Process instruction Documented information

These procedural instructions describe the handling of the documented information required by the standards in the form of documents, data and records as well as the handling of the documented information that we ourselves consider necessary to meet our customer requirements. The procedural instruction includes the creation, updating and control of documented information. The release is described in the release process .

• Specification documents, e.g. B. Manual, instructions (process, work and test instructions, forms for records)

• Plans, e.g. B. Audit plan, training plan

• Lists, overviews

• Test reports (e.g. acceptance report)

• Test records of the test equipment monitoring

• Evidence of the control of defective products

• Evidence of corrective and preventive actions

• Evidence of internal quality audits (e.g. audit plan, audit report)

• Proof of training (e.g. employee instruction)

The QM officer is responsible for monitoring, adapting, issuing and blocking controlled documents in ARTS Solutions GmbH. He can delegate this to the relevant specialist. The responsibility for checking changed documents lies with the QM officer or his deputy in the event of absence or the creation of the document to be checked by the QMB. The GF is responsible for the release.

The creation, checking and approval of documented information with the character of a request (documents) and data is carried out by qualified and authorized persons in accordance with the defined responsibilities.

When creating documented information, compliance with formal, company-specific regulations is mandatory. These can be found in the CD guide .

Documented information with a requirement character is checked for accuracy and appropriateness in terms of content before it is released and approved in compliance with the dual control principle.

The revision status is clearly shown on the documented information.

Tracking is carried out in odoo using the valid documented information with the character of a requirement, such as the manual, process and work instructions and relevant forms. 

Every six months, the existing documented information must be checked in addition to the set test dates for the respective documents. This includes, in particular, checking whether the existing documented information still fits the current situation of the company. 
Sources for this are in particular the current project situation, specifications from the group and other changes in internal and external topics. One of these reviews is carried out in connection with the management review. 

If deviations are found in this context, these must be dealt with by expanding or updating documented information. 

Evidence must be adequately traceable, identify the creator, the date, a designation and, if necessary, a reference. Evidence must be provided by the creator with his or her signature or digital signature. Evidence must be checked for plausibility by the creator in order to avoid incorrect documentation.

The issuing and archiving of documented information are the tasks of the persons authorized for this according to the defined responsibilities.

The release of documents and data requires their prior examination and approval.

The archiving of documented information takes place according to internally defined and / or legal requirements. It must always be carried out in such a way that the documented information can be retrieved or retrieved with reasonable effort. The archiving period is usually 10 years, provided there are no legal or contractual regulations that deviate from this. In the case of critical documents (e.g. stamp lists for traceability), a retention period of 30 plus 6 years applies. Archiving takes place in odoo.

The change of documented information takes place on the basis of the defined release process .

The documented information is saved on the internal systems in accordance with the required specifications at regular intervals. An access concept regulates the allocation of rights. In addition, technical and organizational measures have been taken to ensure that the data is backed up under the various aspects.

The backup concept, password guideline, rights concept and data backup concept are managed by ARTS Holding in cooperation with Manatec and are available to them in a documented form.