“Slowness to change usually means fear of the new.” – Philip Crosby
Change (permanent or temporary) is inevitable and is part & parcel of our lives. It may be the government’s economic policies, global warming, pandemics like COVID, emission norms transition from Euro IV to VI or LGBT rights. The list is endless. The important thing is ‘Are we willing to change and adapt to the changing environment?’
The industry runs for 365 days/24 hours, and can not simply reschedule production, what is lost is lost forever.
In this competitive environment, every organization is looking for opportunities for improving QCD (Quality, Cost, Delivery) through sustained quality, improved efficiency and reduction in costs through improvement in design, processes, material & manufacturing processes.
Frequent changes in 4M’s & design are inevitable in the manufacturing processes. However, it is the 4M change control implementation, which becomes critical from the organization and OEM’s (Original Equipment Manufacturer) perspective. Lack of timely information/ approval from the client can lead to disastrous results.
The spate of recalls in the past few years are a direct reflection of such omissions by the supply chain. These could have been avoided through a systematic and transparent 4M Change Management process.
Definitions (ISO 9000: 2015)
Change Control (Cl 3.3.10): Activities for control of the output after formal approval of its product configuration information.
Customers define Man, Machine, Material and Method (4M) specifications for each part and suppliers agree to adhere to the same while developing a new component. But in any industrial setup, change is bound to happen. In many cases, it is temporary but are we ready to change ourselves for that duration? If we can adapt, we will be able to fulfill the expectation of internal and external stakeholders. The majority of the customer complaints, rejection, warranty, recall attribute to ineffective 4M change (Royal Enfield: 4M change- Vehicle recall).
The key output is Product and to achieve it, we need to focus on the Inputs which are Man, Machine, Material, Method (preventive controls)
The temporary changes are generally kept under the wraps, although everyone in the organization knows about it (ISO 9001 / IATF 16949 Standard – clause 8.5.6).
Type of 4M changes:
- Approved skilled manpower changes (due to absenteeism, job change, occupied in other processes, Pandemic, Festivals).
- Whether the alternate manpower is equally competent and cost-effective?
- MSA (Measurement System Analysis) is one such method to monitor operator competency. Multiskilling is another way out.
- Approved measuring instruments like Gauge, Micrometer, CMM (Coordinate Measuring Machine), final testing equipment changes to the alternate measurement system
- Approved machine (Moulding, Press Shop etc.) changes to an alternate machine
- Whether process cost is same or not (Drilling machine change)
- Whether productivity, quality, cost, process capability is the same when changing the machine
- SPC study is one of the ways to monitor the process capability
- Approved material grade and make (Paint manufacturer, Approved supplier, mixing of scrap with virgin plastic material, high cost of raw material, non-availability of BOP-China Factor!) changes
- Storage condition of environment-sensitive material (Temperature, Humidity) changes
- Fool proofing method (Poka Yoke) changing to alternate measurement
How to effectively manage the 4M change?
- Define Procedure:
- A procedure should be prepared and documented.
- The intent should be to specify the possible alternate methods for inspection, testing, error proofing etc.
- The approval process has to be defined.
- The alternate methods should be based on Risk Analysis (FMEA).
- If customer approval has been taken, ‘the mechanism of how to do it is to be defined.
- Documentation: Once the procedure is documented;
- Existing process controls needs to be identified
- Wherever alternate methods can be applied has to be identified and documented.
- For each alternate method, like existing WI, additional work instructions need to be prepared for alternate methods (Temporary change).
- The intent is that ’Whenever there is the proposal for alternate change, the organization is ready with alternate methods’.
- Periodical review: As a part of effectiveness,
- proposed alternate methods need to be reviewed periodically.
- The intent is to check whether alternative methods are still relevant or need to be changed.
- A daily review of the effectiveness of alternative methods (if applied) should be done.
- It can be done by layered process audit (Audit by different levels in the organization-Plant Head to Quality inspector), daily review meeting or any other methodology defined by the organization.
- Customer approval:
- Depending upon agreement with the customer, their customer-specific requirement (CSR) and risk analysis, the customer approval may be needed before despatch of product.
- Traceability: During alternate method implementation,
- traceability of the product/service manufactured and despatched to the customer should be done.
- The objective is to ensure compliance (like Job setup- retention of first and last piece of production to check product quality)
- In case of any customer complaint, that lot can be tracked and suitable action can be taken.
- Restart verification (Original process):
- Once routine process controls are implemented again, verification of the process and product needs to be done for a defined timeframe (depending upon the criticality of the process) to ensure that existing controls are stable like Poka Yoke, process parameters, measuring system.
Why effective ‘Temporary Change process’ is important?
- Internal and external complaints can be minimized
- Low Cost of poor quality (COPQ)
- Enhancement in trust between organization and customer
- The customer becomes a partner in solving the problem of their supplier.
- No surprises in product quality.
Why ‘4M Change’ Process does not work?
- The organization does not trust their Customer!
- Customer does not trust their supplier!
- The additional cost of measurement and testing is generally not encouraged by management.
- The organization does not believe that alternative methods can result in defects.
- Ineffective Job setup process during 4M change
- Inadequate risk analysis like FMEA review with CFT (Cross-Functional Team)
- Ineffective internal communication process in the organization
Benefits to Top Management:
- Reputation and reliability with customers improve
- Enhancement in the employee empowerment
- Improvement in the transparency in the entire production process
- Cost of quality (COQ) reduces
– How often 4M changes are documented?
– How often while doing 4M changes, risk analysis (FMEA) is conducted with the cross-functional team?
– How often while doing 4M changes, the communication is done with the relevant internal and external stakeholders?
– How often while doing 4M changes, the changes are reviewed for their effectiveness as per the plan?
IATF 16949: 2016
ISO 9000: 2015
ISO 9001: 2015
This is the 136th article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.
In the words of Albert Einstein, “The important thing is never to stop questioning.” I invite you to ask anything about the above subject. Questions and answers are the lifeblood of learning, and we are all learning. I will answer all questions to the best of my ability and promise to keep personal information confidential.
Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.
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