CODE: PR-002

10
08/10/13
CORRECTIVE, PREVENTIVE, and
IMPROVEMENT Page 1 of 12

1. OBJECTIVE

Define methodologies and criteria for identifying and analyzing the causes of No
Real or potential non-conformities, taking into account opportunities for improvement
that can be identified within the development of the activities related to
IMCOLMEDICA S.A.

2. SCOPE

This procedure covers corrective, preventive, and improvement actions.

addressed in the quality management of the company to the following aspects:

o Quality management system (requirements, processes, and documents)

o Quality Management System (regulatory requirements for devices
doctors)
o Product-related requirements
o Customer Relationship (Complaints and Claims)

It takes effect from the date of publication and applies from the moment it is detected.
or determines a nonconformity, up until the moment it is closed, that is when
the effectiveness of the actions taken to prevent them from happening again has been verified
occur

3. REFERENCE DOCUMENTS

NTC ISO 9000 Quality Management System. Fundamentals and Vocabulary.

NTC ISO 9001 Quality Management System Requirements.
NTC ISO 13485 Requirements for Regulatory Purposes.

4. DEFINITIONS

CORRECTIVE ACTION: Action taken to eliminate the cause of a non-conformity.

compliance detected or another undesirable situation, with the aim of
this should not happen again.
PREVENTIVE ACTION: Action taken to eliminate the cause of a non-conformity.
potential conformity or another undesirable potential situation.
APCM: Preventive, Corrective, and Improvement Actions.

1
 CODE: PR-002
VERSION: 10
10/08/13
CORRECTIVE, PREVENTIVE actions and
IMPROVEMENT Page 2 of 12

CORRECTION: Action taken to eliminate a detected non-conformity.

CONTINUOUS IMPROVEMENT: Recurring activity to increase the capacity to
meet the requirements.
NON-COMPLIANCE: Failure to meet a requirement.
REQUIREMENT: Established need or expectation, generally implicit
(which is common) or mandatory.
VERIFICATION: Confirmation through the provision of objective evidence
that the specified requirements have been met.
OBJECTIVE EVIDENCE: Data that supports the existence or truth of
algo.
Revision: Submission of a thing to a new examination to correct it.
repair it or check its operation and validity.
EFFECTIVENESS: The extent to which planned activities are carried out and
they achieve the planned results.
EFFICIENCY: Relationship between the result achieved and the resources used.
FOLLOW-UP: Periodic reviews conducted on the status of
implementation and compliance with the actions generated for the closure
respective of the action.
RECURRENCE: Action that occurs more than once.

5. RESPONSIBLE PARTIES

To enforce this procedure:

All the staff of IMCOLMEDICA S.A.

Directors and/or Area Coordinators of IMCOLMEDICA S.A.
Quality and Project Coordinator
The Quality Assistant.

For the update and dissemination of the changes to the procedure:

The Quality and Projects Coordinator.

The Quality Assistant.

For the proper implementation of the updated versions:

Manager
Directors and/or Area Coordinators of IMCOLMEDICA S.A.

2
 CODE: PR-002
10
08/10/13
CORRECTIVE, PREVENTIVE, and
IMPROVEMENT Page 3 of 12

Quality and Projects Coordinator

Quality Assistant

6. DESCRIPTION OF ACTIVITIES

6.1. DETECTING NONCONFORMITY.

Any area of IMCOLMEDICA S.A can detect deviations caused by;

a. Review of customer complaints and claims.

b. Management review (see PR-016 MANAGEMENT REVIEW).
c. Internal Quality Audits (see procedure PR-013 AUDITS
INTERNAS
d. Supplier Evaluation
e. No nonconformities detected in the development of processes.
f. Non-compliance with the standards applicable to certifications
and accreditations from IMCOLMEDICA
g. Non-compliance with applicable legal requirements
h. Non-conforming Products
i. Communications and complaints made by users or other stakeholders

In any case, the information must be directed to the Assistant of

quality, which will be analyzed together with the leader of the involved process No
Conformity, the root cause of the non-compliance presented, to establish the
immediate corrective action to the deviation and the possible APCM.

6.2. REQUEST THE PREVENTIVE, CORRECTIVE AND ACTION

IMPROVEMENT

Once the Existing Non-Conformity has been detected and reported, Non-Conformity
Potential and/or Opportunity for Improvement, the quality assistant must record it in the
FM-004 format "Request for Preventive, Corrective and Improvement Actions"
recording the following information.

Code assigned to the APCM

Type of Corrective, Preventive or Improvement Opportunity Action
Fountain of the Fault
Management Review
Supervision and Inspection

3
 CODE: PR-002
VERSION: 10
10/08/13
CORRECTIVE, PREVENTIVE and
IMPROVEMENT Page 4 of 12

Internal Audit
External Audit
Complaint, customer request
Complaint, user request
Others; Please specify
Name of the person who detected the NC or Improvement Opportunity
Process in which the existing NC, Potential, or Opportunity was detected.
Improvement.
Name of the process manager
Date when the APCM was generated

6.3. DESCRIPTION OF THE EXISTING, POTENTIAL OR NON-CONFORMITY

OPPORTUNITY FOR IMPROVEMENT

For the description of the Non-Conformity, it is necessary to document with a degree of

detail that facilitates the identification of the specific problem and the reference (number
of standard and/or basis of non-compliance) on which it is raised. Additionally, it must be
have evidence and specific criteria based on the following elements:

Real Nonconformity: Real Fact + Real Evidence + Non-fulfilled Requirement

Potential Nonconformity: Actual Fact + Actual Evidence + Requirement at Risk
if not fulfilled

Regarding the opportunities for improvement, two approaches are established as follows:

An increase or enhancement of a situation that is already favorable in the

execution of the process.
2. A decrease in the resources used to achieve the objectives of
process.

6.4. DETERMINE DEGREE OF SEVERITY

For the classification of the severity of non-conformities, the following are considered
following aspects:

No non-conformities related to the service.

No non-conformities related to the process.

4
 CODE: PR-002
10
08/10/13
CORRECTIVE, PREVENTIVE, and ...
IMPROVEMENT Page 5 of 12

Its magnitude is determined by the degree of severity of the consequences of

the encountered risks, mainly the following are present:
Degree of
TYPE OF RISK ENCOUNTERED
SEVERITY
High possibility of repetition.
High financial cost

HIGH High cost of image and quality

The requirements established by the client are not met.
organization or the legal ones.
A service standard requirement is not met.
Low likelihood of repetition.
Isolated but serious incident.
Average or low financial cost.
MIDDLE It doesn't necessarily produce a bad image.
The service has one or more major defects.
A service standard requirement is not being met
partially.

Isolated non-serious incident.

Low financial cost.

The service has one or more minor defects.
UNDER
A requirement of the assurance model is not met in
some aspect of form or quantity.
All those who do not present major severity for the
service, the process or the Quality system.
Table No. 1

If you cannot locate the risk in the previous table and therefore cannot
classify the non-conformity, the Quality and Projects Coordinator and/or the Assistant
Quality must carry out the corresponding classification.

When the Non-Conformity arises from "PQR", the results of the treatment of the
Non-conformities must be communicated by the customer service analyst.
in writing to the claimant, this communication can be made by sending a copy
of the document after defining the corrective actions, or informing them via

5
 CODE: PR-002
10
10/08/13
CORRECTIVE, PREVENTIVE, and
IMPROVEMENT Page 6 of 12

email. For this purpose, a copy of the communication must be kept as

evidence that the claim has been addressed.

6.5. CAUSE ANALYSIS

For the cause analysis, the quality assistant will meet with the people.
involved in the failure, for which the use of different tools will be made and
methodologies to identify the cause(s) of the reported problem
conformity. For this, the following methodology will be taken into account:

. Determine Work Team

In order to determine the work team for the analysis of causes and
actions to take in order to eliminate the cause of the non-conformity, and
depending on the degree of severity; it should be structured as follows:
High and medium severity level: To carry out the analysis of the causes
from this class of Non-Conformities, the Coordinator must meet,
Quality and Projects or the person designated by them, with the responsible
of the process that must outline the possible causes and the action to be taken for
eliminate the nonconformity
Low severity level: In this case, there is no commission. Only the
person responsible for the involved process or the person that he/she designates,
They must investigate the causes and actions to be taken.

Once the problem and the most probable causes have been clearly identified, one
must be filled out in the form FM-004 'Request for Corrective, Preventive Action'
or Improvement", in the fields:

TECHNIQUE USED "For the analysis"

CAUSES ANALYSIS
NAMES OF THE PEOPLE WHO PARTICIPATED IN THE ANALYSIS

Correction: The leader of the process involving the breach must raise the
immediate correction that will be made to the failure, for this they will register the correction and the
following data:

o Action or activity to be developed

o Name of the person responsible for implementation

6
 CODE: PR-002
10
10/08/13
CORRECTIVE, PREVENTIVE and
IMPROVEMENT Page 7 of 12

o Planned dates for implementation

Action Plan: The leader of the process involving the breach must raise
the corrective, preventive or immediate improvement action that will be carried out and the
following data:

o Action or activity to be developed

o Name of the person responsible for implementation
o Planned dates for implementation

6.6. MONITORING, CONTROL AND CLOSURE

The follow-up on the review of compliance with the correction and APCM must
to be carried out by the Quality Assistant who must verify that these have been
carried out, are effective, adequate and appropriate, thus ensuring that this does not
it will happen again and taking responsibility to do it properly and within the deadline
based on the results and the evidence confirm compliance with the
activity and measurements according to the selected criterion.

For this, the FM-004 form 'Request for preventive action' is completed.
corrective and/or improvement, in the section 'Follow-up', recording the findings
of the follow-up, the responsible person and the follow-up date, the verification of whether the
The action was effective or ineffective. Then it is determined whether the action is closed or not.
put the name of the Quality and Projects Coordinator and the closing date of the
same. With this information, consolidation will be carried out in the FM-078 'Balance of
Actions”, in order to establish a report that determines the effectiveness of the system.

In case the action(s) taken are not effective, the action is not closed.
corrective, preventive, or improvement, indicating any observations you consider
opportune, it being necessary to generate a new record with a new action plan,
that describes the consecutive action of the previous one from which it is derived and
registering progress percentage in the FM-078 'Balance of Actions'.

7. RECORDS

FM-004 REQUEST FOR PREVENTIVE, CORRECTIVE, or ACTION

IMPROVEMENT

7
 CODE: PR-002
10
08/10/13
CORRECTIVE, PREVENTIVE and
IMPROVEMENT Page 8 of 12

8. MEASUREMENT AND CONTROL

For the measurement of this process, the application of PR-003 will be taken into account.
Follow-up on preventive, corrective, and improvement actions and/or plans
Improvement, which will determine the effectiveness in closing actions
established.

9. CHANGE CONTROL

VERSION DESCRIPTION OF CHANGE APPLICATION DATE

01 Original Document 2004-010
02 Inclusion process, Modification procedure
02 Modification FM-004/01 2004-029
03 Procedure Modification, FM-004/02 Modification 2004-039 2005-049
04 Inclusion processes
05 Modification FM-004/4
06 Modification FM-004/5 2008-102
07 Update 2010-132
08 Update structural change 2011-118
09 Corrective and Preventive Action and Improvement Unification 2012-0705
10 Modification FM-004 August 10, 2013

PREPARED BY: REVIEWED BY:

Carolina Verano V. Bixmar Lagos B.

Quality Assistant Quality and Projects Coordinator
APPROVED AND AUTHORIZED BY:

APPROVAL DATE:
08/10/2013
Bixmar Lagos B.
Representative of the Directorate

8
 CODE: PR-002
10
10/08/13
CORRECTIVE, PREVENTIVE and
IMPROVEMENT Page 9 of 12

10. ANNEXES

10.1 REQUEST FOR PREVENTIVE, CORRECTIVE, and IMPROVEMENT ACTION FM-004

9
 CODE: PR-002
10
10/08/13
CORRECTIVE, PREVENTIVE actions and of
IMPROVEMENT Page 10 of 12

10
 CODE: PR-002
10
10/08/13
CORRECTIVE, PREVENTIVE actions and of
IMPROVE Page 11 of 12

11
 PR-002
10
08/10/13
CORRECTIVE, PREVENTIVE, and actions of
IMPROVEMENT Page 12 of 12

No. DESCRIPTION FLOWCHART REGISTER RESPONSIBLE

Any person can
detect the APCs as well as the Coordinator of
1 opportunities for improvement. Who Quality and Project FM-004
the detection must be communicated to it Assistant of
start the registration. Quality, Leader of
process.

Once a No is detected Process leader

Conformity existing o Coordinator FM-004
2 potential, the person responsible for Quality and Projects
process, you must register it in the Assistant of
format, delivering quality
this is up to the quality manager.

The identification of the sources

it is essential to determine Process leader
3 the possibility of occurrence. Coordinator
Quality and Projects FM-004
Assistant of
quality

Determine the degree of severity Process leader

4 of non-conformity, of Coordinator
agreement. Its magnitude is given Quality and Projects
due to the severity degree of the Assistant of FM-004
consequences quality

Analyze the causes that originated the Process Leader

Non-compliance, a meeting is held Coordinator
5 group that will determine them and will give Quality and Projects
possible solutions Assistant of FM-004
quality

The monitoring, control, and closure.

The review of compliance with
the correction and the corrective, the
the responsible person must carry out FM-004
assigned identifying what Assistant of
6 they have been effective, Quality
suitable y convenient,
ensuring that this does not
it happens again

12