How are quality records identified?
“Quality records should give evidence directly or indirectly as to whether or not the product meets specified requirements.” Evidence is identified by your procedures including Management Review, Process Control, Inspection Requirements, Quality Audits and Corrective and Preventive Action and Customer Complaints.
What are examples of quality records?
Examples of quality records are: program definition and requirement documents, product change requests, bill of material lists, product prints (both 2-D and 3-D), validation and verification test results, design review documents, virtual analysis reports, some types of meeting minute, run at rate results, PFMEAs.
What are considered quality records?
Quality Records means Documents containing recorded information, regardless of the medium or characteristic, which demonstrate the effectiveness of the quality management system and that provide evidence that products meet regulatory requirements and comply with specified product requirements.
What is identifying information on record?
Personally identifying information Identifying information means information that identifies an individual or for which it is reasonably foreseeable in the circumstances that it could be utilized, either alone or with other information, to identify an individual.
How long should you keep quality records?
Assuming your legal research was thorough, it is best to maintain the records for three years. You must, however, document your search effort and the assumptions you used to set the three-year period.
How are quality assurance records stored?
The remainder of the quality literature, records and documents are held by the quality assurance manager in a quality records file or in marked locations, while master documents are also held in a secure electronic location, or in a hard back folder. All locations must be logged and accessible to authorised staff.
What is a QA record?
4.1 Quality Assurance Record – An individual document or other item that has been executed, completed, and approved and that furnishes evidence of the quality and completeness of data (including raw data), items, and activities affecting quality; documents prepared and maintained to demonstrate implementation of …
What is a QA form?
Quality Assurance (QA) evaluation forms are used to review the work of agents, including how they handle calls. QA scores and other data collected from the forms is used for reporting. If a form has been used, and you then determine that changes are needed, you can edit and save it as a new form.
What is obsolete copy?
Obsolete documents: When a document is tagged as being obsolete, it means that it is no longer appropriate for the purpose it was created for. For example, a very old procedure that is no longer applicable to the current process due to advancements in technology would be considered obsolete.
What is a controlled copy?
Definitions/Acronyms Controlled Copy: A controlled copy is a formal copy of the latest, correct issue (approved version) of a document; an identified issue of a document to an individual or location of record.
What are examples of permanent records?
Examples of permanent records are the original process in a civil or criminal proceeding and the minutes of the city’s governing body. Some records, such as deeds, are kept permanently because the record continues to have legal significance in perpetuity.
When did quality records come out in Canada?
Quality Records was a Canadian entertainment company which released music albums in Canada on behalf of American record labels. They also released recordings by Canadian artists. The company operated between 1950 and 1985 with offices in Toronto.
Which is the best definition of Quality Records?
Quality Records means the Quality Records referred to and described in paragraph 2 of this Schedule 6.
How to structure quality management system documentation ISO 9001?
The QMS documentation can consist of different types of documents. Usually, it includes documents such as the Quality Policy, Quality Manual, procedures, work instructions, quality plans, and records. The QMS documentation can be represented as a hierarchy, as shown in the diagram below: ISO 9001 requires different types
What are the different types of QMS documentation?
QMS documentation hierarchy. Usually, it includes documents such as quality policy, quality manual, procedures, work instructions, quality plans, and records. The QMS documentation can be represented as a hierarchy as shown in the diagram below: ISO 9001 requires different types of information to be documented; however,…