Statistical Techniques Procedure - What should be included

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Mike S.

Happy to be Alive
Trusted Information Resource
#2
I don't have a stand-alone statistical techniques procedure and never have. I may mention the statistical techniques used in process documentation or a procedure document.

What ST do you use? Let's say it's sampling and control charts. Document your sampling plan and maybe your justification for using it. For control charts -- to borrow a phrase, just do it. If you feel you need to document it, write a SPC work instruction. Don;t make it any more complicated than it needs to be.

JMO -- other likely do it differently.
 

Jim Wynne

Staff member
Admin
#3
Hi,

Can someone share statistical techniques procedure or an overview of what this procedure should include?

Thanks,

Hila
The nature of the question seems to indicate that you feel you need a procedure but you aren't sure why you need one. I'm with Mike S. on this one--don't do it unless there's a specific reason for it. Documentation should never be created unless there's a clear purpose for it. When there is a clear purpose, you should also know, at least in a general sense, what it should contain. Tell us more about why the procedure is being created.
 

Jean_B

Trusted Information Resource
#4
@Jim Wynne
The origin is probably found as regulatory expectations from two commonly applicable sources.

ISO 13485:2016 states the requirement for procedures (there's also plans but let's exclude those) related to statistics in two clauses.

7.3.7 Design of development validation
The organization shall document procedures for validation of processes, including:
...
d) as appropriate, statistical techniques with rationale for sample sizes;

and

8.4 Analysis of data
...
The procedures shall include determination of appropriate methods, including statistical techniques and the extent of their use.

While 21 CFR Sec. 820.250 Statistical techniques.
(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.
(b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.

As such the flavor is likely that of enabling appropriate selection and correct application of statistical methods. You'd have a tendency to a 'catalogue' with criteria to select an appropriate method (e.g. try 'selecting a control chart' in a search engine and look at the images), and then another policy matter on what you find appropriate levels of statistical rigor to produce confidence (aha, assurance) or changes in trends (often loosely based in risk/reliability management). And then comes the eternal debate about which abstract parameters matter, and whether you are strict enough, 'should have seen it coming', or are using the 'best' method when multiple could apply.
 
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