Document and Record Control
In a quality management system, people need dependable instructions before they work and dependable evidence afterward. Document and record control supports both needs.
This lesson follows an inspection form through its life: an approved blank form, a completed record, a later revision, and eventual retrieval. Watch for the difference between changing instructions and preserving history. Also notice who approves changes, how people find the applicable version, and what makes a correction trustworthy.
Instructions and evidence
A procedure, specification, drawing, or blank inspection form directs work. It is a document. A completed inspection form provides evidence of what actually happened. It is a record.
The person doing the work needs the applicable approved instruction. Someone reviewing the record needs the relevant identity, date, results, and authorization. These are related purposes, but they are different.
If the blank form changes next month, the records completed today do not change with it. They remain evidence of the earlier activity and must remain understandable in that context.
A revision needs a controlled decision
Before an instruction is issued, it is reviewed and approved for adequacy. An edited file is only an edited file until the applicable approval and issue controls have been completed.
Changes need to be identifiable, reviewed, and reapproved by the original approving function or another designated function with the necessary background. This ensures that the people making the decision can assess what the change means.
The Quality Manager may coordinate that work. Coordination does not automatically make that person the technical approver for every drawing, test method, or specification.
Bring the change to the work
Approval is part of the change, but the revised instruction must also reach the people who need it. Check what else depends on the change: related procedures, forms, training, and connected processes.
Imagine that the inspection method changes, but an operator still has the old form and instructions at the bench. The electronic master may be correct while the actual work remains inconsistent.
Follow the change all the way to its point of use. The practical outcome is that people can identify and use the applicable approved instruction when they perform the work.
Control old and external copies
An obsolete instruction left at a workbench can be used by mistake. Controls should prevent that unintended use while preserving historical material that must be retained.
External documents also matter. A supplier specification or a test method may define how your organization works, even though someone else wrote it. Necessary external documents need identification and controlled distribution.
A working web link does not prove that the document at the other end is the applicable version. Check its identity and applicability rather than treating accessibility as evidence that it is current for your work.
Record the event honestly
Record observations when the work occurs, using your own authorized identity. A reliable record should allow another person to understand the actual event.
If information is wrong, make the correction identifiable and preserve the original information. Follow the record-control procedure for documenting the correction and its reason when appropriate.
Do not silently replace an unfavorable result, predate a sign-off, or fill a missing observation from memory as if it had been recorded at the time. A transparent correction preserves the history of the record instead of creating a misleading one.
Protect the evidence
Records need protection from unauthorized changes. Confidential information also needs appropriate protection, including patient information that may appear in complaint records.
Think about both integrity and access. Authorized people need to retrieve the evidence, while access and editing controls protect it from inappropriate use or alteration.
An electronic record that cannot be opened is not useful evidence simply because a filename still exists. Readable formats, backups, and continuing access to the systems needed for retrieval are part of maintaining usable records.
Retention has a reason
Retention is based on the device lifetime, applicable regulatory requirements, and the type of record. A convenient annual cleanup schedule is not a substitute for that basis.
Define how records are stored, retrieved, protected, and eventually disposed of. This includes planning for electronic systems that may change over time.
When an inspection form is revised, new work uses the new approved form as applicable. Earlier completed records remain intact and retrievable for their required retention period. Updating the method and preserving the evidence are both parts of control.
Follow one form through its life
Follow one inspection from beginning to end. Before work starts, the operator finds the approved instruction and form. During the inspection, the operator records the actual observations. If a correction is needed, its history remains visible.
Later, a revised form becomes available for new work. The earlier record is not rewritten to look like the new form. When someone needs to understand the original inspection, they can retrieve its evidence.
That is the connection: controlled instructions guide the activity, and controlled records preserve what happened.
What to carry into your work
When reviewing document control, ask whether the right instruction reaches the right person. When reviewing record control, ask whether the evidence is honest, protected, and retrievable. Those questions help turn file management into dependable support for the work.
This lesson draws on the AAMI and ISO practical guide to ISO 13485, section four point two, especially document and record control. The examples are educational. Applicable requirements and your company's approved procedures govern actual work.
SOURCE CREDIT AAMI/ISO 13485:2016 — Medical Devices: A Practical Guide (ISO 2017), §4.2, especially §§4.2.4–4.2.5; purchased through ANSI. This video presents original educational explanations informed by the guide. It is not an official AAMI, ISO, ANSI or FDA course. Applicable requirements and company procedures govern actual work.