risk analysis: implementation and changing sops · risk analysis: implementation and changing sops...

Risk Analysis: Implementation and Changing SOPs

Cynthia Mangione

Risk Assessment

ISO/IEC 17025:20174.1 Impartiality

4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise for its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.

4.1.5 If a risk to impartiality is identified the laboratory shall be able to demonstrate how it eliminates or minimizes such risk.

NY State Agriculture & Markets Food Laboratory

Quality Manual - new

4.1 Impartiality

4.1.4 Laboratory management shall review and identify risks to impartiality during management review.

4.1.5 If a risk to impartiality is identified, management shall take appropriate action and document any actions taken.

Management Review

ISO/IEC 17025:20178.5 Actions to Address Risks and Opportunities

8.5.1 The laboratory shall consider the risksand opportunities associated with the laboratory activates in order to:

a. give assurance that the management system achieves its intended results;

b. enhance opportunities to achieve the purpose and objectives of the laboratory;

c. prevent, or reduce, undesired impacts and potential failures in the laboratory activities;

d. achieve improvement



8.5.1 The laboratory considers risks and opportunities associated with laboratory activities by utilizing weekly staff meetings to solicit information directly from employees, during audits, corrective action investigations, and during annual management reviews. In doing so the laboratory seeks to:

a. give assurance that the management system is achieving its intended results;

b. enhance opportunities to achieve the purpose and objectives of the laboratory;

c. prevent or reduce undesired impacts and potential failures in laboratory activities;

d. achieve improvement.


8.5.2 The laboratory shall plan:

a. actions to address these risks and opportunities;

b. how to;

• integrate and implement these actions into its management system;

• evaluate the effectiveness of these actions



8.5.2 When risk and/or opportunities are identified, and the laboratory determines a need or desire to address them specifically, the laboratory shall implement procedures outlined in GP-4-08.4 Preventive Action, Risk Assessment and Management. These procedures include planning, implementation and evaluation of any actions taken.


8.5.3 Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.



8.5.3 Actions taken to address risks and opportunities for improvement are proportional to the potential impact on the validity of laboratory results.


Preventive Action, Risk Assessment & Management SOP


Preventive Action, Risk Assessment &

Management SOP

5.1.1 When an opportunity for improvement to

a procedure or the management system

is identified through the use of staff

meetings, employee suggestions, control

chart monitoring, audits, or other risk

assessment activities it shall be brought

to the attention of the appropriate

section head and/or QAU.



Management SOP

5.1.2 The section head shall perform a risk

assessment of the improvement

opportunity. This can be done in

conjunction with a member of the QAU

and/or laboratory management.



Management SOP

5.2.4 In the case of a policy change or

implementation, it may be unnecessary and/or

impracticable to test its effectiveness. The QAU

and/or laboratory management shall perform a

risk assessment. Risk assessments may

include section heads. The risk assessment and

final decision about the change’s acceptability

shall be documented on the PAR form. If the

change is deemed acceptable it shall be

implemented.

ISO/IEC 17025:20178.8 Internal Audits

8.8.2 The laboratory shall:

The schedule and scope of the audit shall be determined based on a risk assessment.



8.8.2 The procedures for conducting internal

audits are described in GP-4-09 Internal

Audits, including records, reporting,

follow up activities, implementation of

corrective and/or preventive action, risk

analysis, etc.


Internal Audits SOP

5.2.1 Internal audit schedules and scopes shall

be determined based on a risk

assessment. At a minimum, internal

audits of the laboratory management

system shall be conducted at least once per accreditation cycle.


Internal Audits SOP

5.4.3.1 When audit risk assessments

identify opportunities for

improvement FR-PAR001:

Preventive Action Request Form

shall be filled out as per GP-4-08.4

Preventive Action, Risk Assessment

and Management.

ISO/IEC 17025:20178.9 Management Review

8.9.1 The laboratory management shall review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfillment of this document.

Management review shall include a review of nonconforming work for trends, Also, customer and personnel feedback and complaints shell be reviewed for trends.


Quality Manual - added

8.9.1(4.15.1) The Laboratory Director shall

conduct a review of the laboratory’s

management system annually. Section 8.9.2

below outlines topics that are to be

addressed. The goal of the management

review is to ensure the continuing suitability

and effectiveness of the management

system and to introduce necessary changes

or improvements, including risk analysis.

ISO/IEC 17025:20178.9 Management Review

8.9.2 The inputs to management review shall be recorded and shall include information related to the following:

(m) results of risk identification;



8.9.2 The inputs to management review shall

be recorded and shall include

information related to the following:

(m) results of risk identification


Management Review – QA Summary• Internal Audits

• Corrective Actions/Nonconforming Work

• Customer Complaints

• Preventive Actions/Risk Assessments

• Assessments from external bodies

• PT activities

• Monitoring Activities (Control Charts/Trends)

• Trainings

• Adequacy of Resources

• Future needs


Management Review – Section Summary• Changes to work volume/type

• Special requests for testing

• Adequacy of Resources

• Staff

• Equipment

• Facility enhancements

• Training

• Vender problems/ordering issues

• Future needs


Management Review – Mgt Summary• Changes external and internal issues

• Changes to capability/capacity

• Effectiveness of Management System and

Processes

• Summary of customer meetings

• Future needs

• Suitability of Policies and Procedures


Management Review

Questions?

Cynthia Mangione

[email protected]

P 518-549-0135

mailto:[email protected]

risk analysis: implementation and changing sops · risk analysis: implementation and changing sops...

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