The best eQMS answer the question of how various audits add value, by preventing costly problems from occurring, and mitigating supplier business risk.
Let’s start by reviewing the types of audits, or checks, that your company may perform.
- You are likely performing internal process audits as part of your plan – do – check – act quality management system activities.
- Your company tracks the results of registrar audits of your internal management system.
- When a supplier is (re)qualifying to do business with your company, it’s common for them to complete a self-assessment. Your company’s stakeholders evaluate risk from financial stability, legal compliance, governance, location, quality, security and other business perspectives.
- Perhaps your company further assesses supplier risk with an onsite audit (or a remote audit during Covid). Onsite audits are common if you outsource manufacturing and white label finished products for sale, or if you have a high risk supplier.
- Your company may inspect shipments received from suppliers.
- Your company may test materials, semi-finished or finished goods received from suppliers
Working back from the question of value, we have at least 3 correlations we can make:
Are our internal processes being followed?
- An eQMS audit solution should accommodate at least the following:
- All processes are mapped to internal audits
- Internal audits are performed by different individuals on different dates
- It’s easy to determine which processes have been audited and which have not
- Internal and registrar audit results can be interpreted by anyone
- It’s easy to determine when processes haven’t been followed, through findings
- The reasons why processes have not been followed are discovered and captured in root cause analysis functionality
- All corrective actions are tracked to closure
- Internal and registrar audit results are summarized and improvement goals are set and assessed during management review meetings
Are we effectively determining supplier risk?
- An eQMS audit solution should support at least the following:
- Linking self-assessments, onsite audits, goods inspections and test results, to a single supplier
- Creating a supplier risk view for review at management review meetings and by other stakeholders
Do our processes adequately capture supplier risk?
- Do supplier self-assessments reflect actual supplier quality issues captured from shipping inspections and goods testing
Creating and managing audit or assessment questions and scoring results are standard in eQMS solutions these days.
Leading eQMS solutions like Origami, add value by easily correlating outcomes of audits, to give you and decision makers insight about supplier risk, your internal processes, in order to continually improve.