ASQ CMDA Certification Exam Sample Questions

CMDA Dumps PDF, Medical Device Auditor Dumps, download Medical Device Auditor free Dumps, ASQ Medical Device Auditor exam questions, free online Medical Device Auditor exam questionsYou have to pass the CMDA exam to receive the certification from ASQ. To increase the effectiveness of your study and make you familiar with the actual exam pattern, we have prepared this ASQ Medical Device Auditor sample questions. Our Sample ASQ Certified Medical Device Auditor Practice Exam will give you more insight about both the type and the difficulty level of the questions on the ASQ Medical Device Auditor exam.

However, we are strongly recommending practice with our Premium ASQ Certified Medical Device Auditor (CMDA) Practice Exam to achieve the best score in your actual ASQ CMDA Exam. The premium practice exam questions are more comprehensive, exam oriented, scenario-based and exact match of ASQ Certified Medical Device Auditor exam questions.

ASQ Medical Device Auditor Sample Questions:

01. A firm's CAPA for repeated software anomalies in a software-as-a-medical-device product shows the specific defect was patched and affected installations were updated, and the CAPA was marked closed. During follow-up, the auditor notes the firm never determined why the defect escaped design verification.
How should the auditor evaluate this closure?
a) The finding should simply be reclassified as a preventive action.
b) Closure is justified because the product now conforms to specification.
c) Closure is not justified, because without understanding why verification failed to catch the defect, recurrence prevention remains unverified.
d) Closure is justified because the specific software defect was patched and every affected field installation was updated to the corrected version.
 
02. A supplier defends a marginal lot by telling the auditor that its sampling plan has a stated acceptable quality limit of, hypothetically, 1.0 percent, so the supplier considers up to 1.0 percent nonconforming to be an acceptable ongoing target for shipped product.
How should the auditor evaluate this reasoning?
a) The reasoning is correct because the plan already accounts for consumer risk
b) The reasoning is acceptable only if the lot size is large enough
c) The reasoning is sound, because the sampling plan permits that percentage of nonconforming units as an ongoing quality target for every shipped and delivered lot
d) The reasoning is flawed, because the acceptable quality limit is a sampling-plan parameter, not a licensed target defect level for delivered product
 
03. An auditor reviews the usability engineering file for a new autoinjector. The manufacturer conducted testing only during early prototype stages, using three of its own design engineers as participants.
What is the most significant deficiency in demonstrating that the user interface is safe for the intended users?
a) Formative testing should never have been performed at the prototype stage.
b) No summative usability evaluation was performed with representative users under actual or simulated use to show that safety-critical tasks can be completed safely.
c) Three participants of any background already exceed the number of test users needed to validate the interface, so no further evaluation with representative users under simulated use conditions is required.
d) Design engineers are the ideal representative users for the study.
 
04. In a system audit of a sterile single-use device manufacturer, one of thirty sampled device history records is missing a single operator initial. All other sampled records are complete and the record-control procedure is otherwise followed.
How should the auditor most appropriately classify this observation?
a) Major nonconformity requiring immediate suspension of the firm's quality-system certificate and a halt to further product release.
b) Not reportable, because twenty-nine of thirty records were fully correct.
c) Minor nonconformity, as an isolated lapse that does not indicate a breakdown of the record-control system.
d) Major nonconformity, because any device history record defect inherently endangers patients.
 
05. Midway through a two-day audit of a diagnostic imaging manufacturer, the audit team is running behind schedule because one auditee repeatedly delays producing requested records.
How should the lead auditor best manage the on-site audit?
a) Hold a brief team review, reprioritize toward the highest-risk areas, and raise the delays with the auditee's management contact

b) Extend the on-site audit open-endedly for as many additional days as it takes until every single planned record across every area has been produced and reviewed

c) Accept the auditee's verbal assurances and waive the need for the records
d) Quietly drop the delayed area and issue the report as though it were fully covered
 
06. Rather than auditing one procedure at a time, an experienced auditor at an infusion-pump manufacturer follows a single customer complaint through complaint handling into risk review, CAPA, and any resulting design change, examining how each hand-off works.
Which auditing approach does this best illustrate?
a) A vertical audit limited to a single department's paperwork
b) A financial audit of the cost of processing customer complaints
c) An element approach that inspects each individual standard clause and documented procedure separately, in isolation from the others
d) A process approach that audits the linkages and interactions between related processes
 
07. The agreed completion date for a corrective action responding to a major nonconformity has passed, and the auditee has provided no evidence that the action was completed.
What is the auditor's most appropriate next step?
a) Escalate the overdue action per the audit program; the nonconformity remains open and unverified, and closure cannot proceed.
b) Downgrade the nonconformity to an observation so it can be closed out.
c) Close the finding administratively because the agreed completion deadline has already elapsed, treating the lapsed date as sufficient grounds for closure.
d) Recommend certification on the assumption that the auditee will comply in good faith.
 
08. While auditing a sterile single-use catheter line, the auditor is handed two documents by different staff: one is described as the master specification set used to manufacture the device, and the other as the record of what was actually done for a specific production lot.
Which pairing correctly identifies these two documents?
a) The master specification set is the Device History Record (DHR); the lot record is the Device Master Record (DMR)
b) Both documents are parts of the Design History File (DHF)
c) The master specification set is the DMR; the lot record is the Technical File
d) The master specification set is the Device Master Record (DMR); the lot record is the Device History Record (DHR)
 
09. While touring a device-assembly area, an auditor observes a program of sorting, setting in order, shining, standardizing, and sustaining workplace organization to reduce wasted motion and searching.
Which Lean technique is being applied?
a) 5S workplace organization

b) Acceptance sampling

c) Statistical process control
d) Design of experiments
 
10. Before a third-party certification audit of an orthopedic device firm, the registrar reviews the assigned auditor's history.
Which situations create a conflict of interest that should disqualify the auditor from this engagement?
(Choose two.)
a) The auditor previously certified a competitor of this firm in the same device sector
b) The auditor provided paid consulting to design this firm's CAPA system within the recent past
c) The auditor attended a public standards-training course taught by an industry trade association several years ago
d) The auditor is fluent in the standard and has audited many implant manufacturers
e) The auditor holds a financial ownership stake in the firm being audited

Answers:

Question: 01
Answer: c		 Question: 02
Answer: d		 Question: 03
Answer: b		 Question: 04
Answer: c		 Question: 05
Answer: a
Question: 06
Answer: d		 Question: 07
Answer: a		 Question: 08
Answer: d		 Question: 09
Answer: a		 Question: 10
Answer: a, e

If you find any errors or typos in ASQ Certified Medical Device Auditor (CMDA) sample question-answers or online ASQ Medical Device Auditor practice exam, please report them to us on feedback@processexam.com

Your rating: None Rating: 5 / 5 (75 votes)