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Quality Manual

What is thier experence with writing the QA Manual?


Quality professionals are known for creating documentation. Has the interviewee created or
updated a Quality Manual? What standard was the manual based on? Common answers to
this are ISO 9001, TS 16949, Mil-Q, Mil- I, ISO 14001 and AS 9100. Can they provide an
example?
Who approved the manual? This lets you know that others reviewed the manual and
believed the manual was appropriate to their business. If there was no approval process
then the interviewee skipped key steps for setting up the Quality system.

Sampling Plans
What is your experience in working with sampling plans? Please describe some of
the standards.
Quality professionals work with sampling plans. They are responsible for creating sampling
plans to support inspection needs. They should know the standards. They should
mention Mil Std 105e or Ansi Z1.4. They should also be familiar with zero acceptance
standards.
What is the difference between Mil Std 105 and Dodge Romig sampling plans?
This question really lets you know that the interviewee understands sampling plans. Both
are similar in that they create sample sizes depending on lot size, accept and reject criteria.
However Dodge Romig includes defect % history into the calculation. Dodge Romig normally
has smaller sampling sizes.
Quality Engineers and Managers should be able to answer these QA interview questions.

Data Analysis
Provide your detail knowledge on data analysis?
Quality assurance professionals use data analysis to make sound decisions for process
improvements. What courses have the interviewee taken on statistics and data analysis?
How does variation affect process improvement? Do they understand the two key methods
to improve processes? The two main methods are shifting the average and reducing
variation.
Where has the interviewee used data to improve process and products? Here I am judging
their statistical knowledge and looking for their abilities to apply the appropriate statistics.


SPC Questions
What is your SPC experience? Where have you used it?

Quality Engineers and Quality Assurance professionals should know SPC (statistical process
control) well. They should be able to give some examples of SPC applications during these
QA interview questions.
What does SPC do? What computer programs have you used for SPC? What
processes have you set up with SPC. When sample size is 1 how do you determine
the range?
In a nutshell, the SPC tool shows when a process is out of control.
There are many computer programs but one of the best is Hertzler.
With regards to the SPC processes, there are an unlimited number of
named processes.

Durig these QA interview questions, I look for their reasoning behind
using SPC on those processes. Did they find certain unstable
processes? Did they reduce inspection sampling with SPC? Did they
reduce process variation with SPC? Did they teach operators to use it?
Did they share charts with customers?



When sample size is 1 how do you determine the range for SPC?
This question provides extensive insight into the interviewee understanding the math behind
SPC. For most SPC, sample size one is not used. If sample size of one is used, the range is
determined by the average differences from the previous readings. If they refer to a moving
range chart, that answer is satisfactory.
What is CpK? What is the main assumption behind the statistic? What is the
equation?
Quality professionals use the statistic CpK to give a single digit number that represents how
well a process fits an engineering specification. A CpK number of 2 means the process is 6
sigma capable. The main assumption behind the statistic is that the process data is normal
distributed.
The equation is:
CpK = The lower value of these 2 equations
(high spec process average) / (3 * standard deviation)
(process average lower spec) / (3 * standard deviation)

Customer Interface
Have you ever dealt with actual customers? How do you deal with the customer
when there is a quality problem?
Quality professional addresses customers quality problems. These QA
interview questions lets me see their experience with customer interface.
What were the topics of conversation? How did the interviewee
treat the customer? How did the interviewee calm the customer
when there are quality problems.
Here I need to see an urgency from the interviewee. It is important that
the quality professional deals with the quality problem promptly. They
quickly call the customer or send an email when there is a problem.
Have you written formal corrective action letters to customers? After initiating
corrective action, what is the most important thing to do?
Formal corrective action letters should follow the 8D format. Quality professionals should
know this format. The most important thing to do with corrective action is follow up. Too
many times I have seen corrective actions were documented, actions were taken but 2
weeks later the permanent action disappears. Follow up is the most important thing to do
for corrective action.

Calibration
What is the interviewee experience with setting up a calibration system?
More QA interview questions deal with calibration because the calibration department
normally falls under the quality department umbrella.
Quality professionals should know the requirements for calibration. Have they ever setup or
enforce calibration rules? Have they ever created documentation for calibration? Can they
provide you an example of a calibration manual? A Quality Manager, QA Director or Quality
Engineer should know calibration requirements forwards and backwards.

Audits
What audits have you been involved with. What is important to recognize when
doing an audit? Why Audit?
Quality professionals conduct audits on a regular basis. When
conducting an audit it is important to recognize that audits are for
fact gathering. Audits make people nervous and a good auditor will
put the person at ease. The auditor lets the employee know there
will be no disciplinary action taken from the audit findings. The
audit tool is used for improvement.
If an employee is doing something different then the
procedure, what action should be taken against the
employee. Do you correct the employee on the spot?
Unless you absolutely know that the employee is doing something that will cause non
conformities, do not take any action against the employee. Discuss the issue with the
employee for more input. Do not take any disciplinary action. Do not correct them on the
spot. You document the findings for later review. The employee may actually have a better
process than the procedure. See below for more QA interview questions.



Design of Experiments (DOE)
What is your experience with DOE. Where have you used DOE to improve the
process. What is a DOE used for? What is the main statistical test behind DOE?
Most QA professionals do not know DOEs. Im wary of those who make stuff up on these QA
interview questions. A DOE is a systematic method of conducting engineering tests. If there
are multiple factors being studied, a DOE will find the principle factor and interactions with a
minimal amount of engineering runs. The main statistic behind a DOE is the f test.
Reliability
What is your experience with reliability? What data distributions do most
reliability studies follow?

Again most QA professionals do not know about reliability. However
if they have statistical training they may be able to answer the
above QA interview questions. Reliability is monitoring a product to
predict its useful life. Mean Time to Failure, MTTF or Mean Time
Between Failures, MTBF is the main statistic. Reliability normally
follows the Weibull or bathtub distribution.

Software
What statistical software have you use?
During these QA interview questions, most will reply with Microsoft Excel. Its a benefit to
have those individuals who have used Minitab, JMP, SAS and / or Hertzler. It shows they
have been exposed to other software and they can help the company select sound software
tools for improvement.
What other Quality Software have you used?
Have they used special software for corrective actions such as 8D Manager? Have they
use Snap Sampling Plans for creating inspection sample plans? Have they used software for
brainstorm generation such as SWOT Manager? Have they used flow charting software for
creating documents? Quality assurance professionals should know a wide variety of software
for these are tools that improve processes and products.

Gage R&R
What is the importance of gage R and R studies?
A Gage R&R, (reproducability and repeatability) study exposes the
measurement error within any measurement system. It tell us how
much error the operator is contributing, how much error the
instrument is contributing and the amount of natural error. It is
desirable to have machine and operator error less than 20% of the
total error.