Building a Lean ISO QMS (Quality Management System) is about focus – less is more! Increasing focus means finding the vital few (i.e. critical) metrics that will focus all workers on the most important aspects of your business — customer satisfaction.
What does a Lean ISO QMS look like?
Most, if not all, clients desire on-Time Delivery (OTD), a reasonable price, and high-quality products. This indicates that they want their order at the time specified in the Purchase Order (PO), not at a promised date later than the PO or when you ship after your promised ship date. According to the PO, they want OTD. Your ISO QMS is not functioning if your OTD is not 100 percent.
Of course, they also want fair pricing, which means there should be no overnight delivery to make OTD, no quality defects corrected before delivery (since they shouldn’t have to pay for your subpar quality), no rework, no surplus inventory, and no other manufacturing wastes. The goal of a Lean ISO Quality Management System is to continuously eliminate waste to drive down costs, increase quality, and hit OTD 100% of the time.
Building both a Lean and ISO 9001 system requires increasing the process maturity of each Critical To Quality (CTQ) process in the ISO QMS and reducing waste.
How is Lean done?
- Improve (change) your structure
- Visualize waste through clear data, metrics, and expectations
- Increase worker capability
- Iterate waste out of the system
Opportunities for increasing process capability include examining maintenance effectiveness, management, labor relations, employee competence, quality–preferably the Cost Of Quality (COQ)—and inventory that results from delays, setup time, batch size, and supply chain effectiveness.
Lean ISO QMS Value
Throughput, one of any company’s fundamental requirements, must be the focus of all work centers when focused on OTD. Losses resulting from planned maintenance, unplanned maintenance, faults, rework, delays, and process effectiveness all lower throughput. Individually balanced operations with higher levels of precision can provide better control over these losses and boost total throughput.
Benefits of a Lean ISO QMS
- Builds teamwork
- Provides actionable data
- Focuses employees on CTQ processes
- Delivers value from your ISO system
- Enables higher levels of quality
How to Create a Lean ISO QMS
Building a Lean ISO Quality System requires teamwork with managers and supervisors acting as team leaders, identifying value-added and non-value-added activities, and developing clear process boundaries, effectiveness criteria, and communication that creates value chains within the organization. Let’s examine the three main steps to creating a Lean ISO QMS.
Lean ISO Project’s Scope
Finalize the project management scope first. The initial objective should be to convert the existing ISO QMS to a Lean ISO QMS. Find out your present employee competence, teamwork, data, metrics, CTQ procedures, and overall effectiveness levels. This is where you are right now.
Form the ISO Steering Committee
Second, an ISO steering committee should be assembled to transition to a Lean ISO 9001 Quality Management System. The committee should be comprised of key management personnel who are the process owners of the CTQ processes.
Proposed steering committee members:
- Top Management
Quality Management
- Product Realization Management
- Sales/Order Acceptance Management
- Design & Development Management
- Purchasing Management
- Shipping, Receiving, Warehouse Management
- Human Resources Management
- Preventive Maintenance Management
- Laboratory Management (Measurement & Instrumentation)
- Information Technology Management
Finalize the Lean ISO Project Plan
Third, finalize a project plan with clear milestones, deliverables, and action steps to ensure the project’s completion on time.
Expected deliverables for a working ISO QMS that adds value to the management team include:
- Reduced non-value-added documentation that does not work demonstrating a Lean ISO QMS derived from value-added activities, CTQ work performed, and CTQ data collected.
- Employee involvement demonstrates working value chains derived from teamwork, improved satisfaction, and people taking the initiative to drive results.
- Revised quality objectives demonstrating measures of improvement derived from management team leaders identifying value-added and non-value-added activities, developing clear process boundaries, effectiveness criteria, and communication.
- Data that tracks the performance of key processes will provide management with a formal method for continually improving each process and the overall operation.
These Lean activities are designed to provide actionable data that focuses employees on the CTQ processes to deliver value from your ISO system. A solid QMS foundation enables an easier transition to higher quality, effectiveness, and value levels.
Lean ISO QMS Project Plan
Improvement requires iterations. A lean ISO 9001 QMS is achieved through elimination and iteration. The core principles involve:
- Structure creates results
- You manage what you measure
- Visible waste gets eliminated
- Competent, capable workers deliver results
The project plan is designed to build structure, focus on results, identify non-value-added activities, and motivate workers to deliver results. Each core process, process criteria, and method is involved to increase the focus and effectiveness of the QMS.
Six Phases of Lean QMS Project Plan
At Bizmasterz, we implement a Lean ISO QMS project in six phases.
- Clause 4 Define Interested Parties, CTQ processes, and system scope
- Clause 9.2, 8.7 & 10 Define continuous improvement activities
- Clause 5 -7 Direct continuous improvement activities and record training
- Clause 8 Define all Product Realization activities
(Planning, Sales, D&D, Purchasing, Manufacturing, and Testing Equipment) - Clause 9 Develop monitoring and measuring activities
Preparation for ISO Certification
This is typically done in a six-month consulting engagement. Work is conducted both onsite and in our office in St. Louis, MO. Each phase is expected to include site visits and follow-up communication.
Each phase consists of:
- steering committee meetings to review progress,
- training, as needed,
- individual sessions with process owners,
- a small internal audit,
- management review, and
- action items for the next month.
Estimated Cost of Lean ISO QMS
The scale of the project affects the cost. To ascertain the project’s cost, do a Gap Analysis, which measures the level of work. The main objectives are throughput improvements through process capabilities, risk management, labor relations, and delays. A project’s ROI might increase by 20 times with a 1% improvement in throughput performance.
Want a Lean Quality Management System?
One that delivers your products on time, at a fair cost, and with good quality? If you have a lot of inventory (turns < 10), scrap, delays, large batch sizes (>1), delays (2-week lead times), poor OTD (< 100%), long setup times (> 5 minutes), or poor process capability (Cpk <1) then you need a Lean ISO QMS today. Contact us to see how increasing your focus would work at your organization. Lean is not expensive; not being lean costs you money today.
