Checklist Phase 2 - Documents and records

Does the laboratory have an overview of the time each type of record should be archived?

Activity

Does the laboratory have an overview of where each type of record should be archived?

Activity

Are SOPs available at logical locations, at least:

  • Near the place where the procedures the SOPs describe are routinely performed
  • In the office areas
  • In the dedicated quality documents archive

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Are inconsistencies and errors found in documents recorded in a Document Revision Form?

Activity

Do staff members know where to find the Document Revision Form?

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Do staff members know what the Document Revision Form is for and do they know how to use it?

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Is a Document Control Log available that shows all the quality documents of the laboratory with at least the following details:

  • The document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before which the document must be reviewed
  • Distribution list
  • Remarks
  • The title of the previous version
  • The name of the author of the previous version
  • The names of the reviewers of the previous version
  • The name of the authorizer of the previous version
  • The date on which the previous version was released for use
  • The date on which the previous version was replaced

Activity

Is each quality document (SOP, quality manual chapter, Biosafety Manual chapter) supplied with a front page that contains the following information: [tick off]

  • Document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before the document must be reviewed
  • Distribution list
  • Description of changes compared to previous version

Activity

Does the laboratory have a document control system that ensures that all its quality documents are reviewed, and, when necessary, revised on an annual (or, after maturation of the quality management system, biannual) basis?

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Are the Bench Aids used in the laboratory based on current versions of SOPs?

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Have all quality documents currently in use been reviewed by at least one reviewer?

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Are all the quality documents used in the laboratory authorized for release?

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Are copies of replaced quality documents in the quality documentation archive clearly marked as “replaced” with the date on which they were replaced?

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Are all the references in quality documents to other documents, locations and equipment correct?

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Does the laboratory have a dedicated archive in which it stores all its current and replaced quality documents for a period of five years?

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Are all the procedures related to the document control system standardized in an SOP?

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Is staff aware of what they have to do when they detect an error in a quality document?

Take a sample by asking several staff members.

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Are the Equipment SOPs complete, i.e. do they include the procedures that were developed in phase 2 such as calibration, preventive maintenance and corrective maintenance?

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