The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Elsmar Cove Discussion Forums Main Page



Slide 93 of 262


8.4 Analysis of Data

The company shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.....

8.4 Data Analysis
8.4 & 8.5.1 appear to be the same.
Includes the data accumulated through internal monitoring of processes and data collected from 8.2.1 and other sections. The data has to be relevant to customer satisfaction and/or dissatisfaction, conformance to customer requirements, product and trends, characteristics of processes, and suppliers.

8.5.1 shows more what actions you have taken from the 8.4 analysis and how they have worked - and what follow-up was done.

Element 8.4, states that your company must collect data to determine the suitability and effectiveness of your quality management system and to identify and improvements to it that can be made. This includes data from measuring and monitoring activities and other relevant sources.

The standard states that you must analyze this data to provide information on:
a) Customer satisfaction
b) Conformance to customer requirements;
c) Characteristics of processes, product and their trends;
d) Suppliers

In Section 8.4 there are some new requirements. Statistical methods from the 1994 version were cut up and dropped into several new locations. This is just one of them. The idea here is that management should gather process data, internal review data, corrective action reports, preventive action results, customer complaints, and any other source of information on how your quality system is performing.

This information has to be analyzed regularly according to a written procedure. The output of such analysis should summarize, at a minimum, effectiveness of your system, process trends, customer satisfaction, and conformance to the all important customer requirements.

You get to select the appropriate statistical methods to use for the analysis. As usual ISO 9004 is full of ideas for which methods to use.

Potential Audit Questions

1. What is the most important data to your quality system?

2. Does your management team use statistical methods regularly to analyze this type of data?

3. What statistical method do you match up with which type of data collected? (For example: using SPC with process data, correlation analysis with customer complaints, etc.)
Thoughts on what data is:

In so far as the topic of data goes, it's the same in both standards.

->The only thing I know is that a operator of Warehousing
->Department enters the information about the incoming item
->(for example, metal tube)-price, short description,
->quantity in SKALA, and the member of supply Department can
->obtain the information about the current stocks by means
->of opportunities of SKALA.
->I can not describe the functions of our program SKALA in

I think everyone has tried to respond as closely as they can without having more details.

Go to your IS people and ask them how they control the SKALA program and the data it accumulates. Both the program and the data it accumulates must be controlled.

**However - There is a definite question as to whether this actually falls under ISO requirements if you are only looking at number of items in stock or other 'non-quality related' aspects of your systems.

This said, if you use the system to account for any customer related product, it is definitely a 'quality' related issue (4.7 in the old standard and 7.5.4 of the new standard).

If you are already ISO registered (I assume you are because you cited the 1994 standard) you should be looking at what you have defined as quality records and controlled documents. In the largest sense, data is many things, including those cited above. But also, consider the following from the 1994 standard:
4.6.3 Purchasing data
Purchasing documents shall contain data clearly describing the product ordered, including where applicable:

a) the type, class, grade or other precise identification;

So - in this case, data is what is input into the purchase order or other purchasing document. Now consider this:

4.10.4 Final inspection and testing
....No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.

When I think of data, I think of a form or database where you are entering data. Data is typically variables. It can be a computer program or it can be inspection results. Even a pass/fail can be data. A test report can be considered data.


4.11 Control of inspection, measuring and test equipment

4.11.1 General
.....Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.
4.16 Control of quality records
....Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor shall be an element of these data.

The 2000 version of 9K says:

8.4 Analysis of Data
The company shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

a) Customer satisfaction (see 8.2.1),
b) Conformity to product requirements (see 7.2.1),
c) Characteristics and trends of processes and products including opportunities for preventive action, and
d) Suppliers.

If you look at 9K as a whole, and look where the word data is used, you should be able to look at your system and decide what is appropriate.

That said, consider:

Originally posted by Al Dyer:

Listen to Roger,
Data relates to electronic media.
1. CNC programs
2. SPC programs
3. Gage programs
The best example is from Roger, CNC programming. How do you control the electronic programs that tell the process how to function?

Documents are documents. When you think data, think computers and electronics.
Well, yes, sorta. TS 16949 pressed this I believe. It is common now for data to 'include' electronic files in a broad sense.

Roger said:

->"data" refers to programming information used to run
->machines (NC machines, for example).

This correlates with my interpretation in that these are all variables.

The thing to watch is what you look at in the sense of what is a document and what is a record.

1. A purchase order (which eventually contains data) is first a form. Even computer screens have controlled 'forms' such as database front ends. These forms are controllable as documents under 4.5 (now 4.2.3).

2. Then, when you enter data it becomes a 'quality record' controllable in accordance with the old 4.16 (now 4.2.4).

Roger and Al used control software (such as a CNC program) which you control as a document would be controlled - it is revision sensitive. Al specifically cited programs.

CNC data - input into the CNC machine is an input (as opposed to 'process' software such as an SPC program which processes data). It is variable data but I would not call it a record. We want to be sure we distinguish the CNC program (call it data or call it the input – some folks call the input into a CNC the ‘program whilst some call it data {either way they’re variables}) from the CNC machine’s interpreter.

Data taken to be analyzed in an SPC program is a process output and it is data. This data input into the SPC program is typically a 'quality record' and the data output from the SPC program is arguably also a quality record and data.

Let's look at an SPC program closer. Probably it is canned (many companies do not develop their own in-house SPC program) so you have very little control with the exception of the yearly upgrade that software companies depend upon. Whoever installs and maintains the software are typically responsible for the control aspect. You can verify output, technically, although with canned software this is a questionable issue - usually the company which wrote the software verifies the accuracy and 'correctness' of the software output.

If you develop your SPC program in-house it's output has to be verified AND the program has to be controlled like you would a procedure - history and revision control. BUT - the output of the SPC program is data - again, a 'quality record'.

So data can be many things. As I said, of more importance is how you classify something which is the determining factor of what you have to do to control it.

As a procedure or as a record.


View the Elsmar Cove Privacy Policy and Terms and Conditions