1. Define, measure, and improve with ISO
Process
Define, measure, and improve with ISO
Mark Berron CQE, CSQE, SSBB
Perot Government Services

2. Value of the Process Approach
Focuses on results
not procedures
Courtesy: Kevin Gilson, “Process Auditing”
True, but you need a good process to get good results.
How many attended Kevin’s lecture last month?
While that is good for the auditor, your company needs to know if the process is working to achieve the results. So you have to focus on process and process steps.

3. What does ISO have to do with it. Section 0
What does ISO have to do with it? Section 0.2 of 9001:2000 (Process Auditing)
Even ISO has PDCA!

4. Monitoring and measurement of product
ISO clauses 8.2.4, 8.4, 8.5.1, and 8.5.2
Monitoring and measurement of product
Analysis of data
Continual improvement
Corrective action
ISO doesn’t tell you how to monitor or analyze the data, or how to continually improve, or how to do corrective actions. But, you have to address these requirements in some way in your processes.

5. A process defined
A process is a collection of interrelated tasks to accomplish a goal. Source: Wikipedia
Proposal/Project processes
Steps in Proposals, project monitoring, risk assessment
Business processes
Purchasing, Billing, AP, AR
Engineering processes
Manufacturing processes
Shipping/Receiving .

6. Five Basic Questions
Managerial Level – Audit results should make the auditor confident that management:
Knows what the process aims to achieve
Knows how to design and cause processes to achieve results
Knows that it is doing the right things
Knows that it is doing it in the best possible way
Is regulating performance
Courtesy: Kevin Gilson, “Process Auditing”
All of that’s fine, but what does ISO have to do with it???

7. Note that going from Airplane to Tower is more difficult, so why not work backwards.

8. The 6 questions to ask? CUSTOMER WHO is your customer?
WHAT are their requirements?
HOW will you meet them?
So instead of 5 questions I have 6, but the intent is the same. Start with the results, in this case, the customer or the end of the process.

9. The 6 questions to ask? PROCESS
4. WHAT is the process to meet the customer requirements?
5. HOW good are you doing it?
6. HOW can it be IMPROVED?

10. The 6 Questions to ask GO BACKWARDS TO GO FORWARD !!
START
CONTROL
IMPROVE
MEASURE / ANALYZE
PROCESS
CUSTOMER NEEDS
CUSTOMER
Keep schedule
Reschedule
Errors at shift end
No errors
Accurate result
Keep it simple
Make it simpler
Too many steps
No Bottlenecks
Quick Turnaround
Keep auto
Less manual
Steps take longer
Handoffs
EMERGENCY!
You could put “Result” for “Customer” as it is whatever the end product has to be.
Mark Berron, PWQuickie
Note: This method works better with an existing process, not so well in creating a process!! For that use group meetings.

11. Let’s go back to …. PROCESS The great thing about ISO is…
You probably have your processes written down and diagramed….

12. Process in need of “lean”

13. Here is a typical receiving process, cut short, but you get the idea.

14. Now let’s define the process to meet customer needs
First, what is your process providing?
Need metrics
Need way to get metrics
Need to analyze metrics
Wait, now you have a way to measure. If I know how to measure, I know if the process has improved!!!

15. Customer Services Process Map
This process looks complicated but is not. The hard part was to get everyone to agree to the steps. Then where measurements could be made.

16. The Project manager wants quick turnaround…
Ok, so metrics are established, now can you get the metrics? Had to consult with the database programmer to see if these were input.
Note clearly defined step, from Contract sent to Customer to Original signed contract to Contracts department.

17. Where are we going to put metrics if the PM wants good product from the supplier??
Need to show all processes? Go from Receiving to QC to Machining to Assembly to packaging to shipping???
If damaged, how many? How was it insured? Is it a critical part? Is it rushed?
If not what you ordered why not? How far off is it? What does the invoice say compared to the ship list?
What kind of discrepancy?

18. Where are we going to put metrics if the PM wants good product from the supplier??
And quick receiving ?
Add timing metrics too.

19. Ok, we know where we are at, and it seems ok. But….
The ISO audit revealed a critical supplier with supposed low quality is still being used. The audit found that no part stayed longer than 3 days in the QC rack. This was commendable, and the auditor asked how this was done. Upon interviewing the receiver revealed he would sometimes send the items on to the floor if it sat in QC too long. The machinists would correct the part.
7.4.3 Verification of Purchased product (at least)
A corrective action plan is being written but first the root cause must be found.
Let’s do some brainstorming….
The ISO audit brought out the problem. Why didn’t the company know about it?

20. The 5 Whys Why did the tire go flat? Why wasn’t there enough?
Why didn’t the owner fill it?
Why didn’t he see it?
Why don’t they have a process?
Because there wasn’t enough air in the tire.
Because the owner didn’t fill it.
Because he didn’t see it low.
Because he doesn’t have a process.
THEY NEED ONE!!

21. The moral of the story is….
So the audit revealed that even though we had a process in place, it was being circumvented.
Also, the measurements were in place, but mislead.
Moral is that even measuring the process may not reveal the problems. Need the internal audit function set up to catch that, plus an internal monitoring system outside of the audit process??

22. FIN

23. Questions ISO might ask in Receiving
How many shipments have been rejected in the last year?
How many parts have you rejected in the last week?
Following the PO, let’s see the documentation for the receipt of that part?
Did the receipt follow the process established?
How do you track non-conforming parts?
How do you know they are not used in the process?
Do you still accept parts that don’t meet the specifications?
Why?
Do you have waivers?
How do you keep track of your suppliers?
Is there an instance of a supplier going on the bad list?
Any ideas to make the process better??
For the “where are you now questions… ask , what is needed in order to answer those questions??

24. The 6 Questions to ask GO BACKWARDS TO GO FORWARD !! START CONTROL
IMPROVE
MEASURE / ANALYZE
PROCESS
CUSTOMER NEEDS
CUSTOMER

25. Ishikawa, if time permits.

26. Sample Ishikawa.