What Sets Deviation Permits Apart from Concessions in Manufacturing

You will see the biggest difference is timing and purpose. In manufacturing, a deviation permit concession lets you plan for unusual products before making them. A concession is used when problems are found after products are made. This difference is important because it affects how you control quality and follow rules. Think about finding a design problem before making a batch. Using a deviation permit concession helps you follow the rules and save money.

Definitions

Deviation Permit

A deviation permit is used when a product does not meet the original rules. You ask for this before you start making the product. You need permission to change something in the design or process. The permit lets you make a small number of products with these changes. ISO 9000:2005 says a deviation permit allows you to change the rules before making the product. You must follow strict steps and write down everything you do.

A deviation permit helps you keep quality high. Every change is checked and approved before you start making things.

• You fill out a supplier deviation request form to show your change.

• You get approval from the right people at your company.

• You keep records to show you followed the rules.

• You use the deviation permit for a set time or amount.

Concession

A concession is used after you find a problem with a product that is already made. The product does not meet the rules, but you still want to use or deliver it. You must show the product is safe and works as needed. There are steps you must follow to get a concession:

1. You check the risk to make sure the product is safe and meets the rules.

2. You fix the problem for now and plan how to fix it for good.

3. You keep records of everything, like reports and risk checks.

4. You set an end date for the concession so the problem does not last.

5. You talk to your customer and get their agreement before you deliver.

Standards Reference

You must follow rules like ISO 9001 when you use a deviation permit or concession. These rules help keep products safe and high-quality. ISO 9001 says you must write down every change and get approval before shipping. You need forms and reports to track each deviation permit and concession. This helps stop mistakes and keeps customers updated.

Deviation Permit Concession: Key Differences

Timing

A deviation permit concession is used before making a product. This helps you plan for changes early. You know about the problem before you start. You can ask to change the design or process. You use deviation permits when you see a problem in drawings before making anything. In places like car or airplane factories, you may need a deviation permit concession for "pass through" characteristics. These are things not shown or not matching the drawing.

A concession is used after the product is made. You find a problem when you check or test the product. You ask for a concession if you still want to use or send the product. The product does not meet all the rules. Timing is important because it changes how you handle risks and costs.

Tip: If you find a problem early, you can use a deviation permit concession. This saves materials and time.

Approval

You need approval for both deviation permits and concessions. The steps are not the same. For a deviation permit concession, you get approval from your company. Sometimes you also need your customer’s approval before making the product. You fill out a form and explain why you need the change. The right people look at your request and decide if you can go ahead.

For a concession, you ask for approval after finding a problem. You must show the product is safe and works well. You talk to your customer and get their agreement before sending the product. Groups like the FDA and EMA want you to handle approvals carefully. They want you to check every change and make sure it does not hurt safety or quality.

Impact

A deviation permit concession usually has a smaller impact. You plan for the change and only use it for a few products or a short time. You keep quality high and avoid surprises. Deviation permits help stop bigger problems later.

A concession can have a bigger impact. The product is already made, so you must decide if you can use it or fix it. You may need to talk to your customer and explain the risks. If you do not handle concessions well, you can lose trust and have safety problems.

Documentation

You must write down every step for both deviation permits and concessions. Good records help you know what happened and why. If you do not write down a deviation permit concession, you can lose track of changes and hurt product safety. You need to:

1. Find the product that does not meet the rules.

2. Look at the problem.

3. Ask for a deviation permit concession or concession.

4. Write details about the problem and what you want to do.

5. Talk to your customer.

6. Get your customer’s review and approval.

7. Write down the decision.

8. Do the approved actions.

Digital tools make record keeping easier. You can use software to collect and share information and follow rules. These tools help you manage deviation permits and concessions, lower mistakes, and show you care about quality.

• Good records keep your products safe.

• You can track every change and action.

• You avoid risks and follow the rules.

Note: If you do not write down a deviation permit concession, you can lose track of your product and have big problems with quality and safety.

Commonalities

Controlled Process

You have to follow a controlled process for both deviation permits and concessions. You cannot skip steps or make changes without getting approval first. You need to keep records and get the right people to sign off. Both processes help keep products safe and meet quality standards.

Here is a table that shows how both processes work:

Both need formal approval and careful records. You must write down every step and keep track of what you do. You cannot deliver products unless you follow these rules. This helps you avoid mistakes and keeps your customers happy.

Tip: Always use a checklist to make sure you finish every step. This helps you stay organized and not miss anything important.

Authorized Personnel

You need special people to manage deviation permits and concessions. You cannot approve changes by yourself. Your company picks people who know the rules and can check for risks. These people look at your request and decide if you can go ahead.

You may need to talk to your customer for approval. Sometimes, only certain managers or engineers can sign off. You must know who can approve before you start. This keeps your process fair and safe.

• Only trained staff can approve changes.

• You must follow your company’s rules for who can sign.

• You need to check with your customer if the change affects them.

When you work with authorized personnel, you protect your company and your customer. You show you care about quality and safety. You also build trust by following the right steps every time.

Deviation Management and Customer Concession

Compliance

You have to follow strict rules for deviation management and customer concession. These rules help you meet standards like FDA and ISO 9001. If you do not follow the rules, you might get fines or have to recall products. Deviation management helps you find problems early and fix them fast. This keeps your products safe and helps people trust your company. When you ask for a concession, you show your customer you care about safety and quality. You need to write down every step and get approval before you go ahead.

Tip: Always check your process with the newest guidelines. This helps you avoid mistakes and keeps you following the rules.

Customer Communication

You need to talk clearly when you handle customer concession. If you send a concession request, you must explain the problem and how you will fix it. Customers want updates and honest answers. You should share timelines and tell them about any delays. If you change prices or terms, you must tell your customer right away. Giving regular updates helps build trust and loyalty.

• Give updates and timelines for each concession request.

• Be open about prices and contract terms.

• Use supplier web pages or meetings to share news.

• Tell your customer about good changes.

When you handle customer concession well, your customer feels important. You stop confusion and make your relationship stronger.

Risk Management

You face risks when you use deviation management or send a concession request. You must look for problems that could hurt product quality or safety. Deviation management helps you find risks early and fix them quickly. You use checklists and reports to track every step. If you do not handle customer concession well, you can lose trust or pay extra costs.

You see fewer defects when you use good deviation management. You save money and keep your products safe. You also stop confusion about waivers and concessions. Clear contracts and open talks help you manage risks and keep things fair.

Note: Always check your deviation management steps. This helps you find hidden risks and make your process better.

• You use deviation permits to plan changes before making products.

• You ask for concessions after you find problems in finished items.

• You keep quality good by following steps and getting approvals.

• You build trust with customers by being honest and clear.

Using these ideas helps you follow rules and lower risks. You keep your products and your company safe by handling deviations and concessions the right way.

FAQ

What is a deviation authorization and when do you need it?

You need deviation authorization before making a product that will not meet the rules. You fill out a request to get approval first. This helps you control products that do not meet requirements. It also helps keep quality high. You use integrated deviation management to watch every change.

How does concession authorization work for nonconforming products?

You use concession authorization after finding a product that does not meet the rules. You must show the product is safe and meets the requirements. You need your customer’s approval before shipping these materials. You also have to follow rules for marking materials sent under concession.

Who gives customer authorization for deviation or concession?

Customer authorization comes from the customer’s quality or engineering team. You must explain the change or problem with the product. You get written approval before sending these materials. Authorization keeps your process safe and builds trust.

Why do you need to identify materials shipped under concession?

You must mark materials sent under concession so everyone knows about them. This helps you track these products and avoid mistakes. You need customer approval for each shipment. Good records help you follow the rules and keep products safe.

What is integrated deviation management and how does it help?

Integrated deviation management lets you track every deviation and concession approval. You use software to record each approval from your company and customer. This system helps you manage products and materials that do not meet the rules. It also keeps your process organized.

See Also

Exploring Shrinkage and Machining Allowances in Casting

Decoding PPM Within IATF 16949 Certification Standards

The Importance of SMED in Modern Lean Manufacturing

Understanding PPAP: Essential for Quality in Manufacturing

An Overview of Jigs and Fixtures in Manufacturing

About Hunan Puka

Established in 2016 and based in Hunan, China, with a liaison point in Berlin, we are a Tier 2 supplier for the automobile industry. We specialize in the production of customized aluminum die-casting parts designed for machines with a closing force ranging from 280 to 1250 tons, with subsequent manufacturing process CNC machining and surface treatment. Our commitment to quality is reflected in our accredited quality management system, certified by ISO9001:2015 and IATF16949:2016 standards.