Learn how to cut your manufacturing quality audit time by 50% with this free eBook!

You’ll learn:

  • How to take control of your quality control audits
  • Actionable tips that will immediately improve your audits
  • The essentials of a solid audit process
  • The secret to avoiding business-halting audits
  • Best practices for process audits in manufacturing
  • How the right MES/QMS enables you to minimize audit times

Excerpt

Optimizing Your Manufacturing Audit Trail for 50% Reduction in External Audit Time

What if you could cut your audit times in half every time you needed to complete an audit? It would significantly reduce downtime, cut down on frustration, and make everyone more confident in the system.

If you’re still doing audits manually, you know what a mess they can be. Fighting through the audit trail to find the information you need, hunting down each piece of information to prove that you did what you said you did, and pulling it all together can be a real challenge.

We’re here to tell you that it doesn’t have to be that way. 

The right integrated quality management system (QMS) software, such as Bluestreak, can help. With paperless management of every step of the production pathway, Bluestreak captures everything you need in real time to create a fully documented audit trail. It makes external and internal audits go more smoothly and can reduce the time it takes to complete an audit by 50%.

The Cost of Downtime

Downtime is the single largest source of lost production time. When you need to shut down as part of the audit process, it can quickly get costly. The average manufacturer reports a loss of as much as $260,000 for each hour of downtime. Your downtime costs may be more or less, but there’s always a cost factor, including lost opportunity costs or labor expenses for workers who can’t move on to the next job until you’re done.

The process starts by automating your audit trail.

Dealing with Audits

We know that audits are no fun for anyone. Even if you’ve done everything right in creating parts or products, you have to provide the audit trail to prove it.

If you fail, you won’t make the customer happy. You might also lose certification or clients, as you have to go out of commission for weeks to remedy the situation.

Audits are all about traceability and creating an audit trail.

If you’re using a manual process to comply with audit requirements, you likely have file cabinets with paper documents that you’ll have to sort through. Lost and misplaced documents are common, and the time to track them down can add up quickly.

When you do find them, it’s not uncommon to find inaccurate or even conflicting information. Without a software system to require documentation at each step, it’s also not unusual to find that an operator did not record everything required. It might be something as simple as forgetting to completely fill out a form.

If you don’t have all your documentation available, it takes even more time to track information down. You may have to recreate documentation and then explain why the person conducting the audit should trust that it’s reliable.

The whole process can frustrate everybody working on it and cause customers to question whether you’re the right company to do business with.

How to Reduce Audit Time by 50%

The first step in reducing your audit times is to create a reliable audit trail with your software solution. By bringing every piece of documentation into a unified platform, you eliminate the information silos and manual mistakes that can haunt you.

It’s all about visibility and transparency. The right software program for service-based manufacturers will create the audit trail that you need. It will:

  • Eliminate information silos.
  • Qualify parts and personnel with appropriate verification and certification.
  • Show exactly where parts are on the production floor and what happened to them during production and testing.
  • Prevent parts from moving through the system until requirements at each stage for production and audit compliance are met.
  • Automate documentation and audit trail construction.

This takes the worry out of managing the audit trail.

But how do you cut your audit times by 50%? Use Bluestreak’s integrated quality management system and manufacturing execution system (Bluestreak QMS + MES). It’s an all-in-one solution that manages your entire production pathway, from order creation to finished product.

Bluestreak QMS + MES: Integrated Quality Management

Here are features in the Bluestreak QMS + MES that will make audits easier and improve your production quality and efficiency.

  • Flexible and customizable certifications
  • Control plan characteristics (even at the operation level)
  • Quickly add quality testing results
  • Role-based access control and restricted user viewing controls
  • Integrated control plans and process rules and instructions for operators
  • Supports/enables industrial additive manufacturing (AM/3D Printing) workflows
  • Built-in hyperlinks throughout the system to quickly get you the information that you need
  • Pre-loaded with commonly used quality characteristics and the capability to add as many as needed
  • Stored quality test result data (reported result, measured, converted, and rounded), creating full transparency of the data for verification of how test values were collected and reported
  • Automatically grouped product deliveries, by customer and delivery address, to assist the driver, and a single click on the delivery address to provide access to Google Maps
  • Centrally managed customer contact information, billing and shipping information, customer notes, part data, purchase orders, quotes, customer-specific media, etc.
  • For customers and managers, real-time notifications via email and/or text message of when parts have been picked up, put on a truck for delivery, or delivered to their dock and signed off (easily see who accepted the parts delivery and verify proof of delivery)
  • Manageable user-defined risk templates with “scorable” risk questions and answers to determine the overall risk in processing a particular part
  • Online help and training videos
  • ITAR/EAR user viewing controls

Non-conformances

  • Management of non-conformance parts and scrap
  • Advanced disposition control of scrap/parts
  • Issued non-conformances that automatically prevent parts from entering the next step in processing

CAPAs

  • Corrective actions/preventive actions (CAPAs) are automatically connected to future orders.
  • Quality managers know that CAPA instructions are viewed/acknowledged via electronic signatures.
  • You can view all work orders connected to a CAPA.
  • You can enforce the collecting of quality data from the shop floor during processing.

All these controls and features help create an extensible database, gather the information you need into one easy-to-access platform, and make audit trails easy to follow.

Work Orders

  • Spreadsheets can be added to a quote, if necessary, as a pricing worksheet.
  • There is work order part serial number control (validates part quantity).
  • You can make control plans non-editable or editable on work orders, depending upon requirements.
  • You can connect electronic and/or paper charts to work orders for every load in every operation.
  • You can attach quality-related media to work order processes, such as racking and loading instructions, instructional videos, pictures, diagrams, etc.
  • You can attach quoted or standard pricing to work order operations, based on any combination of part number, alloy/material, process (also quantities and part dimensions via grid/matrices).
  • Orders can contain any number of containers, part numbers, operation steps, certs, shippers, notes, media, loads, and quality control plan characteristics.
  • Bluestreak I intelliPlan™ leverages the power of mini-processes that can be embedded within other part processes (allows you to manage a single mini-process that can be used in hundreds of other processes).
  • When building a process on a work order for a new customer part, Bluestreak I intelliPlan™ filters the list of possible processes to select from based on required specifications, part information, and rules that you manage.

Production Floor

  • There are labor/indirect labor tracking functions.
  • There is BOM (bill of material) processing capability.
  • You can specify data collection requirements at each operation step, if necessary.
  • You can freeze processes to prevent changes to the process when used on a work order.
  • You can automate tracking of each part in a work order through all the required processing steps.
  • You can monitor all work in progress at every stage of processing, from contract review to shipment.
  • There’s a prioritized job list with entry date, promised date, requested date, and delivery performance date.
  • The parts in a single work order can be combined with parts from other work orders as needed, in any number of loads.
  • It gives the user a quick view of all the work within their work center queue (work is assigned to the work center automatically based on the current operation step specified on the work order; when an operation step is complete, the system routes the parts to the next step in processing).
  • It provides flexibility to track the splitting and combining of loads from one operation to another; if parts from a work order are split into multiple loads at operation step two, they automatically are recombined at operation step three, where the parts can be split again or simply processed as a single load (you can optimize the routing of work on the shop floor to meet unique processing requirements).
  • You can schedule jobs using the sequencer, calendar sequencer, or multi-equipment calendar.
  • You can alert operators with real-time quality notifications via Bluestreak I Global Communications Hub™.

Equipment Maintenance

  • There’s an effective preventive maintenance (PM) tool, allowing instant visualization of resourcing issues; you can schedule regular PM tasks or one-off maintenance orders.
  • It enables predictive maintenance by using the system’s run charts to identify non-random changes in the operating parameters of key process equipment.
  • You can track up/down time, labor hours, and repair costs.
  • Maintenance can be tied directly into production and scheduling.
  • Manage, plan, and schedule the maintenance and use of production equipment.
  • Automatically track load counts for specifications that have both time and load variables.
  • Maintenance orders are built using extremely flexible processes that support unlimited steps (and each step can be individually trackable), unlimited media (photos, drawings, schematics, PDFs, Word documents, spreadsheets, videos, instructions, or any electronic documents).
  • Operators can be prevented from using an out-of-service piece of equipment or one scheduled for maintenance.
  • It provides for lean manufacturing total productive maintenance by providing equipment operators instant feedback, allowing personnel to address negative trends before out-of-tolerance conditions occur.
  • You can enforce regularly scheduled equipment calibration checks by preventing operators from selecting equipment for quality tests unless a calibration check has been performed recently.

Reduce Your Anxiety Levels

Companies can get defensive about external audits. When somebody from the outside comes into your world and starts questioning everything you do, it can be disconcerting. It can feel like they are looking for problems even if you know that you’ve done everything the right way.

When everything you need is detailed, recorded, and available in one place, it helps avoid the dash to prepare for audits and can reduce the worry over having everything right (and readily available).

The best audit trails are ones where you can review them before an external audit without having to scramble to hunt everything down and hope that you can pull it all together in time.

Audits don’t have to be scary, especially if you’ve implemented the right systems and software to manage your audit trail. A bit of proactive care can make the result better for everyone.

The Bluestreak Solution to Reduce Audit Times

Bluestreak’s innovative solution enables businesses to conform to specification requirements every time, while automatically creating and maintaining a fully documented audit trail, including:

  • Managing specification documents
  • Knowing requirements
  • Having media
  • Automatically cross-referencing specifications, including processing, equipment, personnel, vendors, etc. 
  • Connecting and controlling everything about a specification, using a central, convenient, easy-to-manage tool

Bluestreak | Blue Docs

Bluestreak | BlueDocs™ maintains a detailed, time-stamped, and user-identified audit trail for each document that is compliant with certain accreditations, certifications, and compliance standards.

Paperless reporting follows the tracking, approvals, notification, and policy administration of quality documentation. It creates gatekeepers for approval and electronically tracks every interaction at every step. The Bluestreak QMS stores all test result data, so there is full transparency. This includes both the rest values themselves, as well as the process used for reporting.

Bluestreak | BlueDocs provides a variety of solutions to make managing your audit trail a more seamless process: 

  • Replace paper-based document control procedures.
  • Assign specifications for “personnel viewing,” aka ITAR/EAR.
  • Access, create, collaborate, approve, and change documents within a single system.
  • Version tracking, approvals, notifications, and policy administration of quality documentation.
  • Ensure that the most current revision of your quality manual and operating policies and procedures are centrally located and easily accessible from the shop floor.
  • Maintain a detailed, time-stamped, and user-identified audit trail for each document.
  • View what revision was “active and in force” for a previous work order, maintenance order, certification, non-conformance, CAPA, concern, quote, invoice, audit, etc.
  • Define a list of individuals who must approve the document.
  • Acknowledge any newly published documents, and electronically send the document before it is published.

Specification management allows you to support internal and customer specification, as well as the management of various industry specifications and credentials:

  • AIAG
  • API
  • AMS
  • AS 9100
  • ASME
  • ASTM
  • ISO 9001
  • MedAccred
  • NADCA
  • Nadcap
  • SAE
  • TS
  • ITAR
  • EAR

It creates a full-documented audit trail and cross-references specifications to everything that they impact. So, when a change is made in one area, the software will tell you how it will affect other areas. This updates your audit trail across the board in one step and alerts you to potential conflicts before they become problems.

Statistical Process Control

The statistical process control (SPC) feature in Bluestreak I SPC takes control plan characteristics to a higher level. Any control plan characteristic can be configured for SPC.

When test results are added, the SPC chart is updated in real time, allowing you to see and be notified at the time of test entry if there are any issues with your process. Again, this flags problems in real time that could otherwise be issues in the audit process.

SPC has extensible support for statistical rules to help you spot trends before your process is out of control. Upper and lower control limits are automatically calculated while you can determine if, when, and how you want to tighten your control limits.

Advanced Specifications Management

Bluestreak | Advanced Specifications Management gives you total control of all your specifications. It alerts you automatically to any discrepancies between quotes and work orders. This reduces potential audit issues before the production process even begins. It prevents process problems that lead to quality control issues and audit flags resulting from things such as:

  • Work order specifications that are replaced with revisions
  • Operators who attempt to process loads without documented training or certifications
  • Equipment being used that isn’t qualified (or qualifications have lapsed)
  • Vendors that aren’t qualified for specific jobs or have lapsed qualifications
  • Any changes to qualifications, certifications, instrument calibration, personnel, or survey requirements

Spec management prevents errors before they happen and can help you avoid bad audits in manufacturing. You can easily review any revision that was active and in force for work orders, maintenance orders, certifications, non-conformances, CAPAs, quotes, invoices, and audits.

Advanced specifications management lets you respond to auditors or customer conformance inquiries promptly. After the work order has been completed, the system has a built-in, robust audit trail documenting conformance to requirements and a process control matrix containing all supporting references.

Risk Analysis

Risk analysis can also be used system-wide in Bluestreak to provide accountability and audit-ability. Enforceable risk analysis built into your QMS helps remove the potential for human error during data entry and when reporting on certifications.

CAPAs

When CAPAs are needed, they are automatically connected to future orders. Quality managers can track CAPA instructions, which must be viewed and acknowledged by shop floor personnel before proceeding. It also enforces data collection from the shop floor during processing to maintain a complete audit trail.

Managing Test Results

As pieces and parts are produced, quality test data is stored and a complete audit trail is available for compliance. This includes everything from version tracking, approvals, and notifications to policy administration of quality documentation. Bluestreak’s detailed, time-stamped, and user-identified audit trail for each document can meet audit needs for required accreditations, certifications, and compliance standards.

Making the Switch to an Integrated Quality Management System

In manufacturing, it’s easy to get used to doing things the way that they’ve always been done. People can become reluctant to make changes. Even if they hate the way that things run right now, they justify it because they don’t see a better solution or take the time to find one.

If external audits are difficult now, continuing to manage them the way you currently do will just keep things at the status quo. With rising costs for raw materials and products, that won’t cut it anymore. To make progress, the manufacturing industry must adopt new technology.

Companies resist implementing software solutions that can help them for a variety of reasons. They may fear that the implementation will be too difficult or disruptive to the operations. They may worry that it will be overwhelming for the staff and might even cause good workers to quit. In today’s challenging labor market, it’s tough to replace employees.

Organizations may also worry that any gains from implementing new technology won’t outweigh the trouble. In other words, they aren’t convinced that the technology will truly make them more efficient or productive.

End-to-end control—from quoting to invoicing, maintenance, production tracking, and real-time customer portal access—creates a structured audit trail to track jobs throughout the production cycle. All your critical production documentation is available whenever you need it, with full visibility across all departments. Bluestreak provides total end-to-end control throughout the entire manufacturing lifecycle.

Ditch the Manual Process to Manage Audits

If you’re using a manual process now, you probably know how easy it is to falter in the audit trail. Audits will last longer and can shut down your business. If this sounds like something that you’ve been through, you’re not alone. Many manufacturers find themselves in this position and have to come to think of it as normal. 

It doesn’t have to be that way. Bluestreak can cut your audit times in half and make things much less complicated. The most common problem in external audits is failing to gather and present sufficient audit evidence. Bluestreak solves these problems by proactively recording every step in the production pathway to create a paperless audit trail so you have everything you need when it’s time for an audit.

There’s another serious reason for implementing a quality management system that goes well beyond just passing an external audit. When you’ve managed the entire end-to-end production pathway with Bluestreak, you’re raising the bar on quality. You’ll create better products, reduce non-conformances, and catch any errors much more quickly. This reduces scrap and waste.

It will reduce your risk and lower your overall cost of production while improving your output. It can translate directly to your bottom line and make your service-based manufacturing business more profitable. 

Without adding more equipment or employees, Bluestreak can significantly reduce your production costs, raise your quality, and make complying with audits simpler. Here are a few of its features:

Most companies that implement Bluestreak solutions cut production costs by 25%. 

It’s also about more than saving money or complying with audits. Using Bluestreak’s integrated quality management system to seamlessly integrate your floor operations ensures tight quality controls and flawless production. It improves the overall health of your business and helps you reach goals such as meeting all order specifications, increasing productivity, and making your company an attractive place for talented engineers to work.

All of that is on top of making your audits easier and less frightening.

Contact Bluestreak and Make Audits Easier

Contact Bluestreak today to automate your audit trail and cut your audit times by 50%.

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!