Quality

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.

3.4 Competence

• 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 requirements

Relevant 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

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.

3.8 Processes

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

3.12 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.

3.13 Transport

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.