QS-112
Core Quality Systems and Quality Events
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1.0 Purpose
This procedure provides an overview of Core Quality System(s) (CQS) used to manage cGMP
activities and the events that trigger these quality systems.
2.0 Scope
This procedure only applies to CQS listed in Table 1 and provides instructions common to each
of these systems. Separate SOPs as referenced .in Table 1 provide details necessary for
execution of each CQS / Event Type.
3.0 Responsibility
3.1 It is the responsibility of Directors, Managers and Supervisors to:
3.1.1 Understand that the CQS defined herein exist and are necessary in
circumstances defined in Table 1.
3.1.2 Refer to additional procedures defined in Table 1 as necessary when working
with a CQS for a specific event type.
3.2 It is the responsibility of Directors, Managers, and Supervisors assigned to initiate or
complete documentation of an event to:
3.2.1. Follow the instructions defined in this procedure.
3.2.2 Have documented training for procedures defined in Table 1 specific to events
assigned.
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3.2.3 Refer to additional procedures defined in Table 1 as necessary when executing a
specific CQS for an event type.
3.3. ‘It is the responsibility of Document Control / Quality to:
3.3.1 Assign and log event numbers.
3.32 Assign event due dates.
Diodes Approve or reject requests for event numbers.
3.3.4 Approve or reject event due date extensions, event cancellations, and/or event
revisions.
3.3.0 Approve or reject event closures.
3.3.6 It is the responsibility of the Training Department to:
3.3.6.1 Provide New Hire and Annual refresher training regarding the
procedures established within this SOP to all New Hire and existing
employees.
4.0 Definitions
4.1 DC — Document Control
4.2 CQS-—Core Quality System(s) is a system (i.e. Standard Operating Procedure (SOP) or
combination of SOPs) that handle and manage a quality event and that are within the
scope of this SOP as defined in Table 1. NOTE: There are Quality Systems outside the
scope of this SOP that handle Quality Events; however, they do not meet this definition
of CQS.
4.3. Quality Event — An event that triggers the use of a CQS and that is subject to cGMP
regulations.
4.4 eGMP — Current Good Manufacturing Practices as defined by regulations associated
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with the manufacture, testing, holding, etc. of a food, dietary supplement, drug product,
or device manufactured by Jon Labs.
4.5 OOS — Out of Specification —a result for a test performed does not meet established
acceptance criteria.
4.6 OOT — Out of Trend — a result for a test performed that meets established acceptance
criteria, but is not statistically consistent with historical trends.
4.7 AR — Aberrant Result — a result for a test performed that meets established acceptance
criteria, but is considered atypical, abnormal, anomalous, deviant, irregular,
questionable, or unexpected.
4.8 Adverse Event — Any health-related event associated with the use of a cosmetic,
dietary supplement, or OTC that is adverse.
4.9 Serious Adverse Event — Results in death, a life-threatening experience, inpatient
hospitalization, a persistent or significant disability or incapacity, a congenital
anomaly/birth defect, or one that requires medical or surgical intervention to prevent
such serious outcomes.
4.10 Non-Conforming Result (NCR) - any end value or result that does not meet a pre-
established specification or expectation.
5.0 References
Sel QS-112-F1, Form, Quality Event Extension Request
Due QS-112-F2, Form, Quality Event Cancellation Request
5.3 QS-112-F3, Form, Quality Event Amendment Request
A-118, SOP, Management —— of Quality Metrics
5.4 5:5 C-502, SOP, Record Storage, Retention, and Destruction
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5.6 D-105, SOP, Out of Specification/Out of Trend Investigation
5.7 C-201, SOP, Deviation and Investigation Procedure
5.8 QS-108, SOP, Corrective and Preventive Action (CAPA)
5.9 QS-113, SOP, Effectiveness Checks (EC)
5.10 QS-101, SOP, Complaints
5.11 QS-102, SOP, Adverse Events
5.12 C-403, SOP, Change Control Procedure
5.13. C-105, SOP, Protocol and Report Document Requirements
5.14 QS-114, SOP, Quality Risk Management
5.15 D-126, SOP, Non-Conforming Results in the QC Laboratory
6.0 Procedure
6.1 CQS / Event Types
6.1.1 The table below (Table 1) lists all quality event types subject to this SOP and
provides reference to detailed instructions for processing each type.
Table 1
Eve C nt Q T S y / pe Event Type Name - CQS / Event Type Description noe BOE
Cede
eference
Investigation — This CQS manages the investigation of laboratory results
INV that are OOS. This procedure also allows the investigation of results that D-105
are OOT or AR.
Deviation — This CQS manages both planned and unplanned deviations
from procedures, batch records, and nonconformities related to products,
DEV materials, equipment, processes, quality systems, etc. Handle C-201
nonconformities associated with OOS or OOT lab results using the INV
COS.
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Core Quality Systems and Quality Events
CQS/
Event Type Event Type Name - CQS / Event Type Description CQS SOP
Code Reference
Corrective Action Preventative Action — This CQS tracks progress and
CAPA completion of CAPA associated with other applicable event types. The QS-108
most common triggers for this CQS are INV and DEV events.
Effectiveness Check — This CQS provides a mechanism and feedback loop
EC to check the effectiveness of executed CAPA. When a CAPA requires QS-113
follow-up for effectiveness this CQS is required.
COMP Complaint — This CQS manages the processing of complaints received QS-101
about manufactured products and is triggered when a complaint is received.
Adverse Event — This CQS manages the processing of adverse events and
AE is triggered when a complaint is received that meets the definition of an QS-102
adverse event.
Change Control — This CQS manages changes to cGMP documents,
CC systems, equipment, software, etc. The CQS is triggered when Ion Labs C-403
personnel requests an applicable change.
Protocol — This CQS tracks and manages various types of protocols used to
PRTCL govern non-routine processes. Ion Labs personnel use this CQS when they C-105
request a protocol.
RPT Report — This CQS tracks and manages various types of reports. Ion Labs 0-105
personnel use this CQS when they request a report.
Non-Conforming Result — This CQS manages any non-conforming result
NCR D-126
that meets the definition as a minor category.
6.2 Events with impact to multiple CQS
6.2.1 If an event would trigger more than one CQS, the event must be documented in
each applicable quality system with the following exceptions:
6.2.1.1 Investigations / Deviations
6.2.1.1.1 If a documented investigation discovers that an OOS is a
result of a deviation, document the deviation within the
investigation system. A separate deviation event is not
required.
6.2.1.1.2 Ifa documented deviation generates an OOS, document the
OOS within the deviation system. A separate investigation
event is not required.
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6.2.1.2 {Complaints or Adverse Events} / {Investigation or Deviation}
6.2.1.2.1 Ifa customer complaint or adverse event discovers either an
OOS or a deviation not previously discovered /
documented, then document the deviation and/or OOS
investigation within the complaint system. A separate
deviation and/or investigation event is not required.
6.2.2 While the exceptions listed above do not require duplicated documentation
within the listed events, it is acceptable to initiate an event for each CQS
impacted.
6.3. Event Numbers
6.3.1 DC is responsible for assigning a unique number for each quality event
applicable to this procedure. DC will assign numbers using the following
format:
6.3.1.1 [Event Type] — [Year] — [####]
6.3.1.2 Where:
6.3.1.2.1_ [Event Type] — Use the event type code characters defined
in Table 1 for the event type.
6.3.1.2.2 [Year] — Use the last two digits of the year the event
started/opened.
6.3.1.2.3 [####] — A sequential number representing the count of
numbers assigned to that event type for the given year
starting at 0001.
6.3.2 Table 2 below provides example event number.
Table 2
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Example Event Number
The third deviation issued in 2018 DEV-18-0003
The fifth investigation issued in 2019 INV-19-0005
Note: The term “event number” is a generic reference to the number assigned to an event as defined
here. A more specific reference to a specific type of event number (i.e. deviation number,
change control number, etc.) may be used interchangeably with the term “event number” in
documentation that references or discusses these numbers (i.e. SOPs, Protocols, Reports, cross
references on documentation, etc.) For example, reference to a specific deviation can reference
the number as “event number — DEV-18-0003” or as “deviation number DEV-18-0003.”
6.4 Event Log
6.4.1 DC will maintain a spreadsheet of each event issued and event number. At a
minimum, the following information will be maintained in the log:
6.4.1.1 Event number
6.4.1.2 Event revision (if applicable)
6.4.1.3 Event Title / Description
6.4.1.4 Event logged by Initials / Date
6.4.1.5 Event cancellation — This is left blank unless the event is actually
cancelled
6.5 Event Initiation / Closure
6.5.1 Each CQS has forms specific to associated events that are used to initiate and
close those events.
6.5.2 DC will assign event numbers, and update the event log upon completion and
approval applicable initiation form(s).
6.5.3. DC will close events upon completion and approval applicable closure form(s).
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6.6 Due Dates and Extensions
6.6.1 Each quality event is assigned a due date. Closure of an event on or before the
assigned due date IS NOT a requirement for compliance. Due dates are
assigned as a process management tool and to provide management with
information about how various individuals and departments are able to adhere to
assigned due dates. If an event is closed after an assigned due date, a deviation
is not required.
6.6.2 Quality may choose to open a deviation if a delay in closure of an event poses a
significant risk to safety or compliance.
6.6.3 Default due dates are defined in Table 3. Assign the default due date if
reasonable. Each situation may require either more or less time. For example, if
the event closure is necessary to minimize risk to a product or cGMP system,
then assign a shorter due date. Conversely, if time is required to close the event,
then allow that time with a longer due date.
Table 3
Event Type Code Default Due Date
INV 30 days from open
DEV 30 days from open
CAPA 30 days from open
EC 90 days from implementation
COMP 45 days from open
AE 45 days from open
CC 30 days from open
PRTCL 30 days from open
RPT 30 days from open
NCR 30 days from open
6.6.4 After assignment of a due date, circumstances may prevent completion of an
event on time. If there is a justified need for an extension, use form QS-112-F1
Quality Event Extension Request to request a new due date.
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6.6.5 An extension IS NOT required just because an event is closed after an assigned
due date.
6.6.6 DC will update due dates based on approved extensions, and will track the
number of times a due date is extended.
Note: The quality department tabulates events that are open and past due and provides
them for consideration during the monthly management review of quality
metrics. Additionally, the number of times an event is extended is reviewed.
Refer to SOP A-118 Monthly Review of Quality Metrics. This procedure
provides a mechanism to provide awareness and resources and to set priorities to
close quality events.
6.7 Event Cancellation
6.7.1 Cancel Events using Form QS-112-F2 Event Cancellation Request. This form
provides the mechanism for the event owner to provide justification of the
cancellation and for DC to approve the cancellation. DC will not approve the
cancellation of an event without an acceptable justification.
6.7.2 DC will initial and date the cancellation of the event in the event log upon
approval of the cancellation request.
6.8 Event Amendment / Revision
6.8.1 In the circumstance that a quality event has been closed but needs to be
amended or revised a new revision of that quality event will be made and logged
just like a new event of that type, but will use the same event number with an
incremented revision number.
6.8.2 Initiate an event amendment / revision using Form QS-112-F3 Event
Amendment Request.
6.8.3 DC will log each event revision into the same event log used for that event type.
Treat the amendment / revision as a new event with respect to open, due, and
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closed dates.
6.8.4 Each initial quality event will be given a revision number of 0, while any
following revision number will increase sequentially for each new revision.
6.8.5 Add additional documentation to the original event documentation and use good
documentation practices when correcting original documentation.
6.8.6 Use fresh forms from the original CQS to amend/revise the documentation as
applicable. For example, use a blank form used to close a deviation to
document approval of the revision. Alternately, memorandums, letters, reports,
etc. may be used to approve the revision; however, the same level of approval or
higher used to approve the original event is required for any revisions (i.e. same
departments represented and same managerial levels or higher represented).
6.9 Record Management
6.9.1. DC will maintain original event documents.
6.9.2 DC will scan completed event documents and file electronically.
6.9.3. Maintain records as defined in SOP C-502 Record Storage, Retention, and
Destruction.
6.9.4 Issue copies of event documentation to subject records as applicable. For
example, file a copy of a deviation or investigation with the subject batch
record. Mark / Stamp official copies with the word “Copy” on the first page of
the copy.
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7.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 12/30/19 | New procedure. N/A K. Burris | - | - |
| 1 | 06/08/22 | Added NCR scope to procedure. Changed responsibility CC- section. Updated forms. | 22-0259 | I. Sassman |