Quality control audits help you ensure that your processes are working effectively so you can minimize operational costs without sacrificing quality. As part of a robust quality control plan, you can reduce your material waste, scrap, and rework. You can also lower your cost per goods produced and limit unproductive downtime.
All this adds up to higher quality and an improved bottom line.
Proactive Quality Control Audits
When it comes to quality control, you can’t afford to wait until something goes wrong to do your analysis. By then, it may be too late to save projects and may lead to significant waste. Achieving better quality control audits requires proactive measures, including five key measures:
- System design
- System parameters
- Automated data processing
- Data visibility
- Automated audit trails
If you’re lacking in any of these areas, you’ll likely have a difficult time with your quality control audits. As you know, failing an audit can have significant repercussions.
In a manual process, the fear of failing quality control audits is compounded by concerns about being able to provide the necessary documentation to prove compliance. Documents can be lost, misfiled, or missing essential pieces of information needed to prove that the work was done correctly and within tolerances. If you’re still doing things manually, it’s time to automate and go paperless. That’s where Bluestreak’s integrated quality management system and manufacturing execution system (Bluestreak QMS + MES) comes in.
An ERP or MRP system won’t give you data visibility throughout the entire production process, from work order to finished product. Bluestreak integrates with nearly every ERP/MRP system on the market to provide the tracking that you need for quality control audits.
1. Quality Control Audits: System Design
Many quality audits uncover problems with the system design, not the process. Without precise—and automated—systems in place, things can fall through the cracks and cause problems down the line.
The Bluestreak QMS + MES eliminates information silos that lead to disconnected audit trails. Paperless data collection reduces errors and forces everything to be filled out before parts can move to the next production phase. Control plans are attached to each order to define specific quality and processing requirements that follow it through the entire production pathway.
2. Quality Control Audits: System Parameters
Bluestreak manages system parameters so you can be assured that the right information is in the hands of the right operator each time. Advanced specifications management supports industry specifications such as AIAG, API, AMS, AS, ASME, ASTM, ISO, MedAccred, NADCA, Nadcap, SAE, and TS, as well as any internal and Prime specifications.
Operator and equipment qualification, certification, and calibration records are created and maintained as part of the fully-documented audit trail.
Here’s one significant advantage of working with Bluestreak. The Advanced Specification Manager module automatically cross-references specifications to everything it impacts: processing, equipment, personnel, vendors, etc. Any discrepancies or conflicts will be flagged automatically.
3. Quality Control Audits: Automated Data Processing
Data processing is automated throughout the entire life cycle. As parts move through the process, each step is recorded to create the audit trail. All information is available in real time with Bluestreak. This includes management of:
- Work orders
- Production pathways
- Equipment maintenance
- Statistical process control
4. Quality Control Audits: Data Visibility
Data visibility is crucial to managing quality control. Using one central platform, you will be able to access real-time data and historical data at any time. You can even access the information remotely or give customers access to specific data for self-serve capabilities. Everything that impacts the production process and is necessary for a quality control audit is literally at your fingertips, including:
- Work orders and changes
Failure to adequately deal with and document CAPAs is one of the most common reasons that companies fail quality control audits. For service-based manufacturers in the life sciences and medical device industries, it’s the top reason that the FDA issues warning letters. Often, it’s not that they haven’t corrected the deficiencies; it’s that they haven’t adequately documented what they did. Creating a complete audit trail with transparency and data visibility is crucial.
5. Quality Control Audits: Automated Audit Trail
If you’ve done everything mentioned, your quality audits should go faster. You can reduce your downtime and lower everybody’s stress level. An automated audit trail makes the entire process go more smoothly and ensures effective quality control audit reports.
Bluestreak Creates Better Quality Control Audits
Real-time access to quality data and an automated audit trail are vital for better quality control audits.
Bluestreak’s Integrated QMS + MES 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’s an extensible software solution designed specifically for the service-based manufacturing industry and can capture any kind of production data in real time. Contact Bluestreak today and improve your quality control audits.
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!