Nonconformity finding in pharmaceuticals during Audit is a very crucial stage, where finding non-conformity becomes a hurdle for the organization. Nonconformity may be major or minor types it depends on what type of process is affecting at what level.
What is Nonconformity
As per ISO 19011 “Nonconformity” means non-fulfillment of a requirement, against ISO 9001 clause or Auditee’s QMS documents like Manual, Procedure/ Work Instruction Etc
When a person, process, or product fails to meet a requirement of the system is non-conforming in some way.
Related: Deviation, and its types
What is Nonconformity Evidence
Evidence is verifiable and comes from:
» Process Name (core process or support process )
» Document references
» Serial numbers
» Sample size
» Time and location
» Description of the possible consequences of the non-conformity
» Auditee’s Statements
Discussing a Nonconformity
On finding evidence of nonconformity discuss the situation with the officer/manager responsible for the area and:
1. Agree on the requirement
2. look for opposing evidence
3. Make notes and evaluate evidence
4. Reach a conclusion
5. Agree on the conclusion
6. Never agree on nonconformity with an operator.
Documenting a non-conformity
- Write the statement of nonconformity:
- There are three parts to a well to a well-documented
- the audit evidence to support auditor to support the auditor’s findings;
- a record of the requirement against of the requirement against
- which the non-conformity is detected;
The statement of non-conformity
State clearly what the problem is. Phrases such as ‘evidence of ….’, ‘However ….’, or ‘no evidence of …..’ are usually good to use.
Make sure to stick to the real facts and don’t imply opinions/concepts unless you have strong evidence that what has been seen really applies to everything.
The statement of nonconformity drives the cause analysis, correction, and corrective action by the organization so it needs to be organization, so it needs to be precise.
Major Or Minor Non-conformity
It is of two types; Major and Minor
Major non-conformity
- Chronic/repetitive problem Chronic/repetitive problem
- System breakdown
- Adversely affecting the environment or the customer (core process)
Minor non-conformity :
- Isolated implementation problems
- Support process
Compliance Vs Conformance Non-conformity
compliance Nonconformity: It is due to the non-fulfillment of ISO 9001 standard requirements it will be called compliance type of Nonconformity requirements.
conformance Non-conformity: It is against the documented system of organization, it will be a conformance kind of NC
Non-conformity Statement – Example 1
Non Conformity
Slip gauge # AP-G-001 had not been calibrated per frequency.
Requirement
ISO 9001:2000 – clause 7.6 a) states that measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use,
Objective Evidence
In Gauge, AP-G-001 Room, Slip gauge set serial number AP-G-007, used as a standard to calibrate other gauges, was due for recalibration 2 months ago, on 20 Aug XXXX…, which did not happen”
Non-conformity Statement – Example 2
Non Conformity
In spite of major organizational change, departmental procedures were In spite of major organizational change, departmental procedures were not updated to current practice.
Requirement
ISO 9001:2000 Clause 4.2.3 expects to review and update as necessary and re-approve documents.
Objective Evidence
Controlled procedures QSP-XXX-01 dated XX.XX.XXXX is not updated against organizational major change
Reference:
ISO 19011:2018(en) Guidelines for auditing management systems
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