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QMS - Coggle Diagram
QMS
ISO 17025
Internal Audit Assessment
What/ Definition
An independent and systematic assessment of the quality management system to determine whether the quality activities and related results comply to the planned arrangement and whether this arrangement is carried out effectively and are suitable to achieve the objectives
quality activities (
risk lying within
); related results comply (
conformance to standards and regulatory requirements
); arrangement is carried out effectively (
effectiveness in processes from audit evidence collected
); achieve its objectives (
adequacy if resource requirements)
Objectives/ Roles
To identify and eliminate risk exist in the lab qms: impartiality, independency, deviation from existing lab activities
Audit as statement of conformance to standards and regulatory requirments
to determine the effectiveness in process from the audit report
to determine the adequacy of resource requirements in obtaining quality objectives
Types
Internal/ External
First Party
Second party
Third party
General ISO Requirements:
Audit Program
Audit schedules; Plan and procedures for auditing; recoding findings, taking timely corrective actions(scheduled); notify customer of data problems
Have document procedures
Procedures
Specifies responsilbility; define authority and respinsibility of auditors
Identify scope of audit
schedule audit
Training
Detail steps in auditing
Prepare forms and
checklist
act as a framework for auditing; focus and consistent in standardizing auditing process; do not miss out any aspect of qms
Perform auditing
Complete records (report)
Implement and follow up on corrective actions
Result documented and report to management for review
Prompt follow up actions
Auditors independent
Quality Auditors
Systematic and independent
Experienced auditors
familiar with lab operations, preferably the type of test under audit
integrity; acts professionally in judgement
Quality Control & Quality Assessment
Quality Assurance
process oriented: planned and systematic actions to provide confidence that a product. process or service meet the requirements for quality
QA in Measurements
Test Control Samples
Sampling;Labeling(unambiguous source identification; Tranportation(purity of sample); Storage; Preparation(following SOP)
Facilities and Environment
Obeying construction codes; fore prevention measures; environmental, health and safety considerations, factors affecting analytical qualities
Test Method
Correct use of instruments and measurements
Keeping equipment records and maintanance; Scheduled Calibration; Setting criteria for daily checking of instrument accuracy; following recalibration trend by control charts
Quality Control
product oriented: operational techniques and activities that are used to fulfill requirements for qualities
Steps to achieve acceptable results in chemical analysis
Samples: Properly drawn, labeled and preserved
Reducing analytical errors: Validating appropriate analytical method; training staff for technical competence
Use of reference materials and laboratory control samples (internal QA)
Participate in interlab and proficiency testing programs (external QA)
Expressing confidence limit of a measurement: estimating its MU
Purpose of conducting qc on analytical procedure
to
provide evidence on the reliability
of analytical results
Statistical control: factors affecting the measurement of uncertainty has not deteriorate since the method validation and verification process
Analysis of QC material
= material of known composition which is similar to test materials in terms of matrix and analyte conc.;;
QC material: prepared by lab for QC purpose; may be excess materials from previous batch of analysis; may be certified reference materials of sufficient stability and in sufficient quantity
Analyze alongside with test materials (same treatment)
Data collected over time is displayed in control chart
Metrological Tracebility
Importance?
to provide confidence that the measurement agree with the National Standards within stated uncertainty
ensure measurements are equivalent to those made using different instruments from different suppliers
How?(ensure measurement are traceble to SI)
Technical possible
calibration made by competent lab
use of certified values from CRM provided by competent provider
Comparison, whether directly/indirectly with SI (national standards)
Technically impossible
What is needed to make sure that QC is acceptable
Quality Control Methods
Interlab Testing
Proficiency Testing
Objectives/ Roles
to provide confidence to laboratory clients that you are delivering the quality result that they require
to determine lab's performance
to establish effectiveness and comparibility of new test or measurement methods
to assign value to reference materials and assess their suitablility for use in specific test and measurement procedure
Process
Method Validation
LOQ Limit of Quantitation
Specificity
LOD Limit of Detection
Linearity
Precision
Range
Accuracy
Robustness/ Ruggedness
Measurement Uncertainty
Decision Rule and Statement of Conformity
Decision Rule
: Rule that describe how measurement uncertainty is accounted for when stating a conformity with specified requirement
decision rule is prescribed by the customer, regulations or normative documents ( a broad category of documents that provides rules, guidelines or characteristic of activities or their results. eg legal. standards). then the consideration of risk is not necessary
Statement of conformity
: an expression referring to the conformance to a specification or standard in which the decision rule employed was documented.
indicates whether a measuring devive complies with specifications (eg. manufacturer's specifications) at the end of calibration/ or not
Decision rule is done through communication between the lab and customers
Difference between 2005 and 2017
2005/2017
Scope
including testing, calibration and sampling associated with subsequent calibration and testing (addition of sampling)
testing and calibration activities
new structure
adopted to align the standard of other ISO/IEC conformity assessment standard such as ISO/IEC 17000 series
Process Approach
emphasize on the result rather than detailed description on the task and steps
important decision based on test results
greater focus in revision ensuring that lab produce valid and reliable result
Information technologies
incorporates the usage of computer system, electronic records and production of electronic results and reports
More risk based and less procedure based
Roundtable Sustainable Palm Oil (RSPO)
Types of Certification
Principal and Criteria
Supply Chain Certification
Benefits
assurance of transparency and credibility
ensure credibility of sustaninable palm oil at the end of supply chain
non-profit org that involve 7 sectors from producer to customers in
developing an implementing global standards for sustainability
where
a set of environmental and social criteria is set
to produce certified sustainable palm oil,
along
minimizing negative impact of palm oil cultivation to environment and communities in related regions.
Food Safety Management System
ISO 22000
Hazard Analysis, Critical Control Point System (HACCP)
Principal 1 (Hazard Analysisi)
listing steps in process and identifying hazards that are likely to occur, usually focus on hazrds that can be prevented, minimise or eliminated
Principal 2 (CCP)
a point, step or procedure where control can be applied and food safety hazards can be prevented, eliminated or reduced to acceptable levels
Principal 3(Control limits)
max or min value which chemical, biological, or physical parameter must be controlled at CCP
4 (Monitor CCP)
measurement of critical limit at each CCP (who, how, when ,how frequent)
5 (Corrective Actions)
procedures that follows when a deviation in critical limits occur
6 (verification)
determine validity of HACCP plan and that system is operating according to plan
auditing of CCPs
record review
prior shipment review
instrument calibration
product testing
[7 (Record Keeping) (HACCP plan)]
HACCP team
product description
flow diagram
hazard analysis
CCPs' identified
Critical Limits
Corrective Actions
Record Keeping Procedures
Verification Procedure
Good Manufacturing Process (GMP)
A (Personnel regarding personal hygiene)
Personal hygiene and cleaniliness
Food management education and training
B(Buildings and Facilities)
Requirements for maintenance, layout, operations of food processing facilities
Maintenance of grounds
sanitary operations
adequate sanitary facilities and controls
C (Equipment)
Requirements and expectations for the design, construction, and maintenance of equipment and utensils
E(Production and Process Control)
general sanitation process
monitoring of physical factors (CCP)
general requirements for warehousing and distributions
G (Defect Action Limit, DAL)
define maximum DALs for a defect that is natural or unavoidable even when food is produced under GMPs as set out in other subpart. (usually not hazardous to health at low levels)
HALAL
(certified to MS1500:2009)
complied with requirements that the production, preparation, handling and storage of food and shall be verified through site inspection by competent authority
Benefits
Give confidence to business. customer, supplier, and other stakeholder taht the product is halal and syariah compliant
increase profitability
Penetrating largest market share in the food sector
KOSHER
SEDEX (Supplier Ethical Data Exchange)
Importance
Assisting a company in identifying, mitigating and preventing risks in health and safety
helping company comply with legislation
support human and environmental right due diligence effort (labour rights)
global membership organisation for ten thousands of companies
to manage their performance around labour rights, health and safety, environmental and business ethics