I have just assumed the role of Quality Assurance Manager for a worldwide manufacturer and installer of transportation systems. As part of learning my new responsibilities and getting familiar the existing Quality Management System (we are currently ISO 9001:2008 certified), I have encountered some things that I think may need to be changed. Any opinions and/or advice would be greatly appreciated.
Here’s the issue; our current system for generating and tracking Non-Compliance Reports (NCRs) seems flawed. The way it is set up, all NCRs that are generated include a check box to show any Corrective Actions or Preventative Actions. If these boxes should be checked, the report is now called a NCR/CAR/PAR, all on the same form. The creator can then enter any actions taken. There is also a section to enter the “solution” for the non-compliance. The way this system works, it is not possible to create just a Corrective Action or Preventative Action Report (CAPA); they are shown as results, or solutions, to the NCR. Is this a good practice?
Are there better ways to utilize this process? In going through the report from last year’s third party ISO audit, it was mentioned that we needed to improve on this process, and that the NCR/CAR/PAR should be tracked separately. Any suggestions?
Generally, it is a good idea to use the same process for internal corrective action , a supplier corrective action, or a preventative action activity. This will ensure that all required steps will be followed. As a Senior Quality Director for a company, we had our computer system log each type separately as we set different deadlines for our corrective actions and preventatives.
The issue may be resolved by having the reporting system separate each type with aging timeless. I believe each type needs to be tracked and reported monthly as well as Management Review meetings.
Q: Under the standard ISO/TS 16949:2009 Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations — is it acceptable to allow an instrument user to request a calibration extension under certain circumstances?
Here are just a couple of examples:
The user is in the middle of a test that they don’t want to disrupt until completed.
Equipment is installed on a test vehicle that is at a remote location and is not readily available.
I should note we are an automotive supplier engineering facility doing advanced product development.
A: Here is my usual advice about calibrations:
1. The calibration frequency is both a matter of use and criticality of measures. Instrument companies err on the side of frequent recalibrations.
2. As with most standards based on ISO 9001:2008, the calibration frequency is an internal company decision as the requirement is:
• Process for calibration management
— Records need to show (7.6.2):
> Equipment identification, including the measurement standard against which the equipment is calibrated
> Revisions following engineering changes
> Any out-of-specification readings as received for calibration/verification
> An assessment of the impact of out-of-specification condition
> Statements of conformance to specification after calibration/verification
> Notification to the customer if suspect product or material has been shipped
Therefore, it is the supplier who determines the frequency of the calibration, as well as the standard to which they are using. If the supplier sets a frequency schedule they should follow it unless they get a concession from their customer.
I have done a large calibration study where an engine plant did the statistical analysis, which saved them millions of dollars to set optimal gauging schedules for an engine plant. I recommend that such a study be conducted by this company as soon as possible.
Voting member of the U.S. TAG to ISO/TC 176
Q: Can you please clarify a requirement in clause 22.214.171.124 in ISO/TS 16949 Quality management systems—Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations. The requirement is as follows: “A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans.”
We have a third-party auditor claiming that “product” means every part number. Our belief is that this is every product family, not every part number. As a company trying to stay in business, testing every part number is not feasible or cost efficient.
A: This is a controversial area as all production parts that conform to TS 16949 must be PPAPed which is, in effect, an inspection of each part that is produced. If parts produced have different part numbers depending on whom they are supplied to, then one PPAP would be OK. Also, it would be OK if the supplier can get a variance from its customers to the requirement “A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for ‘each product’ as specified in the control plans.” The supplier may want to seek a sanctioned interpretation by the International Automotive Oversight Bureau.
Voting member of the U.S. TAG to ISO/TC 176