Using Our ISO 9000 Access Database
The ISO9000Resources.com Database was designed for smaller manufacturing companies that do not have a lot of resources available to manage ISO required records. The database was designed require the absolute minimum resources to maintain ISO compliance. My goal was to be able to start and finish a level III ECR/ECO in less than 5 minutes (excluding documentation changes). Since level III ECOs are the bulk of the documentation changes, this feature can save quality and engineering managers a lot of time.
Here are the basic principals used in the database.
Engineering Change Requests (ECR)
Every customer related, product related or service related problem is entered onto the ECR system.
- Anyone in the company can initiate an ECR. Engineering Change Requests can be enter by the initiator or by the database manager. You may use a paper system to generate the original information about the problem.
- The ECR system is like a pending "TO DO" list that is managed by the assigned ECR manager.
The ERC manager has 2 basic options:
- Investigate the issue and dismiss the problem if it has no merit. Justify this decision in the ECR system.
- Investigate the issue and start an ECO for the problem. Assign resources and a priority.
Engineering Change Orders (ECO)
Every Engineering Change Order is triggered from an ECR.
Engineering Change Orders should be tied to a product line. This make the reports much more useful.
One ECO can affect many different documents. Per ISO, every document change should have a revision change. The document section of the ECO is designed to manage the revision change process.
Engineering Change Orders have varying level. The ECO manager assigns the level based on the scope of the problem. Setting the level will automatically select (check) the required approval signatures. There are 3 levels of ECOs.
- Level III (about 80% of ECOs). They include typographical errors and corrections. Although they still require an ECO to comply with ISO, they require the minimum level of approval and should take less than 5 minute from beginning to end.
- Level II (about 18% of ECOs) require addition approvals so there is additional time and expense. A typical level II ECO will include changes that require modification of the existing inventory.
- Level I ECOs are very rare and very expensive. This includes a product recalls and other major safely issues. The level I ECO must go all the way to the top of the organization for a final approval.
Almost all ECOs are permanent. A temporary ECO is the same as what most companies call a "Temporary Deviation Notice". A TDN allows a business to ship product that does not fully meet specification per the existing documentation. This can happen when there is a problem that could take months to resolve like when an injected molded part needs a redesign but product will be shipped during this period.
The implementation portion of the ECO is designed to show the affect of the change on each area of the company. Based on the written ECO procedure and verbiage on the ECO, each area will have a different process for managing the change. This area is also helpful to make the ECO administrator think about all the areas that could be affected by the change including inventory, manuals and the service department. Here are a few examples:
- Production: Destroy the existing documentation in production and replace it with new docs. Train the personnel on the new procedure or process.
- Inventory: ECO should designate use as is, rework or scrap for any part that changes revision level for each area. including parts on order, WIP and finished goods.
The "approved products" section of the ECO form is used for CSA,UL, and other safety approved products. This section is only used for these products. If you have an approved product, this areas is used to trigger and notify the appropriate external organization of the pending change.
The Status level at the bottom of the ECO serves 2 functions. It track progress on the change and also helps remind personnel that they must attend to every detail of the ECO. The button at the bottom of the Status block will check all the blocks and enter the current date into the closed date. This can save some time on quick level III ECOs.
- If you do not have a copy of Microsoft Access, Here is the runtime version. Click here to download. This is a zipped file but it is still about 11 meg. Just unzip it and then execute the setup.exe to install the runtime version as part of the free access database.