Quality

3.1 Quality management system

Essity requires Supplier to 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 regulated products requiring compliance with specific standards and/or Good Manufacturing Practices, GMP, Supplier must have the appropriate certification, valid for the intended market (for example ISO 13485 for certain Medical Devices, ISO 22716 or equivalent for Cosmetics, GFSI for certain Food or Food Service Products, etc.)

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 consider the factors specified in Annex A1. All risk assessments shall be documented and kept updated.

Supplier’s 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 in compliance with all relevant legislation and operate in a safe and secure environment including restricted access to the site and minimized risk of goods contamination.   

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

Supplier’s organization shall have a good understanding of the following:

• Products, services, process and quality assurance in Supplier’s field of activity
• Supplier’s own market status
• Patents and other intellectual property in 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 and or batch record (if required) 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 as well as in development phases. During a development phase, the identification may be temporary.

If after delivery of the goods, Supplier becomes aware of a condition that may indicate that the specification has not been obtained, Supplier shall notify Essity immediately. 

3.9 Change Management

Supplier may not make any changes to the goods and/or to the production process, unless such changes have been communicated to and agreed in writing by the authorized Essity contact. This applies to all changes including changes of:

• Location of manufacturing
• Process/equipment of manufacturing
• Raw materials/components from incumbent or new/alternative sub-suppliers

Minor process optimization and minor maintenance changes that have no impact on the delivered goods and do not inhibit Supplier’s compliance with this GSS and other applicable requirements are exempt of this requirement.

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 Supplier’s control and that are thus unavoidable. The time frame for communication may be longer if required by regulations applicable to the product.

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.

3.10 Production processes

Supplier shall ensure that production 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; other methods of validation shall be applied when appropriate or required
• 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 
• Preventive maintenance of equipment shall be carried out to ensure continuous process capability
• 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.

3.13 Root cause analysis and action plan

Supplier shall perform a root cause analysis with respect to all reported quality complaints in order to avoid repeating defects in future deliveries. Corrective and preventive actions shall be presented to Essity, including a short and long-term action plan.

3.14 Storage and Transport

Goods shall be stored in adequate conditions. Vehicles shall be suitable for transportation of the relevant goods and should be regularly cleaned and inspected to ensure that they are free from damage, 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.

3.15 Internal audits

Supplier internal audits shall include the requirements of the Supplier Standard, with special attention to the traceability system.