3.1 Quality management system
Essity requires that suppliers implement and follow a quality management system conforming to all requirements in the current ISO 9001 standard. In general, the preferred level is ISO 9001 certification. For certain medical devices, the certification standard ISO 13485 is required.
3.2 Risk management
Supplier shall conduct a risk assessment to evaluate the impact on goods supplied to Essity each time a change is introduced into its production process, including, without limitation, a contamination risk assessment. In making such assessment, supplier shall take into account the factors specified in Annex A1. All risk assessments shall be documented and kept updated.
The supplier organization shall have a written contingency plan in place, including production back-up solutions, which may be implemented as necessary in the event of short supply of raw materials, production disruption and so on in order to avoid or limit detrimental consequences for Essity.
3.3 Site standards (infrastructure)
Essity expects that supplying sites are suitably designed, constructed and maintained so as to minimize the risk of goods contamination, are in compliance with all relevant legislation and operate in a safe and secure environment.
The manufacturing process flow shall be organized to allow sufficient working space and storage capacity with adequate employee facilities (including rest areas, toilets, lockers and changing areas) provided and maintained in a clean and hygienic condition.
- Products, services, process and quality assurance in the supplier’s field of activity
- Supplier’s own market status
- Patents and other intellectual property in the supplier’s field of activity
- Products, services and markets in the field where Essity operates
3.5 Documentation requirementsRelevant documented information shall be kept available for evaluation by Essity for a period of no less than five years or, if longer, for the period stated in applicable legislation and/or regulations (e.g. for chain of custody, medical devices, cosmetics regulation, REACH regulation). At a minimum, such information should include:
- Specifications of the goods delivered
- Quality control data/certificates of analysis to prove conformity of the goods delivered
- Traceability documentation of raw materials/components used for production of the goods delivered
3.6 Communication and interaction with Essity
Suppliers shall document their processes for interaction with Essity.
Each supplier shall appoint a qualified individual to serve as the Essity coordinator for agreements, orders, customer satisfaction and feedback, claims, quality issues, queries and corrective actions.
Supplier shall also appoint a technical contact person who shall be responsible for ongoing technical activities and shall be authorized to communicate and make decisions directly in consultation with their Essity counterpart. The roles of the technical contact person and Essity coordinator can be filled by the same individual if desired. He or she should be able to communicate well in English and be able to travel to Essity facilities. Local communication between the supplier and Essity may be in the local language.
Furthermore, supplier shall identify a contact person or persons for product safety and environmental information.
The content of agreements with and feedback from Essity shall be communicated by supplier to relevant functions within its organization.
Upon request, the supplier shall communicate the plans for and status of activities performed in cooperation with or on behalf of Essity.
Suppliers are expected to proactively present new developments.
Essity expects its suppliers to respond to any queries within a reasonable period of time. Suppliers shall ensure that relevant persons in their organization receive information about and understand the interactions between their own development activities and those of Essity.
All goods shall be defined by an agreed set of specifications or technical data sheet and with a unique identification code during regular supply and when in development phases. During a development phase, the identification may be temporary.
The supplier may not make any changes to the goods and/or to the production process, including changes of location of manufacturing, process/equipment of manufacturing, and/or raw materials/components from incumbent or new/alternative sub-suppliers, unless such changes have been communicated to and agreed in writing by the authorized Essity contact. This applies to all changes except minor process optimization and minor maintenance changes that have no impact on the delivered goods and do not inhibit the supplier’s compliance with this Supplier Standard and other applicable requirements. The time frame for communication must be a minimum of three (3) months, preferably six (6) months in advance of commercial deliveries, except for changes that are due to unforeseeable events beyond the supplier’s control and that are thus unavoidable. Essity’s approval of a change will not relieve supplier of its obligations and responsibilities. A new goods identification code shall be used if raw materials /components or process conditions change significantly, particularly if the changes may influence the goods’ chemical composition.
The supplier shall ensure that processes are implemented under controlled conditions including the following:
- Process results shall be continuously controlled toward the target value for relevant properties
- Process capability shall be completed and documented
- Statistical techniques shall be used to demonstrate that a process is capable and in control, and if applicable, include the use of Cpk/Ppk (process capability index) for capability studies
- Control plans shall be documented and demonstrate compliance with Essity requirements and other applicable requirements in the relevant field. The characteristics of a control plan shall be identified through risk assessments
- Where applicable, automatic feedback and control systems and/or SPC (Statistical Process Control) shall be implemented. Process variations shall be evaluated continually and the causes of uncontrolled variations eliminated
- Preventive maintenance of equipment shall be carried out to ensure continuous process capability
3.9 Design and development
The development and launch of new goods shall follow a documented cross-functional process. The process description shall include:
- How Essity’s expectations and requirements are taken into account, including timelines
- How goods in the development phase are transferred to regular production
- How parameters necessary for repetitive production of goods in the development phase are documented, e.g. goods composition, process parameters
- Process capability analysis, also valid for pilot machines, when applicable
- Patents and other intellectual property
- Cost analysis
- Regulatory and product safety aspects
- Environmental aspects including energy
- Occupational health and safety aspects
3.10 Product safety and hygiene control
Documented procedures shall be established for product safety hygiene control and related processes (see chapter on product safety).
3.11 Identification and traceability
The supplier shall establish and maintain procedures that allow the traceability of goods and the raw materials/components used in production of the goods. The traceability system shall be tested regularly. Traceability records needed to identify delivered goods, which have a risk of non-conformity, shall be made available to Essity on demand and in critical situations on short notice. Goods identification shall be recorded in a manner that permits relevant recall procedures. This procedure shall be documented and tested.
3.12 Root cause analysis and action plan
Supplier shall perform a root cause analysis with respect to all reported quality claims in order to avoid repeat defects in future deliveries. Corrective and preventive actions shall be presented to Essity, including a short and long-term action plan.
Vehicles shall be suitable for transportation of the relevant goods and should be regularly cleaned and inspected to ensure that they are free of odors and contamination. All vehicles, regardless of source, shall be inspected before loading and records of inspection kept. All goods must be prepared for shipment in a manner to prevent damage, contamination or other deterioration of the goods.
3.14 Internal audits
Supplier internal audits shall include the requirements of the Supplier Standard, with special attention to the traceability system.
Personnel performing tests on raw materials /component properties and/or goods shall be proficient in using test methods. Test methods used shall be well defined, validated, documented, and preferably in compliance with a recognized standard for the specific industry. All measuring instruments shall be calibrated and checked utilizing a metrology system.