Relocation Requires Audit?

Question

One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 certificate, do they simply refresh their company location / address in their ISO 9001 certificate with the Notified Body or they actually need to go through a full scale quality system audit by the NB?

Answer

Yes. They do need to have a full scale audit. The reason is very simple, a business is a system. When you change the environment, you alter that system. A full audit will be an adequate representation of the scope and magnitude of the change, and will indicate if this supplier is still a reliable manufacturer. Think about your most recent home move, the family is the same, your belongings are the same; however, everything is different at the same time.

Aura Stewart

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Quality Progress’ Standard Issues Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about ISO 9001: 2015 and top management. You must be logged in to view the column.

And at this link, ASQ members may find additional articles published in Quality Progress about this updated standard.

Not an ASQ member? Consider joining.

Posted in ISO 9001 - Quality Management Systems, Other, Quality Progress | Tagged | Leave a comment

Quality Progress’ Standard Issues IATF 16949 Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about IATF 16949 subclause 8.5.1. You must be logged in to view the column.

And at this link,  ASQ members may find additional articles published in Quality Progress about this updated standard.

Not an ASQ member?  Consider joining.

Posted in Other, Quality Progress, TS16949 - Automobiles | Tagged | Leave a comment

DPPM Calculation

Question

Recently, there is a debate in my organization about Defective Parts Per Million (DPPM) computation.
Camp 1 – DPPM = (No of parts rejected / No of parts inspected) * 1,000,000
Camp 2 – DPPM = (No of parts rejected / No of parts received) * 1,000,000
We perform sampling inspection based on AQL.
Camp 1 insists they are correct and likewise for Camp 2.  Which is correct or more appropriate to reflect supplier quality?

Answer

This is not an uncommon question. If you look at the standard, they define the % nonconforming as the number of parts nonconforming/number of parts inspected x 100. If you are looking at DPPM, instead of multiplying by 100, you put in 1,000,000. This means that by your definition, Camp 1 is correct. This is also what was intended by the creators of the sampling scheme.

Jim Bossert
Sr Performance Improvement Specialist
JPS Hospital
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

Posted in Other, Sampling, Z1.4 & Z1.9 - Sampling | Tagged , , | Leave a comment

Customer ISO Status In Jeopardy?

Question

My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection data is available.
In his quality manual and processes he addresses “Time Studies” and “Statistical Process Control” but he refuses to record his inspection data because this “complicates and delays” his production. I told him this is a weakness in his QMS but he says it’s not. Will this issue jeopardize his ISO certification?

Answer

I would ask how the organization could present objective evidence with the requirements of Clause 8.5.1 including  – ‘shall implement production and service provision under controlled conditions.’

Charlies Cianfrani

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EHS Procedures and ISO 14001

Question

Do EHS procedure have to be managed under ISO 9001:2008 if the company is not ISO 14001 certified?

Answer

It depends – are the EHS procedures part of the QMS of the organization. If so, yes. Otherwise no.

Charles Cianfrani

 

Posted in ISO 14001 - Environmental Management Systems, ISO 9001 - Quality Management Systems, Other | Tagged , , ,

Special Process NCRs During Audit

Question

Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process.
One of the NCRs was “Some welders are not qualified prior to welding on product.”
As a matter of fact, our company has developed its own qualification program based on the our needs consisting of the following steps:
– The minimum requirement of least 2 years or more experience as a welder before starting the job.
– In class training for weld specifications, blue print reading, equipment, weld supplies, visual acceptance/ rejection criteria and equipotent TPM program conducted by our QE.
– Hands on exam – the result of this test is reviewed by a QE and weld supervisor without performing any bend test, pull test or other types of DT.
– Annual recert. program based on a written exam and weld coupons visual inspection results.

The CB auditor is asking us to send the coupons out to a certified lab for bend testing or having all the welders certified by AWS. Is that required per ISO 9001? As a side note, every time we design and develop a new model we conduct all types of crash tests, FEA and durability testing in design validation phase.
Answers

From George Hummel:

I would not accept the auditor’s comments.  He/she is consulting.

From Charles Cianfrani:

No. It appears that the CB auditor is adding requirements. The organization has a process, and if it is effectively implemented that should be satisfactory evidence of conformity.

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