Quality Progress’ Standard Issues Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about AS9100:2016. 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 standard.

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ISO 9001: 2015 Clauses 4.1 and 4.2

Inventory, Inspection, Review, Suppliers, Supplies

Question

Let’s start with clause 4.2. What level of detail is required here? Is “supplier” or “customer” sufficient, or is it required to drill down from there to specific suppliers or customers? We have hundreds of suppliers and many more customers. Regarding 4.1, thinking about working this from the bottom up. Each Leader (supervisor, manager, director) will review processes under their control and identify issues related to those processes. Those processes can have internal and externally related issues. It’s the hope (plan) that this approach will cover all relevant issues (internal & external) that would impact our ability to meet the needs of the QMS -and- meet the needs of the interested parties (we are adding a column that identifies which interested party would be affected by the issue). As a side note, we’ll also do our risk analysis on all of the noted issues and roll the top items into the CAR/CI process. I feel I may be missing something with this approach, but it seems to mostly meet the requirements of 4.1 and 4.2.

Answer

4.2:  What level of detail?  The standard states, “the organization shall determine:

  1. the interested parties that are relevant to the quality management system;
  2. the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements.  [emphasis added]

Is “supplier” or “customer” sufficient?  It would be if all had the same requirements.  Assuming that they do not, you are required to “drill down.”  Customer satisfaction cannot be achieved unless you understand the individual requirements and monitor and review those requirements (which are an input to Management Review).

Furthermore, the list of interested parties goes beyond “customers & suppliers.”  Owners, employees, regulatory agencies, financial institutions, etc. to name a few have requirements as interested parties. These need to be addressed, as well.

“We are adding a column that identifies which interested party would be affected by the issue.” This is a good approach if the requirement is also addressed and you go beyond customer and supplier.

“Regarding 4.1, thinking about working this from the bottom up.” Once again, the standard states, “The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction…”

The key in this requirement is “strategic direction.”  If from working from the bottom up, you ultimately tie these external and internal issues to the organization’s strategic direction, there should not be a problem.

Be aware that your approach will not be familiar to your auditor.  In that case, you will need to fully explain your approach.

George Hummel

Here’s more information about this standard.

Quality Progress’ Standard Issues Column

ASQ Members: please find Quality Progress’ latest Standard Issues column here about IATF 16949 subclauses 7.2.3 and 8.5.1.5. 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.

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Relocation Requires Audit?

Employees, Training, Working, Learning, Duties, Tasks, DFSS, Innovation

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

Here’s more information about ISO 9001.

 

 

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.

Quality Progress’ Standard Issues IATF 16949 Column

Automotive, Assembly line, IATF 16949, Workers

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.

Defective Parts Per Million (DPPM) Calculation

Chart, graph, sampling, plan, calculation, z1.4

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

Customer ISO Status In Jeopardy?

Checklist, Conformity, Go/No Go, Inspection, ISO 9001

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

Find more information about this standard, here.

EHS Procedures and ISO 14001

ISO 14004, Environmental Management System, EMS

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

Here’s more information about ISO 14001.

 

Special Process NCRs During Audit

Welding, Weld, Processes, Automation

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 equipment 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 recertification 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.