QMS Improvement - Where To Start?
- Thread starter Kurt Smith
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Randy
Super Moderator
Isn't the creation of required documentation an improvement on current conditions? You're looking improvements in the mouth.
You define what and how much you want to do, put it on paper, create some kind of simple plan and then do it.
could be but it could also make matters worse. How much "documentation" is required? Doesn't the standard only have a limited number of processes that need to be documented -- 5 or 6 or something (too old to remember and too lazy to look it up).
When you say nothing is "documented" what do you mean? You run entirely without record of anything? That would be an amazing feat.
Step back and take another look. The documentation might not be formal, heck it may not even be paper, but I guarantee you have something.
As for documenting improvement, you don't need a SOP or WI. Just use a list. I have a list of improvement project we have come up with over time. Some we get to right away, some are just dreams. As we complete them, we just mark them completed. Can't be any easier than that.
Randy
Super Moderator
Here's a quick list I use as a check aid for Stage 1's or Gaps. It's not exactly 100% in the eyes of some so they can bust their fannies making a better list.could be but it could also make matters worse. How much "documentation" is required? Doesn't the standard only have a limited number of processes that need to be documented -- 5 or 6 or something (too old to remember and too lazy to look it up).
Mandatory Documents ISO 9001:2015
4.3 Clause Scope of the Quality Management System
5.2 Quality Policy
6.2 Quality Objectives and Plans for Achieving Them
8.4.1 Procedure for Control of Externally Provided Processes, Products and Services (outsourced processes)
Mandatory Records ISO 9001:2015
7.1.5.1 Record of Maintenance and Calibration of Monitoring and Measuring Equipment
7 .2 Competence Records
8.2.3.2 Product/Service Requirements Review Record
8.2.3.2 Record of New Requirements for Product or Service
8.3.3 Design and Development Inputs Record
8.3.4 Record of Design and Development Controls
8.3.5 Design and Development Outputs Record
8.3.6 Record of Design and Development Changes
8.4.1 Record of Evaluation of External Provider (supplier)
8.5.1 Record of Product/Service Characteristics
8.5.3 Record of Changes on Customer’s Property
8.5.6 Record of Changes in Production/Service Provision
8.6 Evidence of Product/Service Conformity
8.7.2, 10.2.2 Record of Nonconformity
9.1.1 Monitoring Performance Information
9.2.2 Internal Audit Program and Results
9.3 Management Review Results
10.2.2 Nonconformities and Corrective Action
Non-Mandatory Documents/Procedures ISO 9001 (suggested through commentary)
4.4 QMS Manual (all section 4)
4.1, 4.2 Determining Context of the Organization and Interested Parties
4.1.1, 4.2 Determination of Climate change impact
6.1 Procedure for Addressing Risks and Opportunities
7 .2, 7 .3 Competence, Training and Awareness Procedure
7.5 Procedure for Control of Documents and Records
8.2 Sales Procedure
8.3 Procedure for Design and Development
8.5 Procedure for Production and Service Provision
8.5.4 Warehousing Procedure
9.1.2 Procedure for Measuring Customer Satisfaction
9.2 Procedure for Internal Audit
9.3 Procedure for Management Review
10.2 Procedure for Nonconformity and Corrective Action
Good list for Mr. SpinDr to start with.
Kurt Smith
Involved In Discussions
Having someone else in management who understands and respects quality principles is already a major win. My biggest difficulty here is getting the ownership to understand that wanting to do better is not enough when no one understands or will own the work that needs done.
The others have done a great job with the ISO requirements, following their advice is ideal. But the biggest thing you can do is working to build a "Quality focused culture" amongst your leadership and employees. And I know that sounds like corporate bullshit. I am fighting that constantly here as almost everyone in the building has actively avoided working for large companies, so they didn't need the corporate BS. But getting people to understand that the paperwork is being done for a purpose is the key to success. ISO, Lean, Six Sigma, TPM. They all fall apart if the people involved don't understand why it is a benefit to follow the rules. If they don't believe in the system, they will ignore it when problems come up.
They best advice I can give to starting a new ISO system is get a consultant. If you or your management doesn't have experience in quality engineering, a consultant service will save you weeks of pain. Plenty of them will have a blank quality manual that can be customized to your processes easily. And they have the experience to see what details you will need to change for your specific needs.
The problem is most people see that the "paperwork" serves no purpose other than "comply with ISO." "Consultants" can just make it worse if not the right person. If there is an actual business purpose for the paperwork, it's an easy sell.
We use purchase orders, for example, as it become part of a contract with the vendor. Plus, it's nice to know what the heck we bought.
Johnnymo62
USA Semiquincentennial
In the "Attachments List" tab in the blue section at the top of the page search for: ISO 9001-2015 Gap Analysis Checklist
This is available for anyone. It has a checklist and instructions.
There are others available also.
This is available for anyone. It has a checklist and instructions.
There are others available also.
JustAQualityGuy
Starting to get Involved
Fantastic
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