Guidelines for Developing SOPs

1
Guidelines for Developing SOPs Jere High,
Lancaster DHIA Paul Sauvé, CLS March 15,
2005 Lansing, Michigan
2
Council on Dairy Cattle Breeding Auditing
Procedures for Laboratories Effective January 1,
2005
3
Council on Dairy Cattle Breeding Auditing
Procedures for Laboratories Effective January 1,
2005 Reference Documents The lab manager must
have a functional up-to-date Lab Manual which
includes Standard Operating Procedures for CDCB
procedures for laboratories. In addition all
appropriate technical documents should be
available to laboratory technicians. Examples
include instrument manuals, MSDS sheets etc.
(Deadline is 2006 audit)
4
Formal and complete documentation of lab
procedures is now a CDCB requirement for
laboratory certification.
5
Formal and complete documentation of lab
procedures is now a CDCB requirement for
laboratory certification. The most appropriate
way to implement this requirement is to develop a
Lab Manual (sometimes called a Quality Manual)
which includes all SOPs or references a separate
Operations Manual.
6
Functions of The Lab Manual
7

• Functions of The Lab Manual
• Demonstrate competence to clients

8

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process

9

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process
• Aid in training of new staff

10

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process
• Aid in training of new staff
• Assist with internal review of policies and
  procedures

11

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process
• Aid in training of new staff
• Assist with internal review of policies and
  procedures
• Guarantee consistency of procedures among
  employees

12

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process
• Aid in training of new staff
• Assist with internal review of policies and
  procedures
• Guarantee consistency of procedures among
  employees
• Assist in identifying capital requirements
  (equipment)

13

• Functions of The Lab Manual
• Demonstrate competence to clients
• Assist in certification process
• Aid in training of new staff
• Assist with internal review of policies and
  procedures
• Guarantee consistency of procedures among
  employees
• Assist in identifying capital requirements
  (equipment)
• Assist in justification of other lab expenditures

14
Minimum Requirements of A Good Lab Manual
15
Minimum Requirements of A Good Lab
Manual Define the organization (structure,
size, organizational chart, key responsibilities)
16
Minimum Requirements of A Good Lab
Manual Define the organization (structure,
size, organizational chart, key
responsibilities) Human resources (job
descriptions, training policies and procedures,
qualifications, records, confidentiality
agreements, conflict of interest guidelines)
17
Minimum Requirements of A Good Lab
Manual Define the organization (structure,
size, organizational chart, key
responsibilities) Human resources (job
descriptions, training policies and procedures,
qualifications, records, confidentiality
agreements, conflict of interest
guidelines) Describe the work environment
(laboratory building, services, utilities, safety
requirements, security, waste disposal)
18
Minimum Requirements of A Good Lab Manual
(continued)
19
Minimum Requirements of A Good Lab Manual
(continued) Physical resources (test equipment,
calibration intervals, maintenance intervals)
20
Minimum Requirements of A Good Lab Manual
(continued) Physical resources (test equipment,
calibration intervals, maintenance
intervals) Inventory (requirements, approved
vendors, purchasing procedures)
21
Minimum Requirements of A Good Lab Manual
(continued) Physical resources (test equipment,
calibration intervals, maintenance
intervals) Inventory (requirements, approved
vendors, purchasing procedures) Define QC
requirements
22
Minimum Requirements of A Good Lab Manual
(continued) Physical resources (test equipment,
calibration intervals, maintenance
intervals) Inventory (requirements, approved
vendors, purchasing procedures) Define QC
requirements Define record keeping (data
collection, retention, storage, back-up)
23
Minimum Requirements of A Good Lab Manual
(continued) Physical resources (test equipment,
calibration intervals, maintenance
intervals) Inventory (requirements, approved
vendors, purchasing procedures) Define QC
requirements Define record keeping (data
collection, retention, storage, back-up) Standard
Operating Procedures (for EVERY aspect of lab
operation, short, simple, in a standard format
24
A separate SOP should be developed for each key
QC requirement of the CDCB Guidelines. These
are
25

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training

26

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)

27

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)

28

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)

29

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)
• Homogenization efficiency checks (IR analyzers)

30

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)
• Homogenization efficiency checks (IR analyzers)
• Purging efficiency checks (IR analyzers)

31

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)
• Homogenization efficiency checks (IR analyzers)
• Purging efficiency checks (IR analyzers)
• Pilot sample checks (IR and SCC analyzers)

32

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)
• Homogenization efficiency checks (IR analyzers)
• Purging efficiency checks (IR analyzers)
• Pilot sample checks (IR and SCC analyzers)
• Repeatability checks (IR and SCC analyzers)

33

• A separate SOP should be developed for each key
  QC requirement of the CDCB Guidelines. These
  are
• Manager and Lab Technician Training
• Analysis of Sample Unknowns (including
  submission of data)
• Calibration checks and adjustments (IR
  analyzers)
• Calibration checks and adjustments (SCC
  analyzers)
• Homogenization efficiency checks (IR analyzers)
• Purging efficiency checks (IR analyzers)
• Pilot sample checks (IR and SCC analyzers)
• Repeatability checks (IR and SCC analyzers)
• Zero checks and adjustments (IR and SCC
  analyzers)

34
Separate SOPs should also be developed for all
other key operational functions within the
laboratory. These include
35

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers

36

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.

37

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal

38

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis

39

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results

40

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results
• Validation of laboratory thermometers

41

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results
• Validation of laboratory thermometers
• Key preventative maintenance procedures
  (replacing desiccant)

42

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results
• Validation of laboratory thermometers
• Key preventative maintenance procedures
  (replacing desiccant)
• Cleaning of vials and lids (including addition
  of preservative)

43

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results
• Validation of laboratory thermometers
• Key preventative maintenance procedures
  (replacing desiccant)
• Cleaning of vials and lids (including addition
  of preservative)
• General housekeeping

44

• Separate SOPs should also be developed for all
  other key operational functions within the
  laboratory. These include
• Start-up and shut-down of analyzers
• Preparation of reagents, dyes, cleaning
  solutions, etc.
• Sample receipt, log-in, quality assessment,
  storage and disposal
• Sample preparation (heating, agitation) and
  sample analysis
• Collection, storage, editing and transmission of
  test results
• Validation of laboratory thermometers
• Key preventative maintenance procedures
  (replacing desiccant)
• Cleaning of vials and lids (including addition
  of preservative)
• General housekeeping
• Etc.

45
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are
46
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title
47
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number
48
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date
49
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date 4. a
statement of authority (The Lab Manager is
responsible for...)
50
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date 4. a
statement of authority (The Lab Manager is
responsible for...) 5. a statement of the
scope referencing appropriate policies
51
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date 4. a
statement of authority (The Lab Manager is
responsible for...) 5. a statement of the
scope referencing appropriate policies 6.
detailed steps for carrying out the task and for
documenting the corresponding results
52
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date 4. a
statement of authority (The Lab Manager is
responsible for...) 5. a statement of the
scope referencing appropriate policies 6.
detailed steps for carrying out the task and for
documenting the corresponding results 7.
an appropriate page numbering system to ensure
that no information is missing or excluded.
53
SOPs should be organized, up-to-date and
available for immediate reference by all lab
staff. There are seven requirements for each
SOP. These are 1. a title 2. a procedure
number 3. a revision number and date 4. a
statement of authority (The Lab Manager is
responsible for...) 5. a statement of the
scope referencing appropriate policies 6.
detailed steps for carrying out the task and for
documenting the corresponding results 7.
an appropriate page numbering system to ensure
that no information is missing or
excluded. The SOPs should also reference (by
number) all other related procedures and/or forms.
54
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005
Scope Hourly zero checks and/or adjustments are
performed in order to monitor the stability of
infrared analyzers on an hourly basis during
routine testing of all DHI client samples.
Responsibility All Instrument Operators are
responsible for performing the hourly zero checks
in accordance with the following procedure.
- PAGE 1 OF 2 -
55
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

- PAGE 2 OF 2 -
56
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

57
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

58
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

59
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

60
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

61
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

62
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

63
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

64
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

65
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

66
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

67
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

68
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

69
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

70
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

71
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

72
SOP 132
Hourly Zero Checks and Zero Adjustments (IR)
REVISION 002
February 15, 2005

• Procedure
• Sealed vials of zero solution (0.1 TX-100 ref.
  SOP 119) are held in the 42C waterbaths until
  needed.
• Immediately following the hourly pilot sample
  check (ref. SOP 131), one vial of zero solution
  is tested manually three times in succession.
• The second two fat and protein results are
  averaged and the values are recorded in the
  appropriate fields on Form 17C.
• If drift for either component exceeds /- 0.03,
  the zero is reset and the adjustment is noted by
  checking the appropriate box on Form 17C.
• If drift for either component exceeds /- 0.06,
  testing is discontinued and the Lab Manager or
  Shift Supervisor is consulted.

73
EVERY LAB IS DIFFERENT!
74
EVERY LAB IS DIFFERENT! It is not appropriate to
copy procedures from other laboratories, from
instrument manuals, or from the CDCB guidelines.
75
EVERY LAB IS DIFFERENT! It is not appropriate to
copy procedures from other laboratories, from
instrument manuals, or from the CDCB
guidelines. An appropriately skilled individual
should be able to complete any of the lab
procedures simply by following the detailed steps
presented in the SOP.
76
EVERY LAB IS DIFFERENT! It is not appropriate to
copy procedures from other laboratories, from
instrument manuals, or from the CDCB
guidelines. An appropriately skilled individual
should be able to complete any of the lab
procedures simply by following the detailed steps
presented in the SOP. The QC Auditor will test
the effectiveness of SOPs as part of the on-site
lab visit!
77
The Lab Manual and SOPs define YOUR organization.
78
The Lab Manual and SOPs define YOUR
organization. Templates are available which
provide the general titles and headers but do not
include specific steps associated with each
procedure.
79
The Lab Manual and SOPs define YOUR
organization. Templates are available which
provide the general titles and headers but do not
include specific steps associated with each
procedure. IT IS CRITICAL THAT YOU DEVELOP YOUR
OWN SOPS!
80
The Lab Manual and SOPs define YOUR
organization. Templates are available which
provide the general titles and headers but do not
include specific steps associated with each
procedure. IT IS CRITICAL THAT YOU DEVELOP YOUR
OWN SOPS! To receive a copy of these templates
email the lab auditor.
81
The Lab Manual and SOPs define YOUR
organization. Templates are available which
provide the general titles and headers but do not
include specific steps associated with each
procedure. IT IS CRITICAL THAT YOU DEVELOP YOUR
OWN SOPS! To receive a copy of these templates
email the lab auditor. jpsauve_at_bellnet.ca