’m an employee like any other that desires respect and admiration by my employer. I think I earn that by doing more than expected all the time.

Early in my career I learned to live in 5-year intervals; that is, do it right the first time so it doesn’t need to be improved for at least 5 years. A silly notion, but everybody needs a goal, and after more than 30 years there are so many overlapping 5-year intervals that they’re all a blur.
I still live by the 5-year goal and I’m constantly being inspired by current events or something in history that could improve my job. I found the internet in 1989 and during the 90′s I witnessed the transfer of quality management knowledge to the internet. I joined the evolution in 1998 by releasing all my paper-based knowledge to the internet through www.quality-control-plan.com.

Over the years I’ve lived a lot of “the-flavor-of-the-month” improvement scenarios and I’ve read a lot of twisted guidance by so-called experts in quality management. One endearing book that has stuck with me is Zapp! The Lightning of Empowerment: How to Improve Productivity, Quality, and Employee Satisfaction by William Byham PhD and Jeff Cox (Author). You can find it on Amazon for about $12.00. When you read the book you’ll learn about dinosaur eggs that are laid by the inherent inefficiencies of any process that later hatch to eat your hard work to cause you to do it all over again.

Well, believe me when I say I have scars from the many dinosaurs that have chewed on me where it hurts the most. Such unforeseen grief that hatches when you least need it – just like being crushed by one of Murphy’s Laws.

One of those dinosaurs finally convinced me there must be a better way. One day I was psychologically slapped into submission by a resident Customer during one of their product release inspections. I knew that a few days ago I had a piece of paper that proved compliance to one of their critical requirements but somehow it got misplaced during filing. I threw a bunch of people at the problem but we couldn’t find it so I had to hold the shipment because it would never get past their receiving department if they didn’t have one 8″ by 11″ piece of paper. At that moment of despair I resolved to fix the problem – 99% perspiration and 1% inspiration – I resolved to scan every important document to PDF and store it on the server. Well, that fixed the problem but it created a few new problems and that got me to thinking about other electronic resources that could eliminate the grief that was inherent in my job.

After several years of effort and some mighty handy software programming from my guru buddy Brian, we created a solution that helps me when I’m on the road and from any computer in the company. I can now get a record to support the Customer and answer a question or look at the details of a procedure that was always somewhere else other than right where I needed it, exactly when I needed it. The vast majority of my job-related problems are solved and every Customer and Supplier that interacts with me and the solution wants one for themselves because they suffer the same way I used to suffer. I was finally inspired under the right circumstances to solve my everyday problems and I’m going to share it with everybody.

Ask yourself these questions: How much grief will I experience by the end of the day because of my quality program? Doesn’t my business need an Efficient QMS™ that eliminates dinosaur eggs to enable me to lay-back and finally enjoy the view?

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