When you fail an external quality audit, bad things can happen. You might lose customers. You might have to shut down for an extended period to retool, retrain, or diagnose quality issues. You might have to delay fulfilling future orders or even turn business away.
It’s nearly impossible to create the audit trail that you need to satisfy an audit if you don’t have a system set up that tracks what you need. If you’re still doing this on paper and spreadsheets, you’re asking for trouble.
There are two common reasons that external quality audits fail:
- Human error
- Inability to produce the data to support what you’ve done
Ensuring that you have a solid manufacturing quality audit process in place to avoid this scenario is vital to the success of your business. Creating a paperless, automated audit trail is crucial.
Documentation That External Auditors Might Request
Every document and record that is part of the production process and might affect the quality of parts and products needs to be captured and retained. While external audits might focus on different areas depending on the part, product, or customer, there are certain documents that you should have available.
Management Commitment to Quality Management
One area that will be examined is the alignment between what management says it does (or requires) and what’s actually being done. This might include such areas as:
- Risk assessment
- Qualification of equipment and personnel
- Maintenance and calibration
- Dealing with nonconformance
- Consistent recordkeeping
The Essentials of a Solid Manufacturing Quality Audit Process
There are so many forms and paperwork. Each step must be documented. Every piece must be filled out properly and completely. If there’s a problem, not only do you have to resolve the issue, but you also have to document what happened and what you did to correct it to avoid incidents. Then, you need a filing system that allows for quick retrieval when it’s time for your external quality audit. On top of all that, you must hope that you can find what you need and that everybody did their job filling everything out at every step of the way.
If this sounds like your current process, there’s an easier method.
To ensure that you’ve covered your bases with the essentials, you should have a quality management system and manufacturing execution system (QMS + MES) that creates a paperless, automated audit trail.
Bluestreak’s Integrated Quality Management System ties quality control and quality assurance directly to individual work centers and processing steps on the production floor, all in one inclusive database, with no separate silos of disjointed data. It allows a paperless process that contains every piece of information that you need to pass an external quality audit. It’s flexible enough to record any piece of data that you need, and it automatically creates an audit trail for fast retrieval upon demand.
Audits can be time-consuming and often include lengthy downtime. Bluestreak can reduce audit times by up to 50%.
Managing External Quality Audits
External quality audits are vital for satisfying customers, but they also can provide a blueprint for improvements. They are part of a continuous improvement program that should be part of every service-based manufacturer’s process. The more efficient and productive your systems are, the more you can reduce your cost per part and your overall manufacturing costs.
When it comes down to it, internal or external audits come down to having the basics in place for every step of your production process.
- Lay out what you’re going to do.
- Do it.
- Take appropriate actions when issues arise.
- Prove that you’ve done it.
It all works fine if you have a system and processes in place to capture all the relevant data to create an audit trail that will satisfy an external quality audit. Bluestreak has been designed specifically for the service-based manufacturing industry to capture data in real time and generate the audit trail you need.
Don’t take a chance with your manufacturing quality audits. Ditch the paper and the problems by implementing Bluestreak’s extensible QMS + MES system.
If you’re tired of business being halted for lengthy audit processes and want to see how automation not only cuts your audit times in half but also helps build better relationships with your customers, contact us for a free demo today!