The previous article has presented areas of complaint management, revalidation tests and documentation review. In below we will focus on maintenance and scrap isolator area.
Maintenance area – Kingdom inside the Kingdom
During preparation for a OEM (original equipment manufacturer) customer audit in the maintenance area, first of all it’s necessary to verify that periodic maintenance have been planned for tooling and equipment owned by the customer. The development of such periodic reviews, from the point of view of production workstations, is the development of TPM’s level I and II.
The term TMP means Total Productive Maintenance and is one of the Lean Management methods relating to the cooperation between Production and Maintenance in the maintenance area of workstations on the production line.
TPM Level I refers to activities that are carried out by production operators to clean the machine elements which are accessible without the need to additionally disassemble the protective covers, verify the wear of the base plates, gauges, mechanical elements of Poka-Yoke’s or calibrators, and take readings from displays or gauges and compare their indications with technological requirements.
TPM Level II relates directly to the activities carried out by the maintenance services and consists in performing more comprehensive verifications that must be carried out outside the standard production cycle.
Picture 1. TPM II example – air leakage verification
Another thing that is crucial, is the review of service contracts under warranty support from tooling provider or constructor. This is especially important for tooling that is new to a given production location. During the verification, it’s also worth checking the telephone number provided in the contract. The same verification should be carried out when the maintenance activities are overseen by an external company for the current production phase or are performed on the second or third shift.
During a visit in this area, each customer representative (SQE, STA or another) may ask for a list of critical components from the point of view of price, delivery time or availability, so it’s important that such a list is properly prepared and managed. Additionally, this activity is expanded to define the minimum stock of components available in warehouse, below which a purchase order for a new part will be generated.
It’s also worth carrying out an internal inventory before the OEM client visit, in order to verify that the quantities in the system (or on the list) agree with their physical quantity.
Scrap isolator- “call” for non-conformity product management
Scrap isolator is an area with blocked sub-components, inter-operational products and products ready for shipment, for which non-compliance has been found during the incoming inspection (for sub-components) and controls carried out in the production process.
When preparing for the audit of this area, it’s worth remembering that the IATF requirements in section 8.7.1. “Control of nonconforming process – customer-specified process” don’t provide guidelines for the supervision of this area, but only inform that the organization must meet all customer requirements.
For customers using VDA requirements, details will be included in the VDA 6.3 process audit in point 6.2.4.
What then we should pay attention to? In the first place, if our organization has decided that this is a physically closed area, check whether this is actually respected, because often happens that it’s unsecured and a random unauthorized person has the opportunity to take such a sub-component or a finished product. One of the better solutions is to list the names of people or functions that have access to this area.
As in the case physical verification of the Maintenance spare parts, also when verifying the scrap isolator, the customer can physically check that the list of non-conform parts matches the physical quantities. Therefore, it’s good practice to carry out an internal inventory before and, if necessary, to take appropriate actions.
The last element worth paying attention to is the storage time of blocked parts. This is particularly important for finished products that undergo frequent modifications or sub-components with a specific expiry date (e.g. adhesives, lubricants or paints).
If such a situation is observed, the issue should be internally escalated together with appropriate actions (e.g. decision to scrap all such parts or intervention of central department).
You can download an automatic, editable Excel form for free on the Free Quality Tools
Document name: Check List – 50 activities to be verified before the customer’s visit – Excel form
