Table of Contents
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PFMEAs typically look something like this...
Impact * Legislation * Frequency * Controls = Priority (RPN) (Such as 10 * 3* 4 * 1 = 120)
The severity of an impact defines its significance (not the RPN). The severity of impact is affected by:
- Existence of a pollutant (toxic and volume) – or – Use of large volumes of resources
- Method for pollutant to migrate to the environment – or – Is the resource being depleted
- The existence of receptors that can be impacted by the pollutant – or – The effect of the resource depletion
- Geographic spread (local impact or global)
ISO 14001:2015 – aspects must be considered using a lifecycle philosophy, Product is an important part of the environmental system. What must be considered:
- Raw materials selection and energy usage
- On site activities (includes any outsourced activities or materials)
- Product impact (resource depletion, pollution, waste,)
- Product disposal
FEATURED QUALITY TOOL – KAIZEN
What is Kaizen?
Kaizen (改善 in Japanese) meaning gradual, orderly, continuous improvement. Kaizen business strategies involve everyone in an organization working together to make improvements ‘without significant capital investments’
Two Elements of Kaizen
There are two elements that make up Kaizen; improvement/change for the better and ongoing/continuity. Lacking one of these elements would not be considered Kaizen. For instance, the expression of “business as usual” contains the element of continuity without improvement. On the other hand, the expression of “breakthrough” contains the element of change or improvement without continuity. Kaizen should contain both elements.
Maintenance, Innovation, and Kaizen
Three actions should happen simultaneously within any organizations: Maintenance, Innovation, and Kaizen. By maintenance, we refer to maintaining the current status, the procedures are set and the standards are implemented. People in the lower level of organization mostly do that, they maintain their standards.
By Innovation, we refer to breakthrough activities initiated by top management, buying new machines, new equipment, developing new markets, directing R&D, change of strategy etc.
In the middle there is Kaizen, small steps but continuing improvement. Kaizen should be implemented by the lower/middle management and the workers, with the encouragement and direction of the top. Top management responsibility is to cultivate a Kaizen working cultures within the organization.
ISO 9001:2015, ISO 14001, and ISO 45001:2018 Criteria 6.2
Objectives & Planning To Achieve Them
What is required?
- Function/level or process based (considering requirements, aspects and hazards as applicable to each standard)
- Consistent with policy statement
- Consider requirements and risk (and for ISO 45001 involve workers)
- Periodically updated
- What will be done
- Resources required
- When will actions occur
- How will results be measured
- Integration into business processes
What is a Function?
A department; such as:
- Sales Department
- Quality Department
- H&S Department
- Marketing Department
- Production planning
- Operations (machine shop, paint shop, weld shop, etc.)
- Design Department
What is a Process?
- Defining strategy
- Order receipt
- Raising a purchase order
- Reviewing an order
- Supplier evaluation
- Placing a purchase order
- Receiving a part
Confusion between ISO 9001:2015 objectives (6.2) and monitoring and measurement (9.1)
Monitoring and measurement is performed on the outcomes of a system (lag indicators).
Objectives focus on changing how functions or process are performed to archive a desired
change in outcomes.
Objectives cannot be set at the outcome level, they must be at either process or functional level.
Unacceptable objective example
On time delivery – (why) on time delivery is neither a process or a function, it is a lag indictor.
To change the lag indicator you must change how a function operates, or how a process is performed.
For on time delivery the following processes may contribute to non achievement of the desired outcome:
- Sales (was achievable delivery promise made?)
- Purchasing (are materials being purchased on time?)
- Customer (is customer making changes to requirements?)
- Production planning (is planning effective?)
- Production (is production meeting expected TPY?)