CQP Foundation Level
Documentation and Records Management for Quality flashcards
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What is the difference between a document and a record in a quality system?
A document says what should happen: a policy, procedure, work instruction, specification or blank form. It is prospective and is revised, and only the current revision is valid. A record says what did happen: a completed form, a result, a report. It is retrospective and fixed once created; if it is wrong you add a correcting record and keep both.
What four characteristics must a record have under ISO 15489?
Authenticity: it is what it purports to be, made by the purported person at the purported time. Reliability: its contents are a full and accurate account, captured at or near the time by someone with direct knowledge. Integrity: it is complete and unaltered, and any permitted addition is identified and traceable. Usability: it can be located, retrieved, presented and interpreted while it is needed.
What are the stages of the records life cycle?
1. Creation or receipt: made or received and captured with its metadata. 2. Active use: consulted regularly, more than once a month, in the registry or office of origin. 3. Semi-current: consulted less than once a month, moved to a records centre. 4. Appraisal: assessed against the retention schedule. 5. Disposition: destroyed, transferred to archives, or retained permanently.
Several legal and business requirements apply to one record class. How is its retention period set?
The longest applicable requirement governs, never an average and never the period the department prefers. List the competing periods, pick the longest, and state the trigger it runs from (creation, file closure, end of contract, end of employment). A legal hold overrides the schedule while litigation, an investigation or an access request is pending.
Which two Kenyan Acts govern the disposal of records, and what does each cover?
Public Archives and Documentation Service Act (Cap 19): public records generally. It establishes the Kenya National Archives and Documentation Service, and public offices may not destroy public records without the Director's authority. Records Disposal Act (Cap 14): the disposal of court records and prescribed statutory registers.
What does the storage limitation principle of the Data Protection Act, 2019 mean for a retention schedule?
Personal data may be kept in a form that identifies the data subject for no longer than is necessary for the purpose. Indefinite retention is itself a breach, so every class needs a defined period and trigger, and disposal must actually happen. The schedule now sits between a floor set by evidential and tax law and a ceiling set by data protection law.
On what conditions does the Evidence Act (Cap 80) let an electronic record be relied on?
The party relying on it must be able to show that: the system was operating properly; the record was produced in the ordinary course of business; its integrity has been maintained. That is why audit trails and access controls are legal controls, not only technical ones.
How does a standard differ from a specification?
Standard: developed by consensus through a recognised body, of general application in a field, voluntary unless made compulsory by law. Example: ISO 16175. Specification: written by a purchaser, designer or single organisation for a particular transaction, detailed, and contractually binding on the parties who adopt it. Example: a county's EDRMS tender specification. A good specification cites standards rather than repeating them.
What is the declaration point in an EDRMS, and why does it matter?
Declaration is the act by which a document becomes a record, after which it is locked and cannot be altered. Before it, the document can be checked out, edited, versioned and deleted. After it, the record carries mandatory metadata, a classification and a retention rule. A system with no declaration moment is a document management system, whatever it is called.
What are the RPO and the RTO in a continuity plan?
Recovery Point Objective (RPO): how much data you can afford to lose, measured backwards from the incident. It sets backup frequency. Recovery Time Objective (RTO): how long you can afford to be down. It sets the recovery infrastructure. Both are business decisions costed against loss, not technical preferences.
What does KS ISO 9001:2015 mean by documented information to be maintained and to be retained?
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What controls make up document control?
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How is an error on a paper record corrected properly?
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What are the levels of the documentation hierarchy, from top to base?
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Does ISO 9001:2015 require a quality manual?
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What are vital records, and how are they protected?
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Name six benefits of systematic records management.
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What are the stages in the development of records management?
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What are the eight principles of records management?
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How does the records continuum model differ from the life cycle model?
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What values does appraisal look for in a record?
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What is a legal hold?
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What are the three forms of disposition?
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What retention periods apply to employment records and to contracts in Kenya?
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How long must books of account and company statutory registers be kept in Kenya?
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What does the Access to Information Act, 2016 require of a public entity?
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On what grounds may access to information be limited, and what check applies?
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What does KS ISO 9001 clause 7.5 require when documented information is created, updated and controlled?
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What is the test of a good records management policy statement?
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What are the data protection principles in section 25 of the Data Protection Act, 2019?
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When must a personal data breach be notified under the Data Protection Act, 2019?
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Under the Copyright Act, 2001, when does protection arise and who owns a work made by an employee?
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How do structured, semi-structured and unstructured electronic records differ?
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What is format obsolescence, and how is it controlled?
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Why is a digitised record treated differently in evidence from a born-digital one?
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What does ISO 15489-1 supply?
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What do ISO 30301, ISO 16175 and ISO 23081 each cover?
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What are ISO 14721 and ISO 19005?
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Give five records KS ISO 9001:2015 requires to be retained, with their clauses.
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What is an ERKS, and how does it differ from an EDRMS?
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Why is a business classification scheme built on functions rather than departments?
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Where does an EDRMS implementation start, and what metric predicts its success?
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What are the four phases of disaster management for records?
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How should wet paper records be handled after a flood?
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What is the difference between preservation and conservation?
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What environment should a paper records store keep?
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What is the main risk of smart automation in records management, and its control?
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Who is accountable when an AI tool misclassifies or wrongly discloses a record, and what is the practical control?
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What contractual controls should a cloud records contract contain?
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What is information governance, and what is the commonest failure it addresses?
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