Successful audits start with successful heat treat processes that are managed, controlled, and documented properly. The essentials are sometimes easy, maybe even obvious, and can usually be implemented quickly to kick-start your preparations for the next audit.
The appropriate production control and integrated quality management software can help you organize your processes (and the inherent individual operating steps) for easy/minimal 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, 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
- Review audit documents with the auditor, and collect additional information as needed.
- Record any audit findings.
- Outline path for
- Schedule audit follow-up if needed.
Of the audit types, let’s focus on finished 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 data organization.
The following six items are the essentials of successful service-based manufacturing/heat treating audits:
- Knowing what parts you are treating and to what specifications
- Creating and following a schedule, including real-time, dynamic part movement tracking throughout your facility and individual operator involvement on each step
- Building towards the highest quality and documenting all non-conformances and how they were addressed
- Managing work orders for specific job/part-processing requirements and focusing on how they will be reviewed during audits
- Knowing when and where errors occurred, and how to reduce errors in the future to ensure that all part-processing end products are correct
- Compiling all required 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 and should be supported by your production facility software.
Process Audit: This is an audit that confirms that all processes are performed correctly, efficiently, compliant with any applicable specs, 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 to completion for the timeframe of the audit period.
- Document issues or non-conformances in part-processing 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 or services are being audited, with associated materials and equipment.
- Create a schedule of production activities to include timeframes for materials or parts 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?
- Availability and organization of all documents is critical for a smooth audit.
Article provided by Bluestreak, MTI member since 2006. Bluestreak is a leader in Manufacturing Execution Systems including quality management systems and preventative maintenance. For more information on BlueStreak, visit www.go-bluestreak.com.