Updated: Apr 14
Bluestreak Reading Time: 3 minutes
Successful audits start with a successful process. The essentials are easy, sometimes even obvious, and can be implemented quickly to kick-start your process before the next audit.
MES/QMS software can help you organize your manufacturing process for easy prep when an audit arises. Let’s go over the benefits and essential needs that are addressed when using a good program to prepare for successful audits.
First, however, the following elements must be identified and followed for audit success, from preparation to closeout.
Know the audit type.
Internal or external
Outline tasks, and collect required documents for the specific audit type.
Review audit documents with the auditor, and collect additional information as needed.
Record any audit findings.
Outline path for correction.
Schedule audit follow-up if needed.
Of the audit types, let’s focus on product and process audits and how the essentials of a successful audit are integrated for success in each one.
Before audit preparations can even begin, though, your production line specifics are critical items, immediately followed by impeccable organization.
The following six items are the essentials of successful manufacturing audits:
Knowing what you are manufacturing and to what specifications
Creating and following a schedule, including material movement and operator involvement
Building to the highest quality and documenting all non-conformance and how they were addressed
Managing work orders for specific orders and focused audits
Knowing when and where errors occurred, to ensure that all final products are correct
Compiling all documentation for auditor review
These are processes that should be in place no matter the timeline, before or during an audit. Preparing for a specific audit is easier with the assistance of these essentials.
Process Audit: This is an audit process that confirms that all processes are performed correctly, efficiently, and within their defined and established limits. Process audits look at operations, responses to issues, and overall procedures to see if they meet specifications.
When preparing for a process audit, addressing the following areas is vital.
Know the answers to these questions: which equipment is used in the specific process being audited? When is planned maintenance for the equipment? When was the last maintenance and repair dates, including all parts replaced or repairs made?
Compile all calibration records.
Provide documentation to support any issues experienced with the equipment, production staff using the equipment, and how these issues were addressed.
Have work order management details outlining which orders were processed through for the timeframe of the audit period.
Document issues or non-conformances in products that resulted from the equipment included in the audit.
Ensure that all documentation is organized and complete, including any financials, personnel, and training.
If requested by the auditor, additional details may be required.
Product Audit: Product audits take a deep dive into the products and services offered, to ensure compliance with regulatory standards and performance specifications as set forth by the regulatory agency, company quality standards, or customer needs.
Clearly outline which products are being audited, with associated materials and equipment.
Create a schedule of production activities to include timeframes for materials to arrive and each step of production, testing, quality checks, and final acceptance for shipping to clients.
Compile documentation of all non-conformances discovered and all failed testing or quality checks.
Know the answers to these questions: how are quality issues addressed? Are products re-worked or scrapped? What is being done to prevent the same issue from happening again? Which clients have received these products, and how does the product meet the work order specifics? As problems are identified, how are they tracked? How is final acceptance determined and documented?
Organization of all documents is critical for a smooth audit.
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 helps build better relationships with your customers, contact us for a free demo today!