ISO 9001:2015 Quality Management System – Evidence-Based Decision Making
Evidence-Based Decision Making in ISO 9001:2015 is one of the seven main principles of Quality Management Systems. So to have this as the main principle, you need to have evidence to use for making decisions. Therefore monitoring and measurement results give you this evidence to make decisions based on facts.
What is Evidence-Based Decision Making
Although it can be said that a lot of business decisions are made on gut feelings and perceptions, hard data and facts are difficult to ignore.
Evidence-Based Decision-Making is a process for making decisions about a process, activity, program, practice, or policy that is grounded in the best available evidence and is informed by experiential evidence from the field and relevant contextual evidence
Rationale based on 2.3.6.2 ISO 9001:2015
“Decision-making can be a complex process, and it always involves some uncertainty. Furthermore, it often involves multiple types and sources of inputs and their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Primarily facts, evidence, and data analysis lead to greater objectivity and confidence in decision making.”
Collection of Data and Evidence
You must gather data constantly and use it to make decisions. So do not let data sit on spreadsheets; use it to motivate action. Firstly, deciding your continuous improvement ideas, you will need to collect the data and evidence and examine it. Secondly, gathering the correct data is the key.
You need to put the collection of data first to develop your ISO 9001:2015 Quality Management System. Collect data and put it forward in a way that the shop floor staff understand. Management may use display boards with control charts, check sheets, action lists, and problem sheets. Then employees input the data themselves, enabling them to see whether the processes are working. Thus with the applicable and up-to-date data, you can make decisions quickly and thoroughly. Your ISO 9001:2015 Quality Management System will change from this:
This change reduces the number of internal quality non-conformances and customer complaints. In Addition, the company saves money, and profits rise, thereby assisting the company to avoid the dangers of bad decision-making.
Use SHEQ Software
SRM and many of our clients use Mango Compliance Software – Mango makes it easier to get ISO 9001:2015 certification. By using a SHEQ software system, it will make it easier to implement Evidence-Based Decision-Making processes. Additionally, all quality data can be input into Mango and extracted in various reports and graphs.
Why Evidenced-Based Decision Making is Sensible
- Firstly it increases the probability of getting the desired results
- Secondly, it helps you to understand the cause-and-effect evaluation
- So you will recognize possible unplanned results
- And it improves objectivity in decision making
Introducing the Process of Evidence-Based Decision Making.
Plan: to monitor the process performance. Identify the processes data for effective and efficient decision-making. Ensure that employees can collect and evaluate the data at set frequencies.
Do: Select and gather reliable data from different processes often
Check: and verify that the data is genuine, correct, and secure. Make sure that the data meets the goal.
Action: by analyzing the data and planning based on the available data with experience and awareness.
What are the critical outputs for Evidence-Based Decision Making
- Management Review minutes can contain an action plan for customer complaints and rejections.
- A strategy for internal rejection, scrap and rework repairs.
- Actions resulting from customer satisfaction surveys, competency mapping, and training need identification.
What are the benefits the company can achieve
In short, there will be an improved assessment of process performance and achievement of goals, thereby improving decision-making accuracy. So with adequate explanation and reliability of facts and evidence, it will enhance your capability of challenging any decision and justification. There will be an improvement in operational efficiency and effectiveness.
Challenges You Should Consider
- How often the source of data is reliable, also are the employees who are recording the data competent to do it.
- Is Top Management willing to base their decisions on an isolated incident or adequate sample size, additionally how often is the right data used for decision making.
Summary
Firstly the data that is collected must be correct and secondly relevant to your Quality Management System. Get the employees to add the data to the display boards, as it’s essential for the shop floor staff to view the data. So I’m sure you will agree that it is best to make decisions based on the right and reliable data.
SRM is ISO 9001: 2015: ISO 14001:2015 and ISO 45001:2018 certified. Contact our consultants today, and let us know if we can help you with the development and implementation of your Quality Management System.
Other related pages and articles:
https://srmc.co.za/iso-certifications/
https://srmc.co.za/iso-9001-in-90-minutes-series-1-clause-4-context-of-the-organisation/