Distribution Centre:Health Canada Audits & Inspections - Revision history

Johnt at 16:32, 8 February 2023

2023-02-08T16:32:23Z

Johnt at 17:21, 6 October 2017

2017-10-06T17:21:57Z

Johnt at 17:20, 6 October 2017

2017-10-06T17:20:46Z

Geraldp at 20:58, 5 October 2017

2017-10-05T20:58:04Z

Geraldp at 20:55, 5 October 2017

2017-10-05T20:55:57Z

Johnt at 18:25, 4 October 2017

2017-10-04T18:25:42Z

Johnt at 18:21, 4 October 2017

2017-10-04T18:21:20Z

Johnt at 18:19, 4 October 2017

2017-10-04T18:19:47Z

Johnt at 18:18, 4 October 2017

2017-10-04T18:18:36Z

Johnt at 17:58, 4 October 2017

2017-10-04T17:58:39Z

@@ Line 20: / Line 20: @@
 * Ensure good communication with all colleagues that could be involved in the audit and review "The Golden Rules" & topics that will typically be covered during the inspection
 * Make sure suitable location is booked for the duration of the time that an inspector will be on-site (suggestion to book the boardroom or the UTC for the day)
 ==Golden Rules==

@@ Line 65: / Line 65: @@
 '''Rule #6'''
 * When the inspector requests a document
-* Provide the required document ONLY
+** Provide the required document ONLY
 * When the inspector asks a question
 ** Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary

@@ Line 23: / Line 23: @@
 ==Golden Rules==
 '''Rule #1'''
-# Be well prepared - it's important to be knowledgeable of the HC regulations
+* Be well prepared - it's important to be knowledgeable of the HC regulations
 * Where possible - simulate inspection process in the organization
 * Test internal SOP (Standard Operating Procedures)
@@ Line 35: / Line 35: @@
 * Don't - Engage in unconstructive arguments
-# Ensure that documents are readily retrievable
+* Ensure that documents are readily retrievable
-# Use relevant guidelines as resources
+* Use relevant guidelines as resources
-# Important to have senior management support as preparation takes resources
+* Important to have senior management support as preparation takes resources
 '''Rule #2'''
-# Good documentation practices
+* Good documentation practices
 * Accurate records
 * Record all necessary information immediately upon completion of a task
@@ Line 52: / Line 53: @@
 '''Rule #3'''
-# Write good procedures and follow them - "Walk the talk"
+* Write good procedures and follow them - "Walk the talk"
 '''Rule #4'''
-# Train and develop staff
+* Train and develop staff
-## Training should be documented on a training form
+* Training should be documented on a training form
 '''Rule #5'''
-# Perform regular audits
+* Perform regular audits
 * Self inspections - complete, update SOP's as needed
 '''Rule #6'''
-# When the inspector requests a document
+* When the inspector requests a document
 * Provide the required document ONLY
-# When the inspector asks a question
+* When the inspector asks a question
-* Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
+** Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
-* If you don't know that answer - DON'T guess - state you will find out and come back with the information
+** If you don't know that answer - DON'T guess - state you will find out and come back with the information
 '''Rule #7'''
-# Key people must be present on the day of the inspection - if this is not possible, then ensure a suitable back up or request a reschedule if possible
+* Key people must be present on the day of the inspection - if this is not possible, then ensure a suitable back up or request a reschedule if possible
-# Important documents to be available
+* Important documents to be available
 * Organizational Chart
 * SOP's

@@ Line 76: / Line 76: @@
 * Training records
 * Transactional details
 [[Category:Health Canada]]

← Older revision		Revision as of 20:55, 5 October 2017
Line 77:		Line 77:
	* Transactional details		* Transactional details

−	[[Category:Distribution Centre]]
	[[Category:Health Canada]]		[[Category:Health Canada]]

@@ Line 23: / Line 23: @@
 '''Rule #1'''
 # Be well prepared - it's important to be knowledgeable of the HC regulations
-** Where possible - simulate inspection process in the organization
+* Where possible - simulate inspection process in the organization
-** Test internal SOP (Standard Operating Procedures)
+* Test internal SOP (Standard Operating Procedures)
-** Test staff knowledge
+* Test staff knowledge
-** How are questions answered
+* How are questions answered
 '' Inspection "Don'ts..."''
-** Don't - Guess, lie or make misleading statements
+* Don't - Guess, lie or make misleading statements
-** Don't - Get uptight, overly anxious, or defensive
+* Don't - Get uptight, overly anxious, or defensive
-** Don't - Volunteer more information than necessary to answer the question
+* Don't - Volunteer more information than necessary to answer the question
-** Don't - Engage in unconstructive arguments
+* Don't - Engage in unconstructive arguments
 # Ensure that documents are readily retrievable
@@ Line 41: / Line 41: @@
 # Good documentation practices
 * Accurate records
-** Record all necessary information immediately upon completion of a task
+* Record all necessary information immediately upon completion of a task
-** Never trust your memory or write results on loose pieces of paper or a post-it note
+* Never trust your memory or write results on loose pieces of paper or a post-it note
-** Write your name legibly in ink.  Remember that by signing records you are certifying that the record is correct and that you have performed the task as per the defined procedure.
+* Write your name legibly in ink.  Remember that by signing records you are certifying that the record is correct and that you have performed the task as per the defined procedure.
-** Draw a single line through any mistakes, and initial and date the correction.  Include a reason for the correction at the bottom of the page.
+* Draw a single line through any mistakes, and initial and date the correction.  Include a reason for the correction at the bottom of the page.
-** Record details if you deviate from a procedure
+* Record details if you deviate from a procedure
-** Never assume that undocumentated work has been properly completed - if it's not written down then it didn't happen
+* Never assume that undocumentated work has been properly completed - if it's not written down then it didn't happen
-** Review SOP's and processes regularly to assure that they are up to date
+* Review SOP's and processes regularly to assure that they are up to date
-** Document changes (change control)
+* Document changes (change control)
 '''Rule #3'''
@@ Line 59: / Line 59: @@
 '''Rule #5'''
 # Perform regular audits
-** Self inspections - complete, update SOP's as needed
+* Self inspections - complete, update SOP's as needed
 '''Rule #6'''
 # When the inspector requests a document
-** Provide the required document ONLY
+* Provide the required document ONLY
 # When the inspector asks a question
-** Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
+* Answer the question directly and honestly - DO NOT provide any further details or information if it's not necessary
-** If you don't know that answer - DON'T guess - state you will find out and come back with the information
+* If you don't know that answer - DON'T guess - state you will find out and come back with the information
 '''Rule #7'''
 # Key people must be present on the day of the inspection - if this is not possible, then ensure a suitable back up or request a reschedule if possible
 # Important documents to be available
-** Organizational Chart
+* Organizational Chart
-** SOP's
+* SOP's
-** Training records
+* Training records
-** Transactional details
+* Transactional details
 [[Category:Distribution Centre]]