Independence Matters
+1 510 397 9739
sam@lazzara.net
sam@lazzara.net
Did you ever notice that in most judicial systems, the Judge is independent from the Plaintiff and Defendant? And in most sporting events there are (presumably) impartial judges and referees?
It is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work. This belief has influenced medical device regulation and standards significantly, and the trend continues. Here are some examples of requirements for independence.
RESPONSIBILITY
ISO 13485:2003 clause 5.5.1
Top
management shall ensure that responsibilities and authorities are defined, documented
and communicated within the organization. Top
management shall establish the interrelation of all personnel
who manage, perform and verify work affecting quality, and shall ensure the
independence and authority necessary to perform these tasks.
US FDA 21 CFR 820.20 Management responsibility.
(b) Organization. (1) Responsibility and authority.
Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
(b) Organization. (1) Responsibility and authority.
Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
QUALITY AUDITS
ISO 9000:2005
Audit – systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled.
US FDA 21 CFR 820.3(t)
Quality audit means a systematic, independent examination of a manufacturer's quality
system...
ISO 13485:2003 clause 8.2.2 Internal audit
Selection of auditors and conduct of audits shall ensure objectivity and impartiality of
the audit process. Auditors shall not audit their own work.
US FDA 21 CFR 820.22 Quality audit
Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.
DESIGN REVIEW
US FDA 820.30 Design controls (e) Design review. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
DESIGN VALIDATION
IEC 60601-1:2005, section 11.4 (PEMS = Programmable ElectroMedical Systems)
The person having the overall responsibility for the PEMS validation shall be independent of the design team. The manufacturer shall document the rationale for the level of independence. No member of a design team shall be responsible for the PEMS validation of their own design. All professional relationships of the members of the PEMS validation team with members of the design team shall be documented in the Risk Management File.
USABILITY VALIDATION
IEC 62366:2007 (EN 62366:2008), 5.9 Usability Validation
The manufacturer shall validate usability of the medical device according to the Usability Validation Plan. The results shall be recorded in the Usability Engineering File.
NOTE 4 - Individuals that were not directly responsible for the User Interface design should be involved in the usability validation.
