This Clause is designed to provide a method to prevent damage or deterioration (i.e., preserving and segregating product). It includes appropriate storage to secure product or parts with receipt and dispatch methods. Control of packaging, packing and labeling processes is required. It links to Clause 4.3, 4.7, 4.8, 4.9 and 4.10 and requires protection of product throughout the production process.
Clause 4.15 is brief and often not adequately addressed. To better understand each section and its requirements selected guidance from ISO 9004-1 and ISO 9000-2 is provided.
Guidelines: ISO 9004-1
Section 16 Post-Production Activities
16.1 Storage: Appropriate storage methods should be specified to ensure shelf life and to avoid deterioration. Storage conditions and the conditions of product in stock should be checked at appropriate intervals for compliance with specified requirements and to detect any loss, damage or deterioration of product.
Section 10 Quality of Processes
10.1.5: The appropriate methods of cleaning and preserving, and the details of packing, including moisture elimination, cushioning, blocking and crating should be established and maintained in documented procedures.
10.4 Handling: The handling of product requires proper planning, control and a documented system for incoming, in-process and final product. This applies not only during delivery but up to the time of being put to use. The methods of handling product should provide for the correct selection and use of suitable pallets, containers, conveyors and vehicles to prevent damage or deterioration due to vibration, shock abrasion, corrosion, temperature or any other conditions occurring during the production or delivery process.
ISO 9000-2 Guidance will be included as a reference with selected 4.15 requirements.
Clause 4.15 Handling, Storage, Packaging, Preservation and Delivery includes:
"The supplier shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product."
ISO 9000-2 Guidance "The supplier's system for handling, storage, packaging, preservation and delivery of materials should provide proper planning, control and documentation. This includes in-process materials and finished product."
The scope of 4.15 requires procedures for each section. Begin by the processes your company uses from receiving through delivery of product identifying (use a flow diagram as shown in Chart I). Write a single procedure to document 4.15 requirements and how they are met. Identify where work instructions are necessary to support 4.15 procedures. Develop and implement each work instruction.
"The supplier shall provide methods of handling product that prevent damage or deterioration."
ISO 9000-2 Guidance
"The supplier's method for handling materials should consider providing transportation units (such as pallets, containers, conveyors, vessels, tanks, pipelines and vehicles) so that damage, deterioration or contamination (due to vibration, shock, abrasion, corrosion, temperature vari-ation, radiation or any other con-ditions occurring during handling or storage) may be prevented. Maintenance of handling equipment is another factor to be considered."
Identify how you presently handle product. Do you use forklifts, gaylords, conveyors, etc.? If so, what training, maintenance or other knowledge/certification is required to safely do so? Consider safety of people as well as product. Look at your flow chart and identify where handling occurred throughout the process. Consider developing specific work instructions for each handling situation. Be sure that all product is marked indicating its approval for use. The handler will visually verify this approval prior to moving the product to its intended location.
"The supplier shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated."
ISO 9000-2 Guidance
"The supplier should plan for suitable storage facilities, considering not only physical security but also environmental conditions (e.g., temperature and humidity).
For many companies inventory stores or warehouse stores are tightly controlled by people and computer systems. Work orders, bills of material or part requisitions are used to provide authorized dispatch.
Receiving work instructions direct the receiver about marking or labeling product for storage. Warehouse handlers move product to its aisle, row or bin location. These data are entered into the manual or computerized system.
Some companies are moving toward bar coding to speed this process and eliminate paperwork. Systems in place prevent individuals from entering the warehouse or stores and taking items without proper authorization. This process requires knowing the content of stores at all times. Periodic inventory/cycle counts help assure that items on hand are in good condition for use. In practice, many small items are not controlled in stores. For each item both receiving and quality assure use prior to storage. It is the user's responsibility to visually inspect the bolt, screw, etc. prior to use.
Environmental conditions are not always adequately addressed. Climate conditions may require heat, air conditioning or humidity control. It is necessary to identify product/items requiring special storage environmental conditions and provide for such conditions.
"In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals."
ISO 9000-2 Guidance
"It may be appropriate to check periodically items in storage to detect possible deterioration. The methods for marking and labeling should give legible, durable information in accordance with the specifications. Consideration may need to be given to administrative procedures for expiration dates, and stock rotation and lot segregation."
You are probably conducting periodic manual inventory counts and matching the results to your automated system or manual card system. Identify use of FIFO, LIFO or other inventory methods to help your warehouse manager retrieve items for issue. Upon receipt, shelf-life items should be adequately identified.
The frequency of inventory assessment should be documented in your procedure and depends upon your warehouse (i.e., building size, number of stock turns, climate control systems and access to warehouse).
The following example was a learning situation. A customer requested the manufacturer to apply a Velcro tab to each part. The customer supplied the tabs in large roll form. Each tab was sticky (adhesive) on one side. Without realizing it, the tabs on the roll were not environmentally shipped or controlled upon receipt. It was summer and very hot in the warehouse. Upon application, each tab passed inspection. However, within a few days the tabs began to lift (going back to the memory position on the roll). If the customer and user had placed the rolls in a climate-controlled, air-conditioned area, the memory would not have been an issue. In fact the heat helped to cure the tab memory.
"The supplier shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.
ISO 9000-2 Guidance
"The supplier's packaging procedures, materials, packaging and labeling designs should provide appropriate protection against damage, deterioration or contamination during storage, transportation or any later period until the supplier's responsibility ceases. The various forms of storage and the types of transportation that can be encountered should be considered. The packaging should provide a clear description of the contents or ingredients where regulations or the contract specify. Provisions should be defined for checking the effectiveness of the packaging."
Develop work instructions including packing (i.e., how items are packaged, the position and number of items per container). Packaging is the type of material used such as cardboard box, wood crate, cylinder, shrink-wrapped and so on. This requirement is often defined during contract review based on customer requirements. Work instructions direct personnel to:
- Reference the work order, traveler or packaging directions supplied by the customer.
- Select or build the appropriate container.
- Select specific packing directions, papers, inserts like certificates of conformity or warranty information.
- Select a specific label used to identify delivery information. Labels may be provided by the customer or produced by in-house labeling equipment.
Product may be packaged to be shipped directly to the end user. This process requires the correct label and packaging markings as does product shipped out of the country. If you export, be sure to comply with the specific country laws.
Packing and packaging training includes the knowledge and skills required to ensure product remains in its original condition by protecting it from damage or deterioration during storage and transportation. Document training using your training record process.
"The supplier shall apply appropriate methods for preservation and segregation of product when the product is under the suppliers' control."
Preservation is a consideration from receipt through production. Work instructions and/or training provide specific preservation steps for each process, if required. Application of coatings, or other materials should be identified in your method, traveler or work order. For production practices special preservation could be in the form of handling product with gloves only, clean room operations and handling temperature- or moisture-sensitive product. Consider the stacking height and weight of boxes. Stacking many heavy boxes on a skid does not preserve the product in the bottom box.
The second part of 4.15.5 addresses segregation of product. We are talking about approved product for shipment. Nonconforming product follows 4.13 requirements. If you deal with flammable materials or toxic materials, it is mandatory you positively identify their containers.
Your work instruction should identify how warehouse storage preserves finished product and where product ready for shipment is staged (preserved) prior to loading. It is a good idea to sign this area.
"The supplier shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination."
Be sure your trucking or other delivery vendors are listed on your approved vendor/supplier list. It is necessary to show that final inspection requirements are completed with objective evidence. Take this requirement one step further and define how you ensure all relevant specified (inspection) requirements have been completed. By doing so, you can only release approved product that meets specified requirements. Delivery processes capture data including ship date to be used to measure on-time delivery.
If the customer requires protection extended to destination, purchasing becomes involved making specific legal arrangements to meet contract requirements. This requirement is identified during contract review.
Clause 4.15 is designed to protect product and people through all stages of production. Flow diagram and document your present practices and compare them to each of the 4.15 requirements. You might find that your practices are in place and only need documentation. Implement mandatory training for handling, inventory systems, work instructions for packing, packaging and preservation. By doing so, you will continuously improve your operation as well as meet ISO requirements.