Sample Size Calculations

BYOB
(Bring your own Bias)

MSB (Medtronic Spinal and

Biologics) Guidelines
MSB uses two guidelines: GQ146
Risked Based Lot Acceptance
Guidelines and PD047 Sampling
Guidance Document for Design
Validation and Verification of
Implants
Both are used as references for
teams to use in determining sample
sizes for testing or product
acceptance, but are not

If testing a particular feature this is

what I usually do

Sometimes I can glue together a strategy by combining

other Medtronic guidelines starting with the validation
policy.
First determine the required confidence and reliability
level

From SP4.27

and then tapping into

instructions (next 3 slides)
provided by a member of the
Medtronic corporate statistics
group that shows how to arrive
at a sample size through trial
and error using MiniTab

Sample Size For Normal-Distribution Tolerance Interval

Rev 0, Oct 12,

Goal:
Determine smallest sample size likely to result in a normal-distribution tolerance interval narrow
2011
enough to fit within the specifications
Typical Usage: Process Validation Activities (e.g. OQ/PQ)
Approach: Iterative approach to arrive at minimum sample size for demonstrating a level of process
performance at a specified confidence level using tolerance intervals. For PQ sample size applies to each of the
3 runs separately. The user must enter an initial guess for sample size (start at 10 if you dont know where to
start). Software is calculating tolerance bound(s). User tries different sample sizes until the tolerance bound is
just inside the defined specification limit(s). This is the minimum sample size necessary.
Needed Before Determining Sample Size:
Justification for using normal distribution assumption (e.g. probability plot of relevant historical data, scientific
rationale for distribution shape)
Estimate for mean and standard deviation (e.g. pull from historical data)
Desired Confidence Level (site requirement typically 95%)
Process Performance you need to demonstrate (often called Reliability Level)
Specification limits
Risk of wrong answer: Too small sample size causes unnecessary test failure. Too large sample size wastes
resources.
Be conservative: A larger sample size can protect you from failing unnecessarily. Boost estimated standard
deviation estimate by 25% to 50% and move the mean closer to the specification to use as the input values.
This will lead to a larger sample size, decreasing the width of the computed tolerance interval.
Questions: Contact your local Subject Matter Expert or LeRoy Mattson

Example (one sided spec limit): What sample size (N) is needed to prove 95% confidence than at least
90% within tolerance? Preliminary data showed data was normally distributed with sample mean (xbar) of 8
and sample standard deviation (s) of 1.5. Process has a lower specification limit of 3.

Minitab 16 Pathway and Inputs: Stat>Quality Tools>Tolerance

Interval

Example
Input 1 = 10 (Initial
Guess)
Input 2 = 8
Input 3 = 1.5
Input 4 = 95%
Input 5 = 90%
Input 6 = lower spec
only

Minitab 16 Outputs and User Decision on SampleAnswer:

Size Minimum Sample
Initial Guess
result

Size

=6

N=5 is below lower spec limit of 3

Try successively smaller
sample size until tolerance
bound is just > 3.0 (lower
specification)

N=6 greater than 3, therefore,

minimum sample size

Example (two-sided spec limits): What sample size (N) is needed to prove 95% confidence than at least
90% within tolerance? Preliminary data showed data was normally distributed with sample mean (xbar) of 9
and sample standard deviation (s) of 1.5. Process has a lower specification limit of 3 and upper
specification limit of 13. (note: mean is closer to UCL than LCL)

Minitab 16 Pathway and Inputs: Stat>Quality Tools>Tolerance

Interval

Example
Input 1 = 10 (Initial
Guess)
Input 2 = 9
Input 3 = 1.5
Input 4 = 95%
Input 5 = 90%
Input 6 = Two-sided

Minitab 16 Outputs and User Decision on SampleAnswer:

Size Minimum Sample
Initial Guess
result

Size = 13
N=12 is still above upper spec limit of 13

Try successively larger sample

sizes until tolerance bound is
inside both spec limits
(Lower>3 andUpper <13)

N=13 inside both spec limits, therefore,

minimum sample size

The main problem with that

method is the problem of
knowing the standard
deviation for items you
havent produced yet. If
similar to existing product,
use the standard deviation
for the existing product. If
not

and you just want to get an idea of

overall performance:

Suppose you want the product to have an average life of 4 years

(48 months)
But the lower spec limit needs to be 1 year because you have a no
fault return warrantee for 1 year (12 months)
Want a 95% confidence that 99% will last at least a year
Assume a fairly generous standard deviation of 12 months

Using the Sample Size For Normal-Distribution Tolerance

Interval MiniTab method see the following example.

Initial Settings
Try it with 10 Samples

Result
Not so good! With that sample size
there is 95% confidence that the
lower bound will be .227 months!

Increase sample size to 50

Better. Now we have a confidence
that the lower limit will be 13.6
months

Somewhere between 10 and 50 is

the minimum required sample size
Continued trial and error reveals the
minimum sample size to be 35

Discussion of Business needs while

walking through MiniTab example
What if you test to a safety factor.
Do you still need that many samples.
Try reducing the standard deviation and see
the effect on the lower bounds.