Rounding Numbers and Specifications

Automotive inspection, TS 16949, IATF 16949

Question

If I have a data collection form and the data inputs are whole numbers, should the report then use rounded whole numbers rather than to 2 decimals points?  I’d like to be accurate.

Answer

It depends on the specification.  If the specification is a whole number, then each reporting value should be in a whole number.  The issue comes in when inspection, measurement, and test equipment (IM&TE) gives a read-out in decimals, as they should.  (remember the requirement that the IM&TE should be more accurate than the desired result).

For example: if the specification is XX, then the test result should be reported in XX.  If the specification is XX.X, then the result should be reported in XX.X (one decimal place).

Not doing so can lead to problems.  If the specification is, for example 8 – 10, then a result of 8, 9 or 10 is passing.  If the IM&TE gives a result of 10.1 and you record 10.1 then you open the door for interpretation by others.  The best thing to do is define the recording of test results in the test procedure / method.

Once when I was being audited, the ISO auditor claimed that the company was accepting out-of-specification test results.  The specification was 0.01 max.  The test instrument gave a digital read out in the 4th decimal place and the technician record all 4.  The test result was 0.0102.  The auditor claimed that was over the max or 0.01. Boy did I have an argument with him (I won).  After that,the technicians were trained to round to the readings and record only to 2 decimal places (i.e. significant digits)  This was also added to the test instruction.

James Werner

Process Review Requirement in 9001?

About ASQ's Ask the Standards Expert program and blog

Question

Is there a requirement in the new 9001:2015 standards for annual monitoring/reviews of processes? What are any such requirements for process reviews?

Answer

First, there is no requirement to do anything annually.  Rather it is an expectation to do certain things such as calibration at least annually. The subject requirement is in section 9.3 Management review. Specifically section 9.3.2 Management review inputs includes at part (3) “process performance and conformity of product and services”.

What is commonly done is to create key performance indicators  (KPI’S) for each quality system process and these KPI’s are periodically reviewed (at least annually) during a management review.  Any process not meeting its KPI is looked into for improvement.

There are many articles and books written on this subject and available on the web.

James Werner

Click here for more information about KPIs and here for information about management reviews.

Internal Auditing Roles?

Manufacturing, inspection, exclusions

Question

I’m quality manager for R&D department and have several persons as Software Quality Assurance for our software development process. My question is can I act as Internal Auditor to audit the compliance of ISO 9001: 2015 requirements and the software development process execution?

Answer

Let’s look at this differently.  Say you are the quality manager and have several persons doing final product testing in a test lab. Clearly you are not impartial – you have a responsibility of the persons doing the testing.  Since you cannot be impartial, you cannot act as the internal auditor or even be on the auditing team.

James Werner

Click here for more resources about internal audits.

ISO 9001 and M & A

Reporting, best practices, non-compliance reporting

Question

I would like to know how ISO 9001 management system could facilitate a merger & acquisition. By speaking a common language and using the same exigencies, do you think ISO 9001 could facilitate this type of operation?

Answer

I’ve done this in the past but not with ISO 9001, instead using FDA Part 820 Quality System Regulation.  I created a checklist from the regulation and then audited the facility being merged / acquired.  This was done to determine the state of the quality management system and what needed to be done (including costs) to ensure the facility was in compliance.

James Werner